The Clinical Utility of Overtube Use at the Time of Endoscopy
| Status: | Completed |
|---|---|
| Conditions: | Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 10/21/2012 |
| Start Date: | June 2007 |
| End Date: | February 2014 |
| Contact: | Peter Draganov, MD |
| Email: | peter.draganov@medicine.ufl.edu |
| Phone: | 352-392-2877 |
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.
Inclusion Criteria:
1. Subjects ≥ 18 years.
2. 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.
3. Scheduled to undergo enteroscopy at the University of Florida, Gainesville, Florida,
as medically indicated.
4. Subject must be able to give informed consent.
Exclusion Criteria:
1. Platelets < 75,000.
2. INR > 1.6.
3. NSAIDS within 48 hours of procedure.
4. Pregnancy.
5. Esophageal stricture.
6. Inability to give informed consent.
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