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Prospective Randomized Trial of Anterograde Single Balloon Versus Spirus Enteroscopy

NCT01853241 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2013-05-14

No results posted yet for this study

Summary

The small bowel is poorly suited to standard endoscopy techniques due to its anatomical differences from the colon and the upper gastrointestinal tract. The small bowel has an average length of 6.7 m, with a free mesentery that resists standard "push to advance" endoscopy techniques. New developments in overtubes, which are placed over an enteroscope, have revolutionized doctors ability to deeply intubate the small bowel. Three types of 'augmented' enteroscopy, double balloon enteroscopy (DBE), single balloon enteroscopy (SBE) and spiral enteroscopy (SE), have been developed. Although studies have been performed on these individual techniques, there are no studies comparing SBE and SE, the two techniques used in Johns Hopkins.

The investigators propose performing a prospective, randomised trial, to assess the differences between these two techniques. The question of what differences there are between these two techniques, in terms of depth of insertion, diagnostic and therapeutic yields, time required for the procedure and the sedation requirements, are important questions to answer, and depending on the results, would affect the investigators approach to patients with small bowel disease.

Conditions

Interventions

PROCEDURE

Single Balloon

All patients in this group will undergo single balloon enteroscopy

PROCEDURE

Spirus

All patients in this group will undergo Spirus Enteroscopy

Sponsors & Collaborators

Principal Investigators

  • Patrick Okolo, MD · Johns Hopkins University

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2011-01-31
Completion
2011-01-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01853241 on ClinicalTrials.gov