Clinical Research Directory

Pain Control During ESWL Using Non-Opioid Analgesics

This prospective randomized controlled trial aims to compare the analgesic efficacy of three non-opioid analgesics (ibuprofen, paracetamol, and tenoxicam) during extracorporeal shock wave lithotripsy (ESWL). All patients undergoing ESWL will be randomly assigned into four groups including a placebo group. Pain intensity will be assessed using the Visual Analog Scale (VAS) at the 5th, 10th, 15th, and 20th minutes during the procedure. In addition to comparing analgesic efficacy, the study will evaluate patient-related and stone-related factors affecting pain perception, including body mass index, subcutaneous fat thickness, and stone density measured by Hounsfield Units. The study also aims to assess the relationship between analgesic efficacy, energy levels applied during ESWL, and treatment outcomes such as stone-free rates. The findings may contribute to optimizing individualized pain management strategies and improving treatment efficiency in ESWL procedures.

Pilot Study of Patient Navigation for Kidney Stone Patients After ED Visits

Patients who visit the emergency department for kidney stones are sometimes referred to urology for follow-up care but never complete that visit. Missing follow-up appointments can lead to worse outcomes, including recurrent pain, infection, or surgery. Research shows that patients who are socially or economically at risk (such as those with public insurance, lower income, or limited English proficiency) are more likely to experience these care gaps. This study will pilot a patient navigation program designed to help patients with urinary stone disease (USD) attend their scheduled urology appointments after being seen in the Emergency Department. Using an electronic health record (EHR) based prediction model developed in earlier research, patients at higher risk for being lost to follow-up will be identified and invited to participate. Each participant will be paired with a trained patient navigator who will assess barriers to care, provide support, and maintain contact for about 12 weeks. The goal of this study is to evaluate the outcomes and feasibility of this navigation intervention. Findings will help determine whether a larger study should test if this approach improves access to care and health outcomes for patients with kidney stones.

DISS vs FANS in Suction-Assisted RIRS for Medium-Sized Renal Stones

Kidney stones are a common health problem and may recur frequently, which can affect quality of life and kidney function. Retrograde intrarenal surgery (RIRS) is a minimally invasive treatment used for renal stones, but treatment of medium-sized stones may be associated with longer operative time, impaired visibility during surgery, residual stone fragments, and postoperative infectious complications caused by increased intrarenal pressure. Suction-assisted retrograde intrarenal surgery (RIRS) techniques have been developed to improve surgical efficiency and safety by facilitating continuous removal of stone fragments and helping control intrarenal pressure. Two commonly used suction-assisted approaches are direct in-scope suction (DISS) and flexible and navigable suction ureteric access sheath (FANS). However, there is limited prospective randomized evidence directly comparing these two techniques. This randomized prospective clinical study aims to compare direct in-scope suction (DISS) versus flexible and navigable suction ureteric access sheath (FANS) in adult patients with medium-sized renal stones measuring 2 to 3 cm who are undergoing retrograde intrarenal surgery (RIRS). Participants will be randomly assigned to one of the two suction-assisted techniques. The study will evaluate whether flexible and navigable suction ureteric access sheath (FANS) provides better outcomes than direct in-scope suction (DISS) in terms of stone-free rate and postoperative infection rate. The primary outcome is stone-free status assessed by postoperative imaging. Secondary outcomes include operative time, intraoperative visibility, and postoperative complications, particularly infection and urosepsis. The study hypothesis is that suction-assisted retrograde intrarenal surgery (RIRS) using the flexible and navigable suction ureteric access sheath (FANS) technique will result in a higher stone-free rate and a lower postoperative infection rate compared with direct in-scope suction (DISS) in the management of medium-sized renal stones.

