A UK Registry for Metabolic and Bariatric Endoscopic Interventions

NCT06305208 | Recruiting DMC

• 1 other identifier: CCLR-23-018
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (3)

• Total body weight loss percentage (TBWL%)

  For primary or revisional bariatric procedures: Percentage weight loss will be calculated using the following formula: TBWL% = \[(weight at the baseline-weight at the end of time period)/weight at baseline\] x 100

  6-months, 1-, 2-, 3-, 5-years

• Change in glycated haemoglobin (HbA1c; mmol/mol)

  For primary metabolic procedures

  6-months, 1-, 2-, 3-, 5-years

• Change in the number and dose of anti-diabetic medications

  For primary metabolic procedures

  6-months, 1-, 2-, 3-, 5-years

Secondary Outcomes (20)

• Procedure time (mins)

  Baseline

• Inpatient stay (days)

  6-months, 1-, 2-, 3-, 5-years

• Adverse events

  30-day, 6-months, 1-, 2-, 3-, 5-years

• Change in systolic blood pressure measurements (mmHg)

  6-months, 1-, 2-, 3-, 5-years

• Change in diastolic blood pressure measurements (mmHg)

  6-months, 1-, 2-, 3-, 5-years

Study Arms (3)

Primary bariatric endoscopic procedures

Device: Endoscopic gastric suturing; Device: Endoscopic gastric plication; Device: Intragastric balloon(s)

Revisional bariatric endoscopic procedures

Device: Revisional gastroplasty; Device: Transoral outlet reduction endoscopy (TORe)

Primary metabolic endoscopic procedures

Device: Duodenal mucosal resurfacing (DMR)

Interventions

Endoscopic gastric suturing DEVICE

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

Also known as: Endoscopic sleeve gastroplasty (ESG; Apollo Overstitch)

Primary bariatric endoscopic procedures

Endoscopic gastric plication DEVICE

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

Also known as: Primary obesity surgery endoluminal (POSE), Endomina system

Primary bariatric endoscopic procedures

Revisional gastroplasty DEVICE

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

Revisional bariatric endoscopic procedures

Transoral outlet reduction endoscopy (TORe) DEVICE

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.

Revisional bariatric endoscopic procedures

Duodenal mucosal resurfacing (DMR) DEVICE

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

Primary metabolic endoscopic procedures

Intragastric balloon(s) DEVICE

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.

Primary bariatric endoscopic procedures

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients within the United Kingdom (UK) who have, or plan to, undergo a primary or revisional bariatric or metabolic endoscopic procedure for the treatment of obesity or metabolic disease in the UK

You may qualify if:

• Any patient undergoing a primary or revisional bariatric or metabolic endoscopic procedure.
• Age ≥ 18 years old
• Able to give written informed consent.

You may not qualify if:

• Any bariatric or metabolic endoscopic procedure performed outside the UK.
• Any bariatric or metabolic endoscopic procedure not currently listed within the registry protocol or agreed by the steering committee.
• Unable to provide written informed consent.

Sponsors & Collaborators

• Cleveland Clinic London: lead

Study Sites (1)

Cleveland Clinic London

London, SW1X 7HY, United Kingdom

RECRUITING

MeSH Terms

Conditions

Obesity; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Study Officials

• Rehan Haidry, MD

  Cleveland Clinic London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Benjamin Norton, MD

CONTACT

+442034237500; cclendoscopyresearch@ccf.org

Fiona Makia

CONTACT

+442034237500; cclresearch@ccf.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2024
• First Posted: March 12, 2024
• Study Start: February 1, 2024
• Primary Completion (Estimated): February 1, 2034
• Study Completion (Estimated): February 1, 2039
• Last Updated: March 15, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)