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 @ 10:46 PM
Ignite Modification Date:
2025-12-24 @ 10:46 PM
NCT ID:
NCT03160469
Eligibility Criteria:
Inclusion Criteria:
all patients underwent elipse insertion from July 2016 to January 2017with:
* BMI 27-40
* Age 18-65
* Failed multiple diet attemps
* Motivated with realistic weight loss expectations, ready and committed to follow a physician-guided weight-loss program.
Exclusion Criteria:
* Patients with psychologically-driven eating disorders (e.g. binge eating, bulimia, etc.)
* Patients with a history of abdominal and/or pelvic surgery EXCLUDING only ONE of the following surgeries that was performed at least 12 months prior to the Elipse™ Treatment: cesarean section, diagnostic laparoscopy, laparoscopic appendectomy, laparoscopic cholecystectomy.
* Patient has had previous bariatric or gastric surgery.
* Patient has a history of acute pancreatitis.
* Patient has a history of small bowel obstructions.
* Patient has history of/or signs and/or symptoms of esophageal, gastric, or duodenal disease including but not limited to hiatal hernias \>2 centimeter (cm), inflammatory diseases, cancer, and varices.
* Patients with an abnormal swallowing mechanism.
* Patients with a history of cancer, inflammatory disease, bleeding or other disorder of the gastrointestinal (GI) tract.
* Women who are pregnant or breast feeding.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT03160469
Study Brief:
Protocol Section:
NCT03160469