Clinical trials: Sleeve Gastrectomy
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.
Surgical Procedure, Unspecified
Comparing the Cost Savings Potential of Orogastric Tubes in Laparoscopic Sleeve Gastrectomy
Comparing the operation times and staple loads used between the use of multiple tubes and a bougie versus a one-step suction callibrated system in laparoscopic sleeve gastrectomy.
- Trial name
- VS1 (NCT03239405)
- Testing
- Suction callibrated system
- Where
- United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Boehringer Labs LLC
Obesity, Type 2 Diabetes Mellitus
Procedure for Duodenal-Ileal Diversion With a Sleeve Gastrectomy for Patients With Obesity and Type 2 Diabetes Mellitus
Study will monitor weight loss and metabolic indicators for subjects in multi-center, single arm trial.
- Trial name
- NCT04627103
- Testing
- Self Forming Magnetic (SFM) Anastomosis System
- Where
- 2 sites in Canada
- Volunteers
- 18 people
- Sponsor
- GI Windows, Inc.
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
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
Morbid Obesity
Early Feasibility for Safety & Device Functionality of SFM Anastomosis Device Used in 3 Procedures (SNAP-S) or (SNAP-PS) or (J-J)
The objectives of this study are to assess the initial safety and device functionality of the SFM Anastomosis System including delivery systems when used to create a duodenal-ileal (D-I) anastomosis either during sleeve…
- Trial name
- GIW-SFM (NCT06199635)
- Testing
- Self-Forming Magnetic Anastomosis Device and Delivery System
- Where
- 2 sites in Chile, India
- Volunteers
- 28 people
- Sponsor
- GI Windows, Inc.
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
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.
Bariatric Surgery Candidate
Retrospective Comparison of Lap and Robotic-Assisted RYGB and SG
A retrospective, multicenter, comparative chart review study comparing laparoscopic and robotic-assisted Roux-en-Y Gastric Bypass (RYGB) and Sleeve Gastrectomy (SG)
- Trial name
- NCT04329780
- Where
- United States
- Volunteers
- 1,872 people
- Sponsor
- Intuitive Surgical
Laparoscopic Sleeve Gastrectomy (LSG), Thoracic Lung Resection Procedure
A Study of ECHELON 3000 (Next Generation Powered Stapler) in General Abdominal and Thoracic Lung Resection Procedures
The purpose of this study is to assess the safety and performance of the ECHELON 3000 Stapler (next generation powered stapler) and reload system in participants undergoing laparoscopic sleeve gastrectomy or lung resection…
- Trial name
- NCT05519215
- Testing
- ECHELON 3000 Stapler
- Where
- 8 sites in United States
- Volunteers
- 244 people
- Sponsor
- Ethicon Endo-Surgery
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.
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
Pain, Postoperative
Gastrectomy at Low Pressure Trial - (GALPT)
The study is designed to compare two different insufflation devices during surgery, CONMED AirSeal to Lexicon, during Laparoscopic Sleeve Gastrectomy.
- Trial name
- GALPT (NCT07313930)
- Testing
- AirSeal® Insufflation System (AIS), Lexicon AP 50/30 Insufflator
- Where
- United States
- Volunteers
- 74 people
- Sponsor
- SurgiQuest, Inc.
Bariatric - Sleeve Gastrectomy Staple Line Reinforcement, Gynecology - Vaginal Cuff Closure
Post-Market Clinical Follow-Up of STRATAFIX™ Spiral PDS™ PLUS
This single-arm, prospective, observational multicenter study will collect clinical data in a post-market setting across two different specialties in Robotic surgical procedures: Bariatric Sleeve gastrectomy (Staple line…
- Trial name
- NCT03937011
- Testing
- Robotic Suturing of gastric sleeve oversew and vaginal cuff closure
- Where
- 8 sites in United States, Germany and 1 more
- Volunteers
- 161 people
- Sponsor
- Ethicon, Inc.
Morbid Obesity
Laparoscopic Sleeve Gastrectomy With Endoscopic Visualization
The main objective of this trial is to evaluate endoscopic visualization during a laparoscopic sleeve gastrectomy (LSG) procedure using an endoscope inserted transvaginally through a new device called a Steerable Flex Trocar…
- Trial name
- NCT00911989
- Testing
- NOTES toolbox
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Ethicon Endo-Surgery
Obesity, Morbid
Procedure for Duodenal-Ileal Diversion for Patients With Weight Regain Following Sleeve Gastrectomy
Study will monitor weight loss and metabolic indicators for subjects in single-center, single arm trial.
- Trial name
- SNAP-PS (NCT05049824)
- Testing
- Self Forming Magnetic (SFM) Anastomosis System
- Where
- Spain
- Volunteers
- 27 people
- Sponsor
- GI Windows, 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
Obesity
Endostapler Sleeve Gastrectomy Study
The goal of this prospective, post-market study is to measure AEON™ Endostapler performance for laparoscopic sleeve gastrectomy surgery versus the Endo GIA™ Reloads with Tri-Staple™ Technology from Medtronic.
- Trial name
- NCT04617574
- Testing
- AEON Endostapler, Endo GIA Reloads with Tri-Staple Technology
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Lexington Medical Inc.