We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
ClinicalTrials.gov Identifier: NCT00861263
Recruitment Status : Completed
First Posted : March 13, 2009
Results First Posted : April 14, 2014
Last Update Posted : April 14, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
Small Bowel Visualization Device: overtube use during enteroscopy

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 193 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: The Clinical Utility of Overtube Use at the Time of Endoscopy
Study Start Date : June 2007
Primary Completion Date : October 2012
Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. 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.


Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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