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 @ 2:44 AM
Ignite Modification Date:
2025-12-25 @ 2:44 AM
NCT ID:
NCT03576833
Eligibility Criteria:
Inclusion Criteria:
* adults 18 year or older with BMI ≥30 and ≤40 kg/m2, and a diagnosis of type 2 diabetes.
Exclusion Criteria:
1. Symptomatic congestive heart failure, cardiac arrhythmia or unstable coronary artery disease
2. Previous bariatric or gastric surgery
3. History of chronic or acute pancreatitis
4. History of small bowel obstructions
5. History of open abdominal and/or pelvic surgery EXCLUDING open appendectomy with a right lower quadrant incision.
6. Thyroid or adrenal disease not controlled with medication
7. History of/or signs and/or symptoms of esophageal, gastric, or duodenal disease such as dysphagia and/or painful swallowing, hiatal hernias \>5 centimeter, paraesophageal hernias, chronic or acute inflammation, cancer, varices, diverticula, gastroparesis, ulcers, stricture/stenosis, or achalasia
8. Specific diagnosed genetic or hormonal cause for obesity such as Prader-Willi syndrome
9. Severe coagulopathy, hepatic insufficiency or cirrhosis
10. Unable or unwilling to discontinue use of aspirin and/or non-steroidal anti-inflammatory agents (NSAIDs) at least 14 days prior to Elipse deployment and continuing for 14 days after Elipse excretion
11. Anemia defined as either Hgb \<11 g/dL for females and \<12 g/dL for males
12. Inability to walk 200 meters without assistance
13. Eating disorders including night eating syndrome (NES), bulimia, or binge eating disorder
14. Current or history of illicit drug use or excessive alcohol use
15. Currently taking the following medications (within 30 days prior to enrolment) and/or anticipated need for these medications during the study: Systemic corticosteroids; anticoagulants (e.g. warfarin, dabigatran) or anti-platelet therapy; narcotics or opiates; anti-seizure medication (e.g. clonazepam, phenytoin)
16. Serum autoantibodies against glutamic acid decarboxylase (GAD) or tyrosine phosphatase (IA2) (MODY or type 1 diabetes)
17. Any specified conditions that, in the opinion of the investigator, may render the subject unable to complete the study without a likely fatal outcome, or lead to difficulties for subject compliance with study requirements, or could confound study data.
18. Women in childbearing age must document a negative pregnancy test. Women must not be breast-feeding at the time of treatment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT03576833
Study Brief:
Protocol Section:
NCT03576833