Clinical Research Directory

Intracoronary Cryotherapy Effect on Stabilization of Vulnerable Plaque in Patients With Stable Angina or ACS - A Traditional Feasibility Study

ICECAP is a multi-centre, prospective, single-arm, interventional, traditional feasibility clinical investigation to evaluate the efficacy and safety of intra-coronary cryotherapy on vulnerable or high-risk plaque (HRP), using the CryoTherapy System (CTS). The study aims to enroll 25 patients with symptomatic coronary artery disease, successfully treated for their culprit lesion and with presence of at least one HRP lesion in another vessel. Eligible patients will undergo cryotherapy during a planned procedure. Near-infrared spectrometry (NIRS and Optical Coherence Tomography imaging will be used during baseline procedure, and during a 9 months follow visit. The primary endpoint is reduction of plaque burden measured as 30% reduction in maxLCBI4mm as measured by NIRS at 9 months post procedure.

Intracoronary Cryotherapy Effect on Stabilization of Vulnerable Plaque in Patients With (N)STEMI or Unstable Angina

The POLARSTAR study is an early safety and feasibility study to evaluate the performance and safety of the CryoTherapy System (CTS) for the treatment of coronary plaque lesions that are not obstructing blood flow but are at high-risk of rupture which would cause a major heart attack. The CTS is used to apply local freezing of the lesion using a balloon catheter, controlled by a console that regulates in- and outflow of a cooling agent into the catheter. The treatment is expected to stabilize the lesion, diminishing the risk of rupture. The study will enrol subjects with acute coronary disease who have suitable coronary lesions. Subjects will be followed for 1 year after the CTS treatment. Baseline identification of lesions will be done using Coronary CT-angiography (CCTA), which will be repeated at 3 and 9 months after procedure.

This Clinical Trial Aims to Compare the Effectiveness of Two Intra-pulpal Cryotherapy Techniques-Endo-ice and Ice Sticks-in Decreasing Intra-operative Pain and Enhancing the Success of Local Anesthesia During Pulpectomy of Mandibular Molars With Symptomatic Irreversible Pulpitis.

The goal of this clinical trail is to compare the analgesic effect of endo-ice and ice-sticks in reducing intra-operative pain during pulpectomy in molars with Symptomatic Irreversible Pulpitis. Principal Investigator will perform the procedure and outcome assessor will interview the participants as well as fill the pre-operative questionnaire. The patient will be instructed beforehand on how to score their pre-operative, intra-operative and post-operative intensity of pain according to Visual Analogue Scale.The Anxiety level of patient will also be recorded according to the Corah's Dental Anxiety Scale questionnaire and their level of anxiety before and after the intervention will be recorded by the outcome assessor. The principal investigator will perform all endodontic procedures, with the outcome assessor blinded to the cryotherapy method. Prior to administering IANB, a topical anesthetic gel will be applied. A 27-gauge needle will deliver 1.8 ml of 2% lidocaine with 1:100,000 epinephrine at a rate of 1 ml/min. After a 5-minute wait, anesthesia effectiveness will be confirmed through electric pulp testing (EPT) on a neighboring tooth, with two consecutive negative responses confirming success. Once adequate anesthesia is confirmed, an access opening will be made under rubber dam isolation for the procedure. 1. CONTROL GROUP: After access opening and complete de-roofing of the pulp chamber, pulpectomy of the inflamed pulp will be performed under the given effective IANB with no additional intervention to control intra-operative pain. 2. ENDO-ICE GROUP: After access opening, pulp will be exposed and de-roofing will be performed. Endo-ice with the help of cotton pellet will be applied inside the pulp chamber for 2min (8 consecutive applications, 15sec each) and pulpectomy of the inflammed pulp will be performed immediately. 3. ICE-STICKS GROUP: Following the access opening and complete de-roofing of pulp chamber, four ice sticks will be placed inside the pulp chamber for 2 minutes (30 seconds each, using tweezer). Subsequently, pulpectomy of the inflamed pulp will be performed immediately. Patients will be asked to rate their level of pain to the outcome assessor at four specific intervals during the trial, i.e., pre-operative (before local anesthesia), pre-operative (after local anesthesia), during pulpectomy and immediately after pulp extirpation and it will be recorded in a proforma by the blinded outcome assessor. Pain and Anxiety Scores will be compared to asses either cryotherapy or which method of cryotherapy found to be effective in reducing intra-operative pain.

Intercostal Nerve Cryotherapy in Patients Undergoing Minimally Invasive Pulmonary Resection

This is a research study designed to test whether a treatment called Intercostal Nerve Cryotherapy is an effective way to help control post-surgical pain for patients undergoing minimally invasive pulmonary resection. There are two treatment groups in this study, a cryotherapy group and control group. Cryotherapy is a method of controlling pain by freezing nerves between the ribs that would transmit pain impulses to the brain.

