Use of Goggle Balloon to Improve Cecal Intubation During Colonoscopy
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Colorectal Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | August 2015 |
| End Date: | January 2017 |
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in intubated, the goggle balloon is typically deflated and withdrawn back through the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.
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.
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.
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.
Inclusion Criteria:
- history of incomplete colonoscopy due to redundant colon
- 18 years of age or older
Exclusion Criteria:
- Known Stricture in colon
We found this trial at
1
site
550 University Boulevard
Indianapolis, Indiana 46202
Indianapolis, Indiana 46202
Principal Investigator: Douglas K Rex, MD
Phone: 317-948-2031
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