FANS vs CVAC for Medium to Large Stones

Improvements in ureteroscopes have led to improved stone free rates. Two new devices (FANS - Flexible and Navigable Suction) and the CVAC ureteroscope have never been compared head to head. This trial will compare these two new suction ureteroscope technologies against each other

Effect of Negative Pressure Suction on Fluid Absorption and Infection in Flexible Ureteroscopy

The goal of this observational study is to learn about the effects of using negative pressure suction during retrograde intrarenal surgery (RIRS) in patients aged 18 and older with kidney stones. The main questions it aims to answer are: 1. Does using negative pressure suction during surgery affect the amount of irrigation fluid absorbed by the patient's body? 2. Does using negative pressure suction reduce the risk of postoperative infections, such as fever, systemic inflammatory response syndrome (SIRS), and urosepsis? Researchers will compare patients who undergo surgery with a negative pressure suction sheath to patients who undergo surgery with a standard sheath (without suction) to see if the suction technology reduces fluid absorption and lowers the risk of postoperative complications. Participants will undergo their scheduled kidney stone surgery as part of their regular medical care. Researchers will collect their routine clinical data from the hospital system, including: 1. Preoperative test results (such as CT scans, ultrasounds, and urine tests). 2. Intraoperative data (such as surgery duration and the exact amount of fluid absorbed, measured by a monitoring device). 3. Postoperative recovery data (such as body temperature, pain levels, hospital stay length, and any signs of infection).

Stone Clearance With Aspiration vs Other Technologies: a Real-world Evidence Study

The goal of this clinical trial is to evaluate the effectiveness and safety of Steerable Ureteroscopic Renal Evacuation (SURE) with the CVAC System versus other commonly used renal-stone interventions.

The Effect of Apple Cider Vinegar Supplementation on 24-hour Urine Chemistry in Adults

This is a single-center prospective cohort study to evaluate the effect of short-term daily apple cider vinegar (ACV) supplementation on urine chemistry.

Pilot Study to Evaluate the Contribution of Gene Variants to Idiopathic Urolithiasis

Recent investigations from this group have identified that genetic variants of genes associated with monogenic forms of nephrolithiasis are expressed in idiopathic calcium oxalate kidney stone patients and could influence stone forming risk. Utilizing patient samples from the Mayo Clinic Florida Kidney Stone Registry, we will demonstrate that expression of these heterozygous mutations in idiopathic nephrolithiasis act as genetic modifiers of disease presentation increasing risk of kidney stone formation. Complimented by the analysis of environmental and lifestyle risk factors, these studies will define environmental and genetic susceptibility factors involved in kidney stone formation and reoccurrence.

Dual Approach External Oblique Fascial Plane Block Versus Erector Spinae Plane Block for Post Operative Analgesia in Percutaneous Nephrolithotomy

Here is a \*\*patient-friendly, ClinicalTrials.gov-compliant Brief Summary\*\* written in \*\*plain language\*\*, avoiding technical jargon as much as possible while remaining accurate. You can \*\*copy-paste this directly\*\* into the \*\*Brief Summary\*\* field. * \*\*Brief Summary\*\* Percutaneous nephrolithotomy (PCNL) is a common surgical procedure used to remove large kidney stones. Patients often experience moderate to severe pain after this surgery due to the surgical incision and irritation of the kidney and surrounding tissues. Effective pain control after PCNL is important to improve patient comfort, reduce the need for opioid medications, and enhance recovery. Several regional anesthesia techniques have been developed to reduce postoperative pain. Two of these techniques are the dual-approach external oblique fascial plane block and the erector spinae plane block. Both techniques involve injecting a local anesthetic near specific muscle planes using ultrasound guidance to reduce pain signals from the surgical area. However, it is not yet clear which of these two techniques provides better pain relief after PCNL. This study aims to compare the effectiveness of the dual-approach external oblique fascial plane block and the erector spinae plane block in controlling pain after PCNL surgery. Adult patients scheduled for PCNL will be randomly assigned to receive one of the two nerve block techniques or standard general anesthesia alone. Pain levels, additional pain medication requirements, patient satisfaction, and any block-related complications will be assessed during the first 24 hours after surgery. The results of this study may help determine the most effective regional anesthesia technique for improving postoperative pain management in patients undergoing PCNL.

