ISRCTN16158402Active, not recruitingPhase 2
eft gastric artery embolisation for weight loss in obese patients with BMI 35-50 kg/m²: the EMBIO trial
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Active, not recruiting
- Sponsor
- Imperial College London
- Enrollment
- 76
Study Overview
Brief Summary
2023 Protocol article in https://pubmed.ncbi.nlm.nih.gov/37770263/ (added 29/09/2023)
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1. Adults aged 18-70 years
- •2. BMI 35-50 kg/m²
- •3. Ability to lie supine
- •4. Appropriate anatomy of the left gastric artery and coeliac plexus on CT angiogram
- •5. Willing and able to provide informed consent
Exclusion Criteria
- •1. Haematological, hepatic or renal dysfunction
- •2. Weight >150 kg
- •3. HbA1c >8.5%
- •4. Known renal, vascular or aortic disease
- •5. Malignancy
- •6. Prior major abdominal surgery, prior gastric or bariatric surgery
- •7. Prior abdominal radiotherapy
- •8. Gastrointestinal (GI) bleeding or bleeding diathesis
- •9. Allergy to iodinated contrast,
- •10. Known gastric ulceration or active H. pylori infection
- •11. Positive pregnancy test in females of childbearing age
- •12. Chronic Non-steroidal anti-inflammatory drug (NSAID) use
- •13. Current use of insulin or sulphonylurea
- •14. Current use of anti-tricyclic anti-depressants or steroids
Investigators
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