Use of Goggle Balloon to Improve Cecal Intubation During Colonoscopy

NCT ID: NCT02359409

Last Updated: 2017-04-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2017-03-28

Brief Summary

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

Detailed Description

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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.

Conditions

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Redundant Colon

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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water immersion only

Colonoscopy will be performed using the water immersion technique.

Group Type ACTIVE_COMPARATOR

water immersion only

Intervention Type OTHER

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

water immersion with goggle balloon

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

Group Type EXPERIMENTAL

goggle balloon

Intervention Type DEVICE

Colonoscopy will be performed using the water immersion technique.

Interventions

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goggle balloon

Colonoscopy will be performed using the water immersion technique.

Intervention Type DEVICE

water immersion only

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

Referral for incomplete colonoscopy

Exclusion Criteria

Known stricture or narrowing of the colon, prior colon resection
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Indiana University

OTHER

Sponsor Role lead

Responsible Party

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Douglas K. Rex

Director of Endoscopy

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Douglas K Rex, MD

Role: PRINCIPAL_INVESTIGATOR

IU Medical Center

Locations

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Indiana University Hospital

Indianapolis, Indiana, United States

Site Status

Countries

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United States

Other Identifiers

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IndianaU

Identifier Type: -

Identifier Source: org_study_id

NCT02539888

Identifier Type: -

Identifier Source: nct_alias

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