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 @ 1:27 AM
Ignite Modification Date:
2025-12-25 @ 1:27 AM
NCT ID:
NCT01429194
Eligibility Criteria:
Inclusion Criteria:
1. Subject, male or female, is age 18 to 50 years of age.
2. Subject must be able to understand and be willing to sign an informed consent document.
3. Subject must be willing and able to participate in all aspects of the study and agree to comply with all study requirements for the duration of the study. This includes availability of reliable transportation and sufficient time to attend all follow-up visits.
4. Subject has a BMI of 40 - 45 or 30 to 39.9 plus one or more co-morbid diseases expected to improve with weight loss, including but not limited to hypertension, dyslipidemia, obstructive sleep apnea, or diabetes mellitus.
5. Subject must be fully ambulatory, without chronic reliance on walking aids such as crutches, walkers or a wheelchair.
6. Subject must be of sufficient and stable medical health, as evaluated by the Principal Investigator.
7. Subject must have a primary care physician that will manage the subject for any co-morbid conditions throughout the study.
8. Subject must have failed standard obesity therapy of diet, exercise, behavior modification, and pharmacologic agents either alone or in combination, as assessed by an interview with a member of the study team at baseline.
9. Subject agrees to refrain from any type of reconstructive surgery that may affect body weight such as mammoplasty or abdominal lipoplasty or liposuction, during the trial.
Exclusion Criteria:
1. Subject has history of/or signs and/or symptoms of gastro-duodenal ulcer disease.
2. Subject has poorly controlled diabetes as indicated by the lack of stable diabetes medications and doses over the last month, or has a history of diabetes for greater than 10 years.
3. Subject has had significant weight loss in the last 3 months, or between baseline and the study procedure.
4. Subject has a history or is diagnosed with eating disorders.
5. Subject has history of peptic ulcer and tests positive for H. pylori, unless treated before the procedure.
6. Subject has symptomatic congestive heart failure, cardiac arrhythmia or unstable coronary artery disease.
7. Subject has pre-existing respiratory disease such as chronic obstructive pulmonary disease (COPD), pneumonia or cancer.
8. Subject has significant esophageal disease including Zenker's diverticulum, grade 3-4 reflux esophagitis, stricture, Barrett's esophagus, esophageal cancer, esophageal diverticulum, dysphagia, achalasia, or symptoms of dysmotility.
9. Subject is observed during EGD to have heavily scarred, malignant or poor quality/friable tissue in areas of the stomach where plications are to be placed.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT01429194
Study Brief:
Protocol Section:
NCT01429194