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Use of Goggle Balloon to Improve Cecal Intubation During Colonoscopy

Use of Goggle Balloon to Improve Cecal Intubation During Colonoscopy

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02359409
Enrollment
0
Registered
2015-02-10
Start date
2014-07-31
Completion date
2017-03-28
Last updated
2017-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Redundant Colon

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.

Interventions

DEVICEgoggle balloon

Colonoscopy will be performed using the water immersion technique.

OTHERwater immersion only

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

Sponsors

Indiana University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

Referral for incomplete colonoscopy

Exclusion criteria

Known stricture or narrowing of the colon, prior colon resection

Design outcomes

Primary

MeasureTime frame
number of subjects with complete colonoscopy in each arm2 years

Secondary

MeasureTime frame
Time to cecal intubation in each arm2 years

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026