Use of Goggle Balloon to Improve Cecal Intubation During Colonoscopy

Colon Cancer Clinical Trial

Official title:

Use of Goggle Balloon to Improve Cecal Intubation During Colonoscopy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02539888
• Other study ID #: 1404878264
• Status: Not yet recruiting
• Phase: N/A
• First received: April 29, 2014
• Last updated: August 29, 2016
• Start date: August 2017
• Est. completion date: January 2020

Study information

• Verified date: August 2016
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This is a randomized trial testing whether a device called the "goggle balloon" can improve cecal intubation in patients with known redundant colons. Because of Dr. Rex's expertise in colonoscopy, he is often referred patients who have had an attempt at colonoscopy by another physician and the physician was unable to reach the beginning of the colon because the colon was elongated or redundant. Dr. Rex has published several reports of his experience in performing colonoscopy in these patients, with a success rate of 96%. The current tools that are used for most such cases are a standard adult size colonoscope and water immersion. Water immersion refers to filling the colon with water rather than air, since water tends to distend the colon and elongate it less than air or other gas.

The goggle balloon is a simple device that is passed down through the instrument channel on a catheter. Once it exits the tip of the colonoscope, it is filled with a few ml of water and pulled back on to the colonoscope tip. A cap is placed over the end of colonoscope (Olympus distal attachment) and sticks out approximately 4 mm from the end of the colonoscope. The balloon is centered by this cap. The doctor then looks at the video screen through the water-filled balloon.

This device has been shown helpful in keeping the mucosa off the ends of the folds and allows the doctor to identify the luminal direction without distending the colon. It is possible that the goggle balloon would be in addition to the colonoscopy in patients with redundant colons that would further shorten the time taken to intubate the cecum and complete the colonoscopy.

Both the goggle balloon and the Olympus distal attachment cap are FDA 510k cleared devices. Dr. Rex has used the distal cap on hundreds of previous colonoscopies, and performed several trials with it. Dr. Rex has also used the goggle balloon for a number of colonoscopies, and has found it easy to use and does not pose any perceivable risk to patients. Once the cecum in intubated, the goggle balloon is typically deflated and withdrawn back through the colonoscope.

Description:

Patients will be randomized in a 1 to 1 ratio to undergo colonoscopy with water immersion alone versus colonoscopy with water immersion plus the goggle device. During the colonoscopy, the investigators will time the cecal intubation and record all ancillary maneuvers (abdominal pressure, position change, etc. ) which are necessary to achieve cecal intubation. Once cecal intubation is achieved, or the colonoscopist decides that cecal intubation is not feasible during the procedure, the subject's participation is complete.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: January 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• history of incomplete colonoscopy due to redundant colon

• 18 years of age or older

Exclusion Criteria:

• Known Stricture in colon

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• Colon Cancer
• Redundant Colon

Intervention

Device:
• Goggle Balloon
To determine if goggle balloon can help in patients who have very redundant colons. It is a randomized trial, and one arm will undergo colonoscopy with a standard instrument using water immersion, and the other arm will have water immersion plus the goggle balloon.

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	Effectiveness of Goggle Balloon in assisting in cecal intubation in patients with redundant colons. The Outcome Measure will be assessed and reviewed by a Statistician.	During the colonoscopy, the investigators will time the cecal intubation and record all ancillary maneuvers (abdominal pressure, position change, etc. ) which are necessary to achieve cecal intubation. The goal of this study is being done to determine if the goggle balloon can help in patients who have very redundant colons. It is a randomized trial, and one arm will be assessed that undergo colonoscopy with a standard instrument using water immersion, and the other arm that will be assessed will have water immersion plus the goggle balloon. 60 participants	1 day participants will be followed for the duration colonoscopy stay	No