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Clinical Trials/NCT02359409
NCT02359409WithdrawnNot Applicable

Use of Goggle Balloon to Improve Cecal Intubation During Colonoscopy

Indiana University1 site in 1 countryStarted: July 1, 2014Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Withdrawn
Locations
1
Primary Endpoint
number of subjects with complete colonoscopy in each arm

Study Overview

Brief Summary

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

Detailed 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Referral for incomplete colonoscopy

Exclusion Criteria

  • •Known stricture or narrowing of the colon, prior colon resection

Arms & Interventions

water immersion only

Active Comparator

Colonoscopy will be performed using the water immersion technique.

Intervention: water immersion only (Other)

water immersion with goggle balloon

Experimental

Colonoscopy will be performed using a goggle balloon at the tip of the scope with water immersion technique

Intervention: goggle balloon (Device)

Outcomes

Primary Outcomes

number of subjects with complete colonoscopy in each arm

Time Frame: 2 years

Secondary Outcomes

  • Time to cecal intubation in each arm(2 years)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Douglas K. Rex

Director of Endoscopy

Indiana University

Study Sites (1)

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