Clinical Research Directory

Clinical Outcomes, Safety, and Effectiveness of Speedboat UltraSlim™ in Per-Oral Endoscopic Myotomy (POEM)

This study is a prospective registry designed to evaluate the clinical outcomes, safety, and effectiveness of per-oral endoscopic myotomy (POEM) performed using the Speedboat UltraSlim™ device in patients with achalasia or other esophageal motility disorders. Participants included in this registry are those undergoing clinically indicated POEM as part of standard of care. No experimental interventions will be performed as part of this study. Patients will be approached for participation after the clinical decision to perform POEM has already been made. Data will be collected through review of electronic medical records and procedural documentation, including patient demographics, procedural details, and clinical outcomes. Follow-up data will be collected at predefined time points (e.g., 30 days, 3 months, 6 months, and up to 1 year) to assess symptom improvement, procedural success, and adverse events. The primary objective of the study is to assess technical success, clinical success, and safety outcomes associated with the use of the Speedboat UltraSlim™ device during POEM procedures. This registry poses minimal risk to participants, as all procedures are performed as part of routine clinical care. No additional interventions beyond standard care are required for participation.

Monopolar and Bipolar Current RFA Knife in POEM

Per Oral Endoscopic Myotomy (POEM) is performed for various esophageal muscular disorders, including achalasia and other spastic esophageal conditions. It is performed with the standard endoscope and involves dissecting the esophageal muscle sphincter. The procedure is typically completed using standard monopolar energy, which are effective, but can be associated with post-procedural pain. More importantly, frequent exchange of various instruments are required in order to cut the right layers and to stop bleeding. The Speedboat-RSD is FDA approved for dissection of various tissue within the gastrointestinal tract tract but only a few studies have evaluated its use in POEM. Currently, the investigators have been performing EGD with POEM procedures using Speedboat-RSD as a standard of care procedure. The investigators would like to compare the performance of the standard monopolar ERBE knife to the bipolar Speedboat-RSD knife in POEM. The investigators hypothesize the bipolar knife will allow for efficient completion of the POEM procedure with less post procedural pain.

U-POEM vs CO2-POEM

Multicenter randomized trial comparing post-procedural pain intensity after Per-Oral endoscopic myotomy (POEM) between two types of standard of care insufflation methods (CO2 vs Underwater). POEM is routinely performed under carbon dioxide insufflation (CO2-POEM) as this gas is more rapidly absorbed than air, which has been shown to reduce gas-related complications. Water immersion for luminal distension of the GI tract as opposed to carbon dioxide insufflation has been shown to be associated with improved patient satisfaction, safety profile and even higher detection of polyps during colonoscopy in randomized trials Aim 1. The primary aim is to compare post-procedural pain following U-POEM vs. CO2-POEM. Aim 2. Compare the proportion of patients that require post-procedural admission for pain management. Aim 3. Compare the need for analgesic medications for pain control in patients undergoing U-POEM vs. CO2-POEM. Aim 4. Compare technical and clinical success between U-POEM vs. CO2-POEM. Technical success is defined as successful completion of the procedure whereas clinical success will be defined as an Eckardt score ≤ 3 at the time of follow-up. Aim 5. Compare and evaluate procedural characteristics between the two groups. 1. Compare procedural time between U-POEM and CO2-POEM. 2. Compare the mean number of coagulations with hemostatic forceps for active intraprocedural bleeding and the mean number of times in which a device besides an electrosurgical knife was required for prophylactic ablation of vessels. 3. Adverse event rate (i.e. bleeding, perforation).

Gastrointestinal Dysmotility on Aspiration Risk

The hypothesis of this study is that esophageal and gastric dysmotility increase the risk of developing aspiration-associated symptoms in children with neurologic impairment. The investigators are conducting a ten week cross over study comparing prucalopride to famotidine for the treatment of aspiration-associated symptoms.

High Resolution Manometry After Partial Fundoplication for Gastro-oesophageal Reflux

This is a combined retro- and prospective, monocentric study. All patients who underwent or are planned for laparoscopic partial fundoplication (180° anterior or 270° posterior) between 2020-2023 are assessed for preoperative ineffective esophageal motility (IEM). The main hypothesis is, that preoperative oesophageal motility disorders, especially hypo-contractility or failed peristalsis, are caused by gastro-oesophageal reflux. Therefore, postoperative manometry after partial wrap fundoplication (270° posterior, 180° anterior) shows a decrease in comparison to preoperative motility disorders. The primary objective of this study is to examine the postoperative esophageal motility in patients with known preoperative motility disorders. Secondary endpoints are the presence of other oesophageal motility disorders pre- vs. postoperatively (including new onset disorders), the assessment of the Gastrointestinal Symptom Rating Scale (GSRS) pre- vs. postoperatively, and more. If IEM is present preoperatively, patients are contacted at least 1 year after surgery and will be informed about the study and asked to participate. In case of agreement, they are invited to the study site. They undergo high-resolution manometry 18-24 months postoperatively (study intervention).

Establishing Pressures at the EGJ During Diaphragmatic Breathing Using High-resolution Esophageal Manometry

The goal of this study is to determine which position, maneuvers or combination thereof generates the highest pressure at the EGJ as assessed by high-resolution esophageal manometry and thus greater or more robust contraction of the diaphragm.

Diagnostic Evaluation of Esophageal Motility Disorders Using the Chicago IV Protocol in Egypt

Esophageal motility disorders (EMDs) encompass a spectrum of conditions characterized by abnormal movement and coordination of the esophagus, leading to symptoms such as dysphagia, chest pain, regurgitation, and heartburn . These symptoms can severely impact quality of life, often requiring detailed diagnostic evaluations for appropriate management . High-resolution esophageal manometry (HRM) has emerged as a critical diagnostic tool, providing comprehensive assessments of esophageal motility and improving our understanding of the pathophysiology behind EMDs . The advancements in HRM technology have significantly enhanced diagnostic accuracy, leading to more effective treatment strategies. The Chicago Classification (CC) was introduced to standardize the interpretation of HRM findings and facilitate communication among clinicians. Since its inception in 2009, the classification has undergone several updates to reflect ongoing advancements. The most recent update, Chicago Classification version 4.0 (CC v4.0), resulted from two years of collaboration by an international working group of motility experts . This version places a greater emphasis on clinical relevance, refining diagnostic criteria to include standardized assessments in both the supine and upright positions, as well as the use of provocative maneuvers to provide a more thorough evaluation of esophageal function . These enhancements aim to improve the understanding and diagnosis of complex motility disorders Although CC version 3.0 (CC v3.0) has been widely utilized, it has limitations that CC v4.0 effectively addresses to enhance esophageal motility testing. By requiring assessments in both supine and upright positions, CC v4.0 captures motility abnormalities in more physiologically relevant conditions, The inclusion of provocative testing methods, such as multiple rapid swallows (MRS) and solid swallows, further increases sensitivity for detecting disorders under stress. Moreover, CC v4.0 offers a comprehensive analysis of esophagogastric junction (EGJ) function, introducing criteria for EGJ outflow obstruction and EGJ typing, which clarify interactions with the lower esophageal sphincter . This updated framework also emphasizes bolus transit and metrics for fragmented peristalsis, facilitating the identification of subtle motility issues that may impact bolus clearance In Egypt, the majority of manometric devices are configured to automatically interpret results using CC v3.0, limiting the integration of newer diagnostic criteria. By manually applying CC v4.0 in this study, we seek to determine whether its updated metrics offer enhanced diagnostic precision and a better correlation with clinical symptoms.

Effect of Esophageal Contractile Reserve on Changes in Esophageal Motility and Symptoms After ARS in Patients With GERD

rapid swallow (MRS) can assess the contractile reserve capacity of the oesophageal body and identify and diagnose oesophageal motility disorders, but the impact of preoperative oesophageal reserve capacity on postoperative symptoms and motility in patients with GERD remains unclear. The aim of this study was to assess the effect of pre-operative oesophageal reserve capacity on post-reflux symptoms and motility in patients with GERD by using a high-resolution oesophageal manometry-based provocation test, MRS, to track pre-operative ineffective oesophageal motility (IEM).