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NCT06305208Recruiting

A UK Registry for Metabolic and Bariatric Endoscopic Interventions

Source: ClinicalTrials.gov · Last updated 15 Mar 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
300 (estimated)
First submitted
5 Mar 2024
Start date
1 Feb 2024
Primary completion date
1 Feb 2034
Lead sponsor
Cleveland Clinic London
NCT number
NCT06305208

What you commit to

  • Study type: Observational
  • Planned participants: 300
  • From 1 Feb 2024 to the primary completion date, 1 Feb 2034
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

  • 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.

Who the study is looking for

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

Age in the registry: 18 years to 99 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Cleveland Clinic London
Coordinator of this site? Confirm its status
LondonUnited KingdomRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.