A UK Registry for Metabolic and Bariatric Endoscopic Interventions

RecruitingOBSERVATIONAL
Enrollment

300

Participants

Timeline

Start Date

February 1, 2024

Primary Completion Date

February 1, 2034

Study Completion Date

February 1, 2039

Conditions
ObesityDiabetes Mellitus, Type 2
Interventions
DEVICE

Endoscopic gastric suturing

Endoscopic suturing of the stomach to reduce volume and promote weight loss with either the Apollo Overstitch or Overstitch Sx system.

DEVICE

Endoscopic gastric plication

Endoscopic plication of the stomach to reduce volume and promote weight loss with either the POSE or Endomina system.

DEVICE

Revisional gastroplasty

Endoscopic suturing or plication of the stomach among patients who have previously undergone gastroplasty, sleeve gastrectomy, or Roux-en-Y gastric bypass to restrict the stomach and promote weight loss

DEVICE

Transoral outlet reduction endoscopy (TORe)

Reduction of the size of the gastro-jejunal anastomosis among patients who have previously undergone Roux-en-Y gastric bypass to promote weight loss. A variety of techniques may be used alone or in isolation including suturing (Apollo Overstitch), plication (POSE), argon photocoagulation, and endoscopic submucosal resection/dissection.

DEVICE

Duodenal mucosal resurfacing (DMR)

Endoscopic ablation of the post-ampullary duodenal mucosal to enhance improvement in glycaemic control among patients with type 2 diabetes.

DEVICE

Intragastric balloon(s)

The insertion of an intragastric implant into the stomach, which is subsequently filled with air or water to promote weight loss. Several intragastric balloons are available including Allurion, Heliosphere, Obalon, Orbera, and Spatz.

Trial Locations (1)

SW1X 7HY

RECRUITING

Cleveland Clinic London, London

All Listed Sponsors
lead

Cleveland Clinic London

OTHER

NCT06305208 - A UK Registry for Metabolic and Bariatric Endoscopic Interventions | Biotech Hunter | Biotech Hunter