Use of Goggle Balloon to Improve Cecal Intubation During Colonoscopy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Indiana University
- 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
Colonoscopy will be performed using the water immersion technique.
Intervention: water immersion only (Other)
water immersion with goggle balloon
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
Douglas K. Rex
Director of Endoscopy
Indiana University
