Overview

This trial is active, not recruiting.

Condition redundant colon
Treatments goggle balloon, water immersion only
Sponsor Indiana University
Start date July 2014
End date July 2017
Trial size 60 participants
Trial identifier NCT02359409, IndianaU, NCT02539888

Summary

This study aims to look if use of goggle balloon can help to complete colonoscopy in patients with very redundant colons.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Active Comparator)
Colonoscopy will be performed using the water immersion technique.
water immersion only
Colonoscopy will be performed using a goggle balloon at the tip of the scope with water immersion technique.
(Experimental)
Colonoscopy will be performed using a goggle balloon at the tip of the scope with water immersion technique
goggle balloon
Colonoscopy will be performed using the water immersion technique.

Primary Outcomes

Measure
number of subjects with complete colonoscopy in each arm
time frame: 2 years

Secondary Outcomes

Measure
Time to cecal intubation in each arm
time frame: 2 years

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: Referral for incomplete colonoscopy Exclusion Criteria: Known stricture or narrowing of the colon, prior colon resection

Additional Information

Official title Use of Goggle Balloon to Improve Cecal Intubation During Colonoscopy
Principal investigator Douglas K Rex, MD
Description About 5% of colonoscopies are technically difficult because the colon is elongated or redundant. There is an increased risk of the colonoscope not reaching the cecum in these cases. One solution to this is to try to keep the colon shorter by not insufflating it with gas. In order to achieve that, in these cases the investigators typically fill the colon with water, which does not distend the colon as much. Another technique, which can improve visualization, is to use a device called the goggle balloon. This is a small balloon filled with a few mL of water which fits over the end of the colonoscope and pushes the colonic mucosa away from the end of the scope so that the luminal direction can be visualized with minimal insufflation. In patients with normal colons, the goggle balloon can be used to insert the colonoscope to the cecum with virtually no air or water filling. We aim to study if the goggle balloon can be used to help complete the colonoscopy in patients with redundant colons.
Trial information was received from ClinicalTrials.gov and was last updated in December 2016.
Information provided to ClinicalTrials.gov by Indiana University.