FANS-Assisted Mini-PCNL for Complex Renal Stones

This prospective pilot study aims to evaluate the feasibility, safety, and preliminary clinical outcomes of a novel mini-percutaneous nephrolithotomy (mini-PCNL) technique integrating a flexible mini-nephroscope with a flexible and navigable suction access sheath (FANS) for the treatment of complex renal stones. Thirty consecutive patients with renal stones ≥2 cm will be prospectively enrolled. All patients will undergo FANS-assisted mini-PCNL. The primary outcome is the immediate stone-free rate assessed by non-contrast CT within 72 hours after surgery. Secondary outcomes include operative parameters, postoperative pain, complications, length of hospital stay, and quality of life. This pilot study is designed to provide preliminary evidence supporting the feasibility and safety of FANS-assisted mini-PCNL and to inform the design of future larger-scale studies.

SGLT2i in Kidney Stones

This study is looking at whether empagliflozin, a medication typically used for diabetes and heart conditions, may affect factors that contribute to kidney stone formation. The research focuses on people who have had calcium-based kidney stones, i.e. calcium oxalate or calcium phosphate stones. Previous studies in those without kidney stones found that empagliflozin increased urinary citrate levels without raising urine pH. The investigators are testing whether similar effects occur in people with a history of kidney stones. Participants will take empagliflozin daily for 4 weeks. The investigators will collect 24-hour urine samples before and after treatment to measure various factors that influence stone formation, including citrate levels, pH, and calculated stone formation risk. The investigators will enroll 32 participants: 16 with a history of calcium oxalate stones and 16 with calcium phosphate stones. Results from this study may inform future larger clinical trials investigating empagliflozin as a kidney stone prevention strategy.

Surgical Outcomes and Costs in Using the Shenzhen HugeMed 6.3 French Flexible Ureteroscope

Comprehensive comparative investigations between HugeMed HU30M 6.3 Fr f-URS and traditional approach f-URS devices in RIRS are lacking in an American population. The investigators aim to compare the outcomes of using the 6.3 Fr f-URS versus traditional approach (other f-URS present in our institution) to treat patients with stone burden ≤ 2.5 cm. The findings of this study will expand on the potential advantages and drawbacks of HU30M in enhancing surgical outcomes and patient safety in RIRS procedures. We hypothesize that the use of the HU30M will result in increased cost savings while providing similar stone free rates when compared to traditionally used f-URS devices.

PMCF Investigation of MODULITH® SLX-F2 With StorM-Track in Patients With Kidney Stones

Extracorporeal shockwave lithotripsy (ESWL) is a non-invasive standard treatment for kidney stones. This study will be conducted to evaluate the effectiveness of ESWL using MODULITH® SLX-F2 with stone tracking, compared to MODULITH® SLX-F2 without stone tracking, in adult patients with kidney stones, as measured by stone-free status.

Eye Gaze Guidance Evaluation in Phantoms

This project aims to develop an augmented reality (AR) tool to enhance skill acquisition for endoscopic kidney stone surgery. Of the 100,000 patients who undergo an endoscopic kidney stone treatment annually in the United States, 25% will require a repeat stone surgery within 20 months of their index surgery. The repeat stone surgery rate is almost completely driven by postoperative residual stone fragments, which lead to ureteral obstruction, causing pain, urinary tract infection, and kidney injury. One significant factor that contributes to residual stone fragments is limited visualization of the entire collecting system - a skill directly associated with surgeon experience. This leads to novice surgeons having a much higher recurrence rate than experienced ones. As the incidence of kidney stone disease continues to increase (prevalence of 10%, incidence of 1116 per 100,000), improved endoscopic surgical training is required to improve outcomes of stone surgeries and minimize complications by improving stone-free rate. Currently, skill assessment during endoscopic stone surgery is limited. There are no objective metrics for endoscopic surgery to assess skill. The only feedback trainees get is in the form of verbal communication from expert surgeons, usually after the conclusion of surgery. Thus, most feedback is synoptic and limited in facilitating skill acquisition. Operative time and patient safety concerns restrict the amount of active, real-time feedback given during a case for skill acquisition. Endoscopic kidney stone surgery is uniquely challenging given the small depth and field of view of current endoscopes, which complicate the complete visualization of the entire collecting system. Navigation of the collecting system relies on mentally mapping preoperative imaging to the endoscopic surgical field. Success in mapping relies on hand-eye coordination, memory, and spatial reasoning, which are gained through practice. Thus, there is a need for tools that facilitate endoscopic surgical skill acquisition. The overarching hypothesis for this research is that surgical skill acquisition and outcomes for endoscopic kidney stone surgery can be improved by analyzing eye gaze data and using expert gaze to guide surgical trainees intraoperatively. Eye gaze guidance has been shown to lead to better skill acquisition in virtual reality surgical tasks compared with motion guidance alone. The proposed system would provide real-time education for trainees during endoscopic stone surgery, such as through head-mounted displays (i.e., the Microsoft HoloLens 2). The investigators have previously demonstrated eye gaze sharing in phantoms. By implementing this system in the operating room (OR), the investigators would be able to instill durable skill acquisition in trainees. The investigators will also implement the NASA-task load index for the trainees to gauge the usability of the system.

