The Clinical Utility of Overtube Use at the Time of Endoscopy

University of Florida193 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Masking

NONE

Enrollment

193

Conditions

Small Bowel Visualization

Interventions

overtube use during enteroscopy

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Number of Patients With Persistent or Recurrent Bleeding

The number of patients that had persistent or recurrent GI bleeding after spiral enteroscopy.

Time frame: up to 6 yrs after after the endoscopy