Cryoablation in Combination (or Not) With Pembrolizumab and Pemetrexed-carboplatin in 1st-line Treatment for Patients With Metastatic Lung Adenocarcinoma

This study aims to compare the one-year survival benefit of the association of cryoablation-pembrolizumab-pemetrexed-carboplatin versus pembrolizumab-pemetrexed-carboplatin in metastatic lung adenocarcinoma patients. This is a multicenter, prospective, open-labeled, 2-arm comparative randomized (1:1) phase III trial. Patients will be randomized with a 1:1 ratio into: * Arm A (experimental arm): cryoablation of one visceral lesion or bone metastasis excluding liver and sclerotic bone metastases combined with pembrolizumab and pemetrexed-carboplatin prescribed as per market authorization. * Arm B (standard arm): pembrolizumab and pemetrexed-carboplatin prescribed as per market authorization. Pembrolizumab and pemetrexed-carboplatin will be prescribed and administered at the dose recommended by market authorization. Cryoablation treatment should be performed within 6 weeks after the first administration of pembrolizumab. No treatment switching permitted.

Utility of Intermittent Cryo-Compression Versus Traditional Icing Following Arthroscopic Rotator Cuff Repair

Effective post - operative pain control following orthopedic surgical procedures without excessive reliance upon opioid pain medication has garnered increased attention in recent years. This study will evaluate the utilization of a non-invasive, novel cryo - compression, post-operative modality to improve pain control versus standard ice wraps in the immediate post-operative phase of arthroscopic rotator cuff surgery via a randomized controlled study design. Furthermore, if this study demonstrates improved pain control, improved quality of life and decreased opioid usage with the intermittent cold compression unit, recommendations may be considered for system-wide utilization.

VibraCool Device to Reduce Pain and Opioid Use After Anterior Cruciate Ligament Reconstruction (ACLR)

The goal of this project is to test the effects of the VibraCool mechanical stimulation neuromodulatory therapeutic device on post-operative pain and opioid use following anterior crucitate ligament reconstruction (ACLR), and thus residual opioids in circulation.

National Registry of Surgical Treatment and Percutaneous Cryoablation of Parietal Endometriosis

National multicentric registry of a cohort of patient with suffering parietal endometriosis, carried out by a multidisciplinary radiosurgery team

Combined Cryotherapy With Compression Versus Cryotherapy Alone After Orthopaedic Surgery

Cryotherapy has been used to enhance recovery after orthopaedic surgery. Many devices are available but few can guarantee a temperature regulation during a prolonged time and therefore have been criticized. The arrival of new advanced cryotherapy devices made it possible to test the effect of prolonged cooling on rehabilitation after arthroscopic orthopaedic procedures.

Percutaneous Intercostal Cryoneuromodulation Onset Timing.

Percutaneous Intercostal Cryoneurolysis is a promising technique that addresses acute postoperative pain after Nuss procedure for pectus excavatum. However its onset timing has not yet been determined. A physical examination would assess the variation of chest skin sensitivity to soft touch, cold (water at 4°C), and heat (water at 40°C) through days following the cryoneurolysis procedure.

Cryoanalgesia and Post-thoracotomy Pain in Minimally Invasive Cardiothoracic Surgery

Minimally invasive cardiothoracic surgery is often associated with chronic pain syndrome, out of keeping with the extent of surgical dissection. This is thought to be because of damage to the intercostal nerves by compression and traction by the surgical equipment. Cryoanalgesia is long-standing technique that freezes nerves locally to temporarily block pain sensation, which is currently used to treat acute post-operative pain in lung dissections and the Nuss procedure. We intend to perform a trial to assess whether using cryoanalgesia on intercostal nerves intraoperatively, reduces post-operative pain following minimally invasive cardiothoracic surgery.

Acute Effects of Cryotherapy on Muscle Properties

The main aim of this study is to investigate the acute effects of cryotherapy on muscle mechanical properties, muscle strength, and activation changes in healthy subjects.

A Cryotherapy With Tranexamic Acid Versus Normal Saline in the Treatment of Melasma

This study aimed to evaluate the effectiveness of a precision cryotherapy via boosting mode combined with tranexamic acid versus normal saline in the treatment of melasma. Eighteen patients aged 25 to 60 years diagnosed with epidermal-typed melasma sized equal to or more than 2 cm on both cheeks were included. The patients were treated with a precision cryotherapy via boosting mode combined with tranexamic acid and normal saline on each side of cheek for 4 times every 1 week. Then, they were follow up at 1 and 3 months after the last treatment. Subjective assessment of physician and patient improvement were evaluated. Moreover, Melasma Area and Severity Index (MASI), melanin and erythema index using Mexameter were also recorded.

Evaluation of Cryotherapy in Granuloma Pyogenicum

Surgical excision needs general anesthesia and might have complications due to anesthesia. Cryotherapy can be used in an outpatient setting and doesn't need general anesthesia. This study will evaluate if cryotherapy works in granuloma pyogenicum with the advancement of no general anesthesia.