The Clinical Utility of Overtube Use at the Time of Endoscopy (Spirus)

University of Florida

Status: Completed

Conditions: Small Bowel Visualization

Treatments: Device: overtube use during enteroscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT00861263

Spirus Overtube

Details and patient eligibility

About

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.

Enrollment: 193 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

193 participants in 1 patient group

spiral overtube

Other group

Description:

Any subject that has been referred for spiral enteroscopy will be asked to participate in this study. The purpose is to gather data about the technical aspects of the procedure,diagnostic capability and treatment as well as long term follow up.

Treatment:

Device: overtube use during enteroscopy