Clinical trials: Sleeve
Obesity
Multi-Center Pre-Bariatric Weight Loss Study
The purpose of the study is to evaluate the safety and efficacy of the GI Sleeve in patients who require weight loss prior to their Bariatric surgery.
- Trial name
- NCT00469391
- Testing
- GI Sleeve Implantable weight loss device (EndoBarrier)
- Where
- 4 sites in United States
- Volunteers
- 56 people
- Sponsor
- Morphic Medical Inc.
Cataract
Evaluation of Performance of New IFIS Sleeve
A silicone sleeve will be used on the hydrodissection needle to avoid that the iris can prolaps through the gap between needle and incision wound.
- Trial name
- NCT06067360
- Testing
- IFIS sleeve
- Volunteers
- 20 people
- Sponsor
- Medicel AG
Hemostasis
A Videographic Study to Evaluate the Impact of a Pulsed Firing Technique on Staple Line Interventions in Laparoscopic Sleeve Gastrectomy
Prospective, multi-center study will evaluate a pulsing technique with the ECHELON FLEX GST system for hemostasis at the staple line in laparoscopic sleeve gastrectomy procedures.
- Trial name
- NCT03896061
- Testing
- Laparoscopic sleeve procedures
- Where
- 3 sites in United States
- Volunteers
- 62 people
- Sponsor
- Ethicon, Inc.
Osteoporotic Fracture of Vertebra
Safety and Efficacy of the ISS Sleeve Augmentation Technique in the Treatment of Thoracolumbar Osteopenic Fractures
Implant anchorage is difficult in patient with osteoporotic bone. To improve the implant bone interface, the ISS stabilization system has been developed.
- Trial name
- NCT04495439
- Testing
- Augmentation with the ISS Study System, Augmentation with PMMA
- Where
- Austria
- Volunteers
- 2 people
- Sponsor
- Nexilis AG
Surgical Procedures, Operative
A Study Comparing ETHICON™ 4000 Stapler System With Standard of Care Stapling Devices in Adults Undergoing Gastric and Thoracic Procedures
The purpose of this study is to compare how well the ETHICON™ 4000 Stapler works as compared to the standard stapling devices by assessing how often air leaks and bleeding along the staple line occur during lung and stomach…
- Trial name
- NCT07744568
- Testing
- ETHICON™ 4000 Stapler System, Standard of Care Stapler and Reloads
- Volunteers
- 300 people
- Sponsor
- Ethicon Endo-Surgery
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
The goal of this clinical trial is to determine whether Endoscopic Sleeve Gastroplasty (ESG)-induced weight loss can improve glycemic outcomes and alter the trajectory toward insulin dependence in adults with obesity and…
- Trial name
- MEASURE (NCT07639684)
- Testing
- ESG with OverStitch
- Volunteers
- 50 people
- Sponsor
- Boston Scientific Corporation
Sleeve Gastrectomy
Powered Handle Primary Sleeve Gastrectomy Study
The objective of this prospective, single arm, single-center study is to evaluate patients who are undergoing primary sleeve gastrectomy procedures and are surgically treated with the AEON Endoscopic Powered Handle Stapler and…
- Trial name
- NCT06474637
- Testing
- AEON Endoscopic Powered Stapler Handle and Reload
- Where
- Lithuania
- Volunteers
- 100 people
- Sponsor
- Lexington Medical Inc.
Parkinson Disease
Performance of the Paragit Sleeve to Measure and Monitor Motor Symptoms in Patients With Parkinson's Disease
This investigation is undertaken to: Evaluate the accuracy and reliability of the device in measuring and recording motor symptoms associated with Parkinson's Disease (PD), and To assess the safety and tolerability of the device…
- Trial name
- PARPIV23 (NCT06490861)
- Testing
- Paragit
- Where
- Spain
- Volunteers
- 25 people
- Sponsor
- Paragit ApS
Hallux Valgus Deformity
Hallux Valgus Correction Surgery Recovery Using Semiconductor Embedded Therapeutic Sleeves
This study is looking to test a non-compressive semiconductor embedded ankle sleeve and sock for post hallux valgus correction surgery rehabilitation.
- Trial name
- NCT07422623
- Testing
- Semiconductor embedded ankle sleeve and sock
- Where
- United States
- Volunteers
- 115 people
- Sponsor
- INCREDIWEAR HOLDINGS, INC.
Type 2 Diabetes
A Study of the GI Sleeve for the Treatment of Type 2 Diabetes
The purpose of the study was to evaluate the safety and efficacy of the EndoBarrier Gastrointestinal Liner compared to sham control in subjects with Type 2 diabetes.
- Trial name
- NCT02709577
- Testing
- EndoBarrier Gastrointestinal Liner
- Volunteers
- 36 people
- Sponsor
- Morphic Medical Inc.
Obesity, Overweight
Comparing the Efficacy and Safety of the EndoZip System and Apollo ESG in Obese Patients
evaluation of the EndoZip system procedure compared to the Apollo ESG procedure in obese patients.
- Trial name
- ESG (NCT07090005)
- Testing
- EndoZip System, OverStitch Endoscopic Suturing System (ESG)
- Where
- 5 sites in United States, Italy
- Volunteers
- 184 people
- Sponsor
- Nitinotes Surgical Ltd.
