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:
2025-12-24 @ 1:42 PM
Ignite Modification Date:
2025-12-24 @ 1:42 PM
NCT ID:
NCT01848795
Eligibility Criteria:
Inclusion Criteria:
* Adults (18-60 year old)
* Type 2 Diabetes diagnosed less than 10 years ago
* Obesity (BMI \> 30)
Exclusion Criteria:
* pregnancy
* inflammatory bowel disease
* peptic ulcer
* gastrointestinal disease preventing device positioning
* pancreatitis,
* coronary artery disease
* symptomatic pulmonary disease
* infection at the time of device placement,
* high risk of gastrointestinal bleeding (coagulopathy, bleeding diathesis, anti-coagulant therapy, Non-Steroid Anti-Inflammatory Drugs)
* altered GI anatomy that could affect device placement
* contraindication of positioning of the devices as per technical description of the producer
* C-peptide negative diabetes
* failure to understand the study protocol or not willing to undergo planned follow-up
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT01848795
Study Brief:
Protocol Section:
NCT01848795