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
  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:


Further study details as provided by University of Florida:

Primary Outcome Measures:
  • 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.


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
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.
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Results First Received: November 12, 2013
Last Updated: March 7, 2014
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on August 19, 2014