The Clinical Utility of Overtube Use at the Time of Endoscopy

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

193 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2012-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Small Bowel Visualization

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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spiral overtube

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.

Group Type OTHER

overtube use during enteroscopy

Intervention Type DEVICE

use of overtube for the regular scheduled enteroscopy

Interventions

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overtube use during enteroscopy

use of overtube for the regular scheduled enteroscopy

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes