The Clinical Utility of Overtube Use at the Time of Endoscopy
Completed · Not applicable
Conditions studied: Small Bowel Visualization
In brief
Endoscopy has become a vital part of the gastroenterologist's evaluation and treatment of disorders involving the gastrointestinal (GI) tract. The small bowel is an area of the GI tract, which can prove difficult to visualize during an endoscopy specifically designed to evaluate it, termed enteroscopy. Thus, the FDA has approved overtubes, such as the Endo-Ease® spiral overtube (Spirus Medical, Inc.) or EnteroPro® balloon overtube (Olympus Medical, Inc.), to facilitate passage of the endoscope through the GI tract. The aims of the study are to evaluate the efficiency of an overtube system for visualization of small bowel. The hypothesis is that this will permit more complete and efficient evaluation of the small intestine.
Key facts
- Study ID
- NCT00861263
- Run by
- University of Florida
- People needed
- 193
- Starts
- 2007-06-01
- Expected to finish
- 2012-10-01
- Last updated by the study team
- 2014-04-14
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Subjects ≥ 18 years.
- Have an indication for enteroscopy as determined by the patient's physicians. These indications include, but are not limited to, obscure gastrointestinal bleeding, malabsorption, suspected small bowel tumor, small bowel strictures, small bowel ulceration, and abnormal imaging of the small bowel.
- Scheduled to undergo enteroscopy at the University of Florida, Gainesville, Florida, as medically indicated.
- Subject must be able to give informed consent.
You may not qualify if…
- Platelets < 75,000.
- INR > 1.6.
- NSAIDS within 48 hours of procedure.
- Pregnancy.
- Esophageal stricture.
- Inability to give informed consent.
Where it is running
- Shands at UF — Gainesville, Florida, United States
Full record on ClinicalTrials.gov
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