Intraoperative Staple Line Bleeding as Measured by the Provided Bleeding Severity Scale
Endostapler Hemostasis Study
The goal of this prospective, multi-center, post-market study is to measure AEON™ Endostapler performance with the EASY/THICK MODE feature for laparoscopic bariatric surgery against the Echelon Flex™ Powered Stapler system from…
- Trial name
- NCT04149925
- Testing
- AEON Endostapler, Echelon Flex Powered Stapler
- Where
- 3 sites in United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Lexington Medical Inc.
ECRB Tendinopathy
The Comparison of Semiconductor Embedded Therapeutic Arm Sleeves for the Treatment of ECRB Tendinopathy
This study seeks to identify patient reported and clinically measured outcomes for pain management and elbow function with application of semiconductor embedded fabric combined with PRP+ASC injections in the affected area.
- Trial name
- NCT06846593
- Testing
- Semiconductor Embedded Therapeutic Arm Sleeves, Platelet-Rich Plasma with Adipose Stem Cell (PRP+ASC) Injections
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- INCREDIWEAR HOLDINGS, INC.
Morbid Obesity
Clinical and Economic Outcomes in Laparoscopic Sleeve Gastrectomy Versus Roux-en-Y Gastric Bypass Surgery
Study objectives: 1. generate local clinical, health-related quality-of-life and health economic data to evaluate the benefits of two types of minimally invasive weight-loss surgery 2.
- Trial name
- OPTIMIZE (NCT01754194)
- Testing
- Gastric Sleeve Resection, Roux-en-Y Gastric Bypass
- Where
- 18 sites in Germany
- Volunteers
- 293 people
- Sponsor
- Medtronic - MITG
Lymphedema of Upper Arm
Circaid® Compression Sleeve Versus Short-stretching Bandage in Upper Limb Lymphatic Edema
One of the difficulties encountered in the treatment of lymphedema, both in the active reduction phase and in the maintenance phase, is the appliance of the short-length compression bandages which requires good technicality and…
- Trial name
- NCT03492476
- Testing
- Circaid, Short-stretching Bandage (Reference treatment)
- Where
- 4 sites in France
- Volunteers
- 142 people
- Sponsor
- CEN Biotech
Osteoarthritis, Knee
A Telehealth Study of a Wearable Electroceutical & Sports Sleeve for Knee Osteoarthritis Pain Relief & Improved Function
The purpose of this telemedicine 24-person open-label study is to evaluate the safety and usability of a proprietary wearable microcurrent electroceutical (a device that delivers micro-ampere electronic pulses) made by Healables…
- Trial name
- HEAL01WMCOA1 (NCT04938271)
- Testing
- HEAL-122 microcurrent electroceutical with e-textile sports knee sleeve
- Where
- Israel
- Volunteers
- 24 people
- Sponsor
- Healables Ltd.
Obesity
Evaluation of a Powered Stapler System on Surgical Interventions Required During Laparoscopic Sleeve Gastrectomy
This study will provide clinical data in an observational setting. Individuals undergoing LSG, and who meet study entry criteria, may be enrolled.
- Trial name
- NCT02358785
- Testing
- ECHELON FLEX™ Powered Plus Stapler
- Where
- 4 sites in United States
- Volunteers
- 100 people
- Sponsor
- Ethicon Endo-Surgery
GERD, Gastroesophageal Reflux Disease
RELIEF Europe Study
The purpose of this study is to evaluate the LINX device in patients who have previously undergone laparoscopic sleeve gastrectomy (LSG) for obesity and have chronic gastroesophageal reflux disease (GERD).
- Conditions
- GERD, Gastroesophageal Reflux Disease, Obesity, LSG
- Trial name
- NCT02762487
- Testing
- The LINX® Reflux Management System
- Where
- 4 sites in Germany, Italy
- Volunteers
- 7 people
- Sponsor
- Torax Medical Incorporated
Pain, Postoperative
Comparison of AirSeal to DV5 Insufflation in Gastric Sleeve Procedures - The "CAT5-GS" Study
A study to compare two different insufflation devices during robotic laparoscopic sleeve gastrectomy surgery, AirSeal to DV5 insufflation, in Gastric Sleeve Procedures. Shoulder, neck and chest pain will be assessed.
- Trial name
- "CAT5-GS" (NCT07312006)
- Testing
- AirSeal Insufflation system, DV5 Insufflation system
- Where
- United States
- Volunteers
- 74 people
- Sponsor
- SurgiQuest, Inc.
GERD, Gastroesophageal Reflux Disease
LINX Reflux Management System in Subjects With GERD Who Have Previously Undergone a Laparoscopic Sleeve Gastrectomy
The purpose of this study is to evaluate the LINX device in patients who have previously undergone laparoscopic sleeve gastrectomy (LSG) for obesity and have chronic gastroesophageal reflux disease (GERD).
- Trial name
- RELIEF (NCT02429830)
- Testing
- LINX device
- Where
- 12 sites in United States
- Volunteers
- 30 people
- Sponsor
- Torax Medical Incorporated