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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: March 7, 2014
Last verified: March 2014

March 12, 2009
March 7, 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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00861263 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
193
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.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00861263
Spirus Overtube
No
University of Florida
University of Florida
Not Provided
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