Endoscopic Metabolic and Bariatric Therapies
NCT05725967 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 5000
Last updated 2025-12-02
Summary
This is a prospective collection of data from adult patients who have had an endoscopic metabolic and bariatric endoscopy procedure (EMBT) for primary or revision surgical procedures for obesity.
Conditions
- Obesity
- Obesity, Morbid
- Obesity Associated Disorder
- Bariatric Surgery Candidate
- Fistula, Gastric
- Roux-en-y Anastomosis Site
- Ulcer, Gastric
- Abdominal Pain
- Abdominal Obesity
- Complication of Surgical Procedure
- Complication of Treatment
- Complication,Postoperative
- Weight Gain
- Weight Loss
- Leak, Anastomotic
- Delayed Gastric Emptying Following Procedure
Interventions
- PROCEDURE
-
Primary Obesity Endoscopic Procedures
Any primary endoscopic procedure for treatment of obesity including endoscopic sleeve gastroplasty (ESG), intragastric balloons (IGB), Aspiration therapy, pylorus sparing antral myotomy (PSAM), primary obesity surgery endoluminal (POSE), gastroplasty with endoscopic myotomy (GEM).
- PROCEDURE
-
Endoscopic Revision of Bariatric Surgical Procedures
Any endoscopic revision procedure in a post-bariatric surgical patient, including transoral outlet reduction (TORe), restorative obesity surgery endoluminal (ROSE), argon plasma coagulation of the outlet (APC), endoscopic suturing.
- PROCEDURE
-
Bariatric Surgery Procedures
Any bariatric surgical procedure including Roux-en-Y gastric bypass (RYGB), laparoscopic sleeve gastroplasty (LSG), laparoscopic adjustable gastric banding (LAGB)
- DEVICE
-
Endoscopic Sleeve Gastroplasty, Trans-oral Outlet Reduction
Any endoscopic procedure using an endoscopic suturing device for primary obesity treatment or revision of post bariatric complications.
- DEVICE
-
Intragastric Balloon
An endoscopic bariatric procedure involving the placement of an intragastric balloon.
- DEVICE
-
Primary obesity surgery endoluminal, Restorative obesity surgery endoluminal
Any endoscopic procedure using an endoscopic plicating device for primary obesity treatment or revision of post bariatric complications.
- DEVICE
-
Argon Plasma Coagulation, Gastroplasty with Endoscopic Myotomy, Bariatric Endoscopic Antral Myotomy, Pylorus Sparing Antral Myotomy
Electrosurgical interventions for obesity. Use of electrosurgical devices, such as electrocautery for the primary treatment of obesity or obesity related complications.
- DEVICE
-
Aspiration Therapy
Placement of an aspiration therapy device for the treatment of obesity.
Sponsors & Collaborators
-
Christopher C. Thompson, MD, MSc
lead OTHER
Principal Investigators
-
Christopher C. Thompson, MD, MSc · Brigham and Women's Hospital
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-07-08
- Primary Completion
- 2028-05-28
- Completion
- 2029-05-28
Countries
- United States
Study Locations
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