Ultrasound Imaging of Kidney Stones and Lithotripsy

The purpose of this study is to determine whether new software processing of ultrasound images can improve detection and size determination of kidney stones.

Comparing Efficiency and Stone-Free Rates Mini PCNL vs Flex URS

The objective of the study is to compare the stone free rates with ureteroscopy utilizing the ClearPETRA suction ureteral access sheath, and mini-PCNL; both procedures and ClearPETRA sheaths are standard of care and are used regularly for stone treatment. Our primary objective is to assess the complete stone free rate with both procedures.

Evaluation of Eye Gaze Sharing in the Operating Room

This project aims to develop an augmented reality (AR) tool to enhance skill acquisition for endoscopic kidney stone surgery. Of the 100,000 patients who undergo an endoscopic kidney stone treatment annually in the United States, 25% will require a repeat stone surgery within 20 months of their index surgery. The repeat stone surgery rate is almost completely driven by postoperative residual stone fragments, which lead to ureteral obstruction, causing pain, urinary tract infection, and kidney injury. One significant factor that contributes to residual stone fragments is limited visualization of the entire collecting system - a skill directly associated with surgeon experience. This leads to novice surgeons having a much higher recurrence rate than experienced ones. As the incidence of kidney stone disease continues to increase (prevalence of 10%, incidence of 1116 per 100,000), improved endoscopic surgical training is required to improve outcomes of stone surgeries and minimize complications by improving stone-free rate. Currently, skill assessment during endoscopic stone surgery is limited. There are no objective metrics for endoscopic surgery to assess skill. The only feedback trainees get is in the form of verbal communication from expert surgeons, usually after the conclusion of surgery. Thus, most feedback is synoptic and limited in facilitating skill acquisition. Operative time and patient safety concerns restrict the amount of active, real-time feedback given during a case for skill acquisition. Endoscopic kidney stone surgery is uniquely challenging given the small depth and field of view of current endoscopes, which complicate the complete visualization of the entire collecting system. Navigation of the collecting system relies on mentally mapping preoperative imaging to the endoscopic surgical field. Success in mapping relies on hand-eye coordination, memory, and spatial reasoning, which are gained through practice. Thus, there is a need for tools that facilitate endoscopic surgical skill acquisition. The overarching hypothesis for this research is that surgical skill acquisition and outcomes for endoscopic kidney stone surgery can be improved by analyzing eye gaze data and using expert gaze to guide surgical trainees intraoperatively. Eye gaze guidance has been shown to lead to better skill acquisition in virtual reality surgical tasks compared with motion guidance alone. The proposed system would provide real-time education for trainees during endoscopic stone surgery, such as through head-mounted displays (i.e., the Microsoft HoloLens 2). The investigators have previously demonstrated eye gaze sharing in phantoms. By implementing this system in the operating room (OR), the investigators would be able to instill durable skill acquisition in trainees. The investigators will also implement the NASA-task load index for the trainees to gauge the usability of the system.

