The Clinical Utility of Overtube Use at the Time of Endoscopy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Small Bowel Visualization
- Sponsor
- University of Florida
- Enrollment
- 193
- Locations
- 1
- Primary Endpoint
- Number of Patients With Persistent or Recurrent Bleeding
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •Platelets \< 75,
- •NSAIDS within 48 hours of procedure.
- •Esophageal stricture.
- •Inability to give informed consent.
Outcomes
Primary Outcomes
Number of Patients With Persistent or Recurrent Bleeding
Time Frame: up to 6 yrs after after the endoscopy
The number of patients that had persistent or recurrent GI bleeding after spiral enteroscopy.