A UK Registry for Metabolic and Bariatric Endoscopic Interventions
Recruiting · NCT06305208 · Observational (researchers observe without assigning treatment) · Lead sponsor: Cleveland Clinic London
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- Any patient undergoing a primary or revisional bariatric or metabolic endoscopic procedure.
- Age ≥ 18 years old
- Able to give written informed consent.
Exclusion criteria
- 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.
Where it is running
1 location listed.
- Cleveland Clinic London - London, United Kingdom