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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT00861263
First received: March 12, 2009
Last updated: October 25, 2012
Last verified: September 2012
History of Changes
  Purpose

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.


Condition Intervention
Small Bowel Visualization
 Device: overtube use during enteroscopy

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: The Clinical Utility of Overtube Use at the Time of Endoscopy

Resource links provided by NLM:

MedlinePlus related topics: Endoscopy
U.S. FDA Resources

Further study details as provided by University of Florida:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 193
Study Start Date: June 2007
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
enteroscopy
Any subject that has been referred for enteroscopy will be asked to participate in this study
 Device: overtube use during enteroscopy
use of overtube for the regular scheduled enteroscopy

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00861263

Locations
United States, Florida
Shands at UF
Gainesville, Florida, United States, 32610
Sponsors and Collaborators
University of Florida
Investigators
Principal Investigator: Peter Draganov, MD University of Florida, Division of Gastroenterology
  More Information

No publications provided by University of Florida

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT00861263     History of Changes
Other Study ID Numbers: Spirus Overtube
Study First Received: March 12, 2009
Last Updated: October 25, 2012
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on May 16, 2013