The Clinical Utility of Overtube Use at the Time of Endoscopy

Not Applicable

Completed

• Conditions: Small Bowel Visualization
• Interventions: Device: overtube use during enteroscopy

• Registration Number: NCT00861263
• Lead Sponsor: University of Florida

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-06
• Study First Submitted: 2009-03-12
• Study First Submitted QC: 2009-03-12
• Study First Posted: 2009-03-13
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Results First Submitted: 2013-11-12
• Status Verified: 2014-03
• Results First Submitted QC: 2014-03-07
• Last Update Submitted: 2014-03-07
• Results First Posted: 2014-04-14
• Last Update Posted: 2014-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 193

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
spiral overtube	overtube use during enteroscopy	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.

Primary Outcome Measures

Name	Time	Method
Number of Patients With Persistent or Recurrent Bleeding	up to 6 yrs after after the endoscopy	The number of patients that had persistent or recurrent GI bleeding after spiral enteroscopy.

Trial Locations

Locations (1)

Shands at UF; 🇺🇸 Gainesville, Florida, United States