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 @ 7:39 PM
Ignite Modification Date:
2025-12-24 @ 7:39 PM
NCT ID:
NCT00398203
Eligibility Criteria:
Inclusion Criteria:
* Male/Female aged between 18-80 years (inclusive).
* Subject is scheduled for endoscopic procedure after the case was reviewed by one of the investigators.
* Symptomatic subject defined as having at least one of the following signs or symptoms:
* Abdominal pain
* Cramps
* Bloating
* Diarrhea
* Nausea
* Vomiting
* Unexplained Anemia
* GI bleeding from an unknown source
* Small bowel abnormality on any imaging study
* Subject able to comprehend and give informed consent for participation in this study
* Signed Informed Consent Form
Exclusion Criteria:
* Pregnancy
* Acute bowel obstruction
* Concomitant Coumadin or warfarin use
* Severe diverticulitis
* Recent (within the last 3 months) coronary ischemia or CVA (stroke)
* Any chronic unstable disease
* Bleeding disorders
* Needing emergency surgery
* Any patient condition deemed too risky for SBE by the investigator
* Known cognitive or psychiatric disorder
* Physician objection
* Concurrent participation in any other clinical trial
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT00398203
Study Brief:
Protocol Section:
NCT00398203