Endoscopic Metabolic and Bariatric Therapies (EMBTs)

Christopher C. Thompson, MD, MSc

Status: Invitation-only

Conditions: Weight Loss; Roux-en-y Anastomosis Site; Abdominal Obesity; Bariatric Surgery Candidate; Obesity; Obesity Associated Disorder; Fistula, Gastric; Leak, Anastomotic; Obesity, Morbid; Complication of Surgical Procedure; Weight Gain; Complication of Treatment; Complication,Postoperative; Ulcer, Gastric; Delayed Gastric Emptying Following Procedure; Abdominal Pain

Treatments: Device: Intragastric Balloon; Procedure: Endoscopic Revision of Bariatric Surgical Procedures; Device: Argon Plasma Coagulation, Gastroplasty with Endoscopic Myotomy, Bariatric Endoscopic Antral Myotomy, Pylorus Sparing Antral Myotomy; Device: Primary obesity surgery endoluminal, Restorative obesity surgery endoluminal; Device: Aspiration Therapy; Procedure: Primary Obesity Endoscopic Procedures; Procedure: Bariatric Surgery Procedures; Device: Endoscopic Sleeve Gastroplasty, Trans-oral Outlet Reduction

Study type: Observational

Funder types: Other

Identifiers

NCT05725967

2022P001757

Details and patient eligibility

About

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.

Full 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.

Enrollment: 5,000 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients from Mass General Brigham
• any patient having an endoscopic primary obesity procedure
• any patient having an endoscopic post-bariatric surgical revision procedure
• any patient having a bariatric surgical procedure

Exclusion criteria

• patients without past surgical and medical history medical records in the Mass General Brigham system
• patients unwilling to allow for medical record review at Mass General Brigham

Trial design

5,000 participants in 3 patient groups

Primary Obesity Endoscopic Procedures

Description:

Primary endoscopic procedures for treatment of obesity.

Treatment:

Device: Endoscopic Sleeve Gastroplasty, Trans-oral Outlet Reduction

Procedure: Primary Obesity Endoscopic Procedures

Device: Aspiration Therapy

Device: Primary obesity surgery endoluminal, Restorative obesity surgery endoluminal

Device: Argon Plasma Coagulation, Gastroplasty with Endoscopic Myotomy, Bariatric Endoscopic Antral Myotomy, Pylorus Sparing Antral Myotomy

Device: Intragastric Balloon

Endoscopic Revision of Bariatric Surgical Procedures

Description:

Endoscopic revision of post-bariatric surgical complications.

Treatment:

Device: Endoscopic Sleeve Gastroplasty, Trans-oral Outlet Reduction

Device: Primary obesity surgery endoluminal, Restorative obesity surgery endoluminal

Device: Argon Plasma Coagulation, Gastroplasty with Endoscopic Myotomy, Bariatric Endoscopic Antral Myotomy, Pylorus Sparing Antral Myotomy

Procedure: Endoscopic Revision of Bariatric Surgical Procedures

Bariatric Surgery Procedures

Description:

Bariatric surgical procedures.

Treatment:

Procedure: Bariatric Surgery Procedures