Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:32 AM
Ignite Modification Date:
2025-12-25 @ 3:32 AM
NCT ID:
NCT06376305
Eligibility Criteria:
Inclusion Criteria:
* Moderate OSA on CPAP fulfilling NICE criteria for CPAP(AHI between 15 and 29 with symptoms)
* Prediabetes(HbA1c between 42 \& 48 mmol/mol) or confirmed type 2 diabetes (HbA1C≥48mmol/mol)
* Obesity BMI ≥30 and ≤45 Kg/m2
* Age ≥ 18 years
* Capable of giving informed consent
Exclusion Criteria:
* Abnormal intestinal anatomy
* Contraindication to oesophagogastroduoenoscopy
* Previous bariatric surgery or bowel surgery
* Active infection
* Anticoagulation therapy
* Coagulopathy INR \>1.3
* Estimated Glomerular Filtration Rate (eGFR)\<30
* Known portal hypertension
* Uncontrolled cardiovascular disease
* Lactating or pregnant females
* Excess anaesthetic risk
* Patients taking non-steroidal anti-inflammatory agents will need to discontinue these for the duration of Endobarrier implantation
* Patients taking aspirin/clopidogrel with active ischaemic heart disease or cerebrovascular disease(secondary prevention)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06376305
Study Brief:
Protocol Section:
NCT06376305