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OpenTrials
Completed

NCT Number: NCT00861263

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.

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Key information

Conditions

Small Bowel Visualization

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shands at UF

Gainesville, Florida, 32610, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects ≥ 18 years.
  • 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.
  • Scheduled to undergo enteroscopy at the University of Florida, Gainesville, Florida, as medically indicated.
  • Subject must be able to give informed consent.

Exclusion criteria

  • Platelets < 75,000.
  • INR > 1.6.
  • NSAIDS within 48 hours of procedure.
  • Pregnancy.
  • Esophageal stricture.
  • Inability to give informed consent.

Treatment and study plan

overtube use during enteroscopy

Device

use of overtube for the regular scheduled enteroscopy

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Acronym: Spirus

Important dates

Study start
2007
Primary completion
2012
Study completion
2012
First posted
Mar 13, 2009
Registry last updated
Apr 14, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.