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 @ 10:40 PM
Ignite Modification Date:
2025-12-24 @ 10:40 PM
NCT ID:
NCT02183935
Eligibility Criteria:
Inclusion Criteria:
* Subjects estimated to fully comply with study protocol and have signed an informed consent form.
* Age \> 15 years.
* BMI ≥ 99. percentile for age and gender.
* Inefficient conservative measures (of at least 6 months duration) to decrease body weight (characterized as a decrease in BMI \> 10 %).
* Documented negative pregnancy test in women of childbearing potential.
* Women of childbearing potential agree to remain on contraceptives for the duration of their trial participation.
Exclusion Criteria:
* Previous GI surgery that could potentially affect the ability to place sleeve or affect the function of the implant.
* Subjects with congenital or acquired anomalies of the GI tract which in the opinion of the investigator, may impair implantation of the EndoBarrier device.
* Subjects who had gastrooesophageal reflucs disease..
* Known abnormal pathologies or conditions of the gastrointestinal tract, including ulcers or Crohn's disease, upper gastro-intestinal bleeding conditions.
* Coagulopathy defined as Hgb \<10g/dl and platelet \< 100,000/ml or diagnosis of other severe coagulopathy like hemophilia.
* Any documented history of acute or chronic pancreatitis.
* Subjects requiring regular antithrombotic therapy (i.e. anticoagulant or antiplatelet agent).
* Known diagnosis of systemic lupus erythematosus, scleroderma or other autoimmune connective tissue disorder.
* Subject is or has been enrolled in another investigational study within 6 months of participation into the EndoBarrier study.
* Subjects who are mentally retarded or emotionally unstable.
* Subjects who are pregnant or were breastfeeding.
* Subjects with an abnormal laboratory or ECG abnormality which the investigators deems clinically significant and makes the patient a poor candidate for the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Maximum Age:
20 Years
Study:
NCT02183935
Study Brief:
Protocol Section:
NCT02183935