Endoscopic Metabolic and Bariatric Therapies

Enrolling by invitationOBSERVATIONAL
Enrollment

5,000

Participants

Timeline

Start Date

July 8, 2022

Primary Completion Date

July 8, 2026

Study Completion Date

December 31, 2026

Conditions
ObesityObesity, MorbidObesity Associated DisorderBariatric Surgery CandidateFistula, GastricRoux-en-y Anastomosis SiteUlcer, GastricAbdominal PainAbdominal ObesityComplication of Surgical ProcedureComplication of TreatmentComplication,PostoperativeWeight GainWeight LossLeak, AnastomoticDelayed 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.

Trial Locations (1)

02115

Brigham and Women's Hospital, Boston

All Listed Sponsors
lead

Christopher C. Thompson, MD, MSc

OTHER