Trial of Wireless Capsule Endoscopy in the Evaluation of Obscure Gastrointestinal Bleeding
Status and phase
Conditions
Treatments
Details and patient eligibility
About
This study compares wireless capsule endoscopy (patients swallow a pill-size camera that sends pictures of the intestine to a recorder worn on their belt) to an x-ray study (called dedicated small bowel contrast radiography) in patients who have bleeding from the gastrointestinal tract without a source of the bleeding identified on routine endoscopic examinations of the esophagus (food pipe), stomach, small intestine, and large intestine.
The investigators hope to determine if the capsule is a better test in terms of decreasing further bleeding, decreasing the need for further diagnostic testing, and decreasing the need for blood transfusions and time spent in the hospital.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Iron deficiency anemia in men or post-menopausal women and positive fecal occult blood test in pre-menopausal women with nondiagnostic upper endoscopy, colonoscopy, and push enteroscopy.
- Persistent or recurrent melena or hematochezia with nondiagnostic upper endoscopy, colonoscopy, and push enteroscopy.
Exclusion criteria
- Known or suspected GI tract obstruction
- Severe motility disorders (e.g., achalasia, gastroparesis, pseudoobstruction)
- Pregnancy
- Cardiac pacemaker or implanted electro-medical devices
Trial design
Primary purpose
Allocation
Interventional model
Masking
136 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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