NCT05725967

Endoscopic Metabolic and Bariatric Therapies

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 5,000 (estimated)
• Sponsor: Christopher C. Thompson, MD, MSc · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The Investigators will be collecting data on bariatric patients post-bariatric surgery, post-endoscopic revision of bariatric surgical complications and post-endoscopic metabolic and bariatric therapies (including but not limited to roux-en-y gastric bypass, sleeve gastrectomy, laparoscopic adjustable gastric banding, gastroplasty with endoscopic myotomy (GEM), endoscopic sleeve gastroplasty (ESG), transoral outlet reduction (TORe), primary obesity surgery endoluminal (POSE), restorative obesity surgery endoluminal (ROSE), intragastric balloons (IGB), aspiration therapy and pylorus sparing antral myotomy) to review demographics, adverse events, medications, radiology, procedure time, cost, comorbidity resolution and resource utilization.

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

Type	Name	Description
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.

Timeline

• Start date: 2022-07-08
• Primary completion: 2028-05-28
• Completion: 2029-05-28
• First posted: 2023-02-13
• Last updated: 2025-12-02

Locations

1 site across 1 country: United States