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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00861263
Recruitment Status : Completed
First Posted : March 13, 2009
Results First Posted : April 14, 2014
Last Update Posted : April 14, 2014
Information provided by (Responsible Party):
University of Florida

March 12, 2009
March 13, 2009
November 12, 2013
April 14, 2014
April 14, 2014
June 2007
October 2012   (Final data collection date for primary outcome measure)
Number of Patients With Persistent or Recurrent Bleeding [ Time Frame: up to 6 yrs after after the endoscopy ]
The number of patients that had persistent or recurrent GI bleeding after spiral enteroscopy.
To determine the depth of insertion of the enteroscope, the time taken for enteroscopy and the efficacy, usefulness and impact on patients of the procedure [ Time Frame: at end of procedure or retrospective chart review ]
Complete list of historical versions of study NCT00861263 on Archive Site
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The Clinical Utility of Overtube Use at the Time of Endoscopy
The Clinical Utility of Overtube Use at the Time of Endoscopy
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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Intervention Model: Single Group Assignment
Masking: None (Open Label)
Small Bowel Visualization
Device: overtube use during enteroscopy
use of overtube for the regular scheduled enteroscopy
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.
Intervention: Device: overtube use during enteroscopy

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
October 2012
October 2012   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
Spirus Overtube
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University of Florida
University of Florida
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Principal Investigator: Peter Draganov, MD University of Florida, Division of Gastroenterology
University of Florida
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP