N/A
N=193
The Clinical Utility of Overtube Use at the Time of Endoscopy
Small Bowel Visualization
Bottom Line
View on ClinicalTrials.gov: NCT00861263 ↗Enrolled (actual)
193
Serious AEs
4.2%
Results posted
Apr 2014
Primary outcome: Primary: Number of Patients With Persistent or Recurrent Bleeding — 16 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- overtube use during enteroscopy (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Florida
- Primary completion
- Oct 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With Persistent or Recurrent Bleeding |
16 | — |
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.
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 1.6.
- NSAIDS within 48 hours of procedure.
- Pregnancy.
- Esophageal stricture.
- Inability to give informed consent.
Data sourced from ClinicalTrials.gov (NCT00861263). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.