A UK Registry for Metabolic and Bariatric Endoscopic Interventions

Summary

In the UK alone, obesity is a major health problem with more than one quarter of adults estimated to be obese. Obesity promotes the development of many serious diseases including diabetes, heart disease, kidney disease, and increased risk of some cancers. Patients living with obesity also suffer from significant symptoms that impact their life including shortness of breath, back pain, poor mobility, and poor mental health. Traditional methods to help lose weight include low calorie diets and increased exercise. These may be effective in the short-term, but due to powerful biological mechanisms they are hard to maintain over the long-term and most individuals are unable to achieve normal weight. This means many people may need bariatric surgery that is highly effective at lowering body weight, but it is associated with complications and not all patients will want or be able to undergo surgery. This has led to the development of many new obesity treatments that are completed with an endoscope. An endoscope is a thin flexible tube that has a camera at the end. It is inserted through the mouth and into the stomach and small bowel. There are various procedures that can be done at the time of endoscopy that have been shown to be effective with a low number of side-effects. These are still relatively new compared to more traditional treatments and only a small number of doctors can perform them within the UK. Due to these limitations, the aim of this registry is to obtain real-world information on the safety and effectiveness of these procedures across the UK. The investigators hope over time this will improve the knowledge of clinicians about treating obesity with endoscopy and support future access and funding to these treatments.

Conditions

• Obesity
• Diabetes 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.

Sponsors & Collaborators

• Cleveland Clinic London

  lead OTHER

Principal Investigators

• Rehan Haidry, MD · Cleveland Clinic London

Eligibility

Min Age

18 Years

Max Age

99 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-02-01

Primary Completion

2034-02-01

Completion

2039-02-01

Countries

• United Kingdom

Study Locations