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

Status Not yet recruiting

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 Once the cecum in intubated, the goggle balloon is typically deflated and withdrawn back through the colonoscope.

Clinical Trial 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. ;

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

• NCT number: NCT02539888
• Study type: Interventional
• Source: Indiana University
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 2017
• Completion date: January 2020