Use of Goggle Balloon to Improve Cecal Intubation During Colonoscopy

Redundant Colon Clinical Trial

Official title:

Use of Goggle Balloon to Improve Cecal Intubation During Colonoscopy

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02359409
• Other study ID #: IndianaU
• Status: Withdrawn
• Phase: N/A
• First received: January 30, 2015
• Last updated: April 27, 2017
• Start date: July 2014
• Est. completion date: March 28, 2017

Study information

• Verified date: April 2017
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Other known NCT identifiers

• NCT02539888

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 28, 2017
• Est. primary completion date: March 28, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Referral for incomplete colonoscopy

Exclusion Criteria:

Known stricture or narrowing of the colon, prior colon resection

Related Conditions & MeSH terms

• Redundant Colon

Intervention

Device:
• goggle balloon
Colonoscopy will be performed using the water immersion technique.

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

Locations

Country	Name	City	State
United States	Indiana University Hospital	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of subjects with complete colonoscopy in each arm		2 years
Secondary	Time to cecal intubation in each arm		2 years