Comparison of Vacuum-Assisted and Conventional Ureteral Access Sheath in Retrograde Intrarenal Surgery

This study aims to compare the efficacy and safety, the ratio of stone-free rates, and complications of two types of access sheaths used in retrograde intrarenal surgery to treat upper urothelial stones. The access sheath types are those with vacuum aspiration and the conventional ones.

CaOx Stone Prevention

This single-center randomized controlled trial at Mount Sinai West will enroll 80 patients undergoing percutaneous nephrolithotomy for calcium oxalate stones. Participants will be randomized to receive either empiric therapy or selective therapy guided by 24-hour urine evaluation. The primary outcome is change in calcium oxalate supersaturation at 4 weeks, aiming to determine whether empiric therapy can provide outcomes comparable to selective therapy while simplifying access to prevention.

A Retrospective, Multi-center Real-world Study of Steerable Ureteroscopic Renal Evacuation (SURE) Procedure With the CVAC® System

This is a retrospective, multi-center collaboration to assess real-world outcomes of a novel steerable aspiration system, the CVAC® System ("CVAC"), and flexible and navigable suction ureteral access sheath (FANS) for the treatment of urinary stones.

The LARC Robot Simplifies Renal Access In Percutaneous Nephrolithotomy

This study is being done to evaluate a new robotic system that helps urologists more precisely reach the kidney during surgery to remove large kidney stones. The procedure, called percutaneous nephrolithotomy (PCNL), is typically used for people who have large or difficult-to-remove kidney stones. Traditionally, many urologists rely on radiologists to place a tube into the kidney before surgery. This can cause delays, require multiple procedures, and increase costs. The robotic system being studied - called LARC - is designed to help the urologist safely and accurately guide a needle directly into the kidney during the surgery, without needing a separate procedure beforehand. The robot uses live X-ray images to help align the instruments. Although parts of the robot have been approved by the U.S. FDA, the version used in this study is still investigational and not yet approved for this specific purpose. The study will take place at AdventHealth Celebration and include up to 45 adult patients who are scheduled for PCNL surgery. Participants will be followed for up to 1 month after surgery, and doctors will look at outcomes such as the success of the procedure, the number of kidney stones removed, complications, time in surgery, and radiation exposure. This research may help make kidney stone surgery safer, faster, and more effective in the future.

Flexible Ureteroscopy Versus Extracorporeal Shock Wave Lithotripsy

To compare the efficacy and safety of flexible ureterorenoscopy (fURS) versus extracorporeal shock wave lithotripsy (ESWL) in managing lower calyceal renal stones ≤15 mm and \<1000 HU.

Trial of Ureteroscopy vs Steerable Continuous Flow Aspiration Technology

The goal of this clinical trial is to compare Steerable Ureteroscopic Renal Evacuation (SURE) using the CVAC System and standard ureteroscopy (URS) with laser lithotripsy for the treatment of urolithiasis. This is a prospective, randomized (1:1), multi-center study.

VISOR Versus PCNL for Treatment of 2-4cm Renal Stones

The goal of this clinical trial is to learn if the Vortex Intelligence Stone Optimized Removal (VISOR) works safely and effectively to treat kidney stones that are 2 to 4 centimeters in size in kidney. This study will also look at how VISOR compares to the standard surgery, percutaneous nephrolithotomy (PCNL). The main questions it aims to answer are: How many participants are stone-free within 24 hours after surgery? How many participants are stone-free 1 month after surgery? What side effects or problems, such as pain, fever, or ureter injury, happen with VISOR compared to PCNL? Does VISOR help keep kidney pressure stable during surgery? Researchers will compare VISOR to PCNL to see which treatment works better and is safer. Participants will: Be randomly assigned to have surgery with either VISOR or PCNL. Have imaging tests, such as CT scans or ultrasound, after surgery to check if stones were cleared. Return for follow-up visits about 2 weeks and 1 month after surgery to check recovery and repeat imaging. About 170 people will take part in this study at cooperative hospitals.