The Clinical Utility of Overtube Use at the Time of Endoscopy (Spirus)
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.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||The Clinical Utility of Overtube Use at the Time of Endoscopy|
- 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.
|Study Start Date:||June 2007|
|Study Completion Date:||October 2012|
|Primary Completion Date:||October 2012 (Final data collection date for primary outcome measure)|
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00861263
|United States, Florida|
|Shands at UF|
|Gainesville, Florida, United States, 32610|
|Principal Investigator:||Peter Draganov, MD||University of Florida, Division of Gastroenterology|