Experimental Device to Improve Colonoscopy
| Status: | Completed |
|---|---|
| Conditions: | Colorectal Cancer, Cancer, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology, Oncology |
| Healthy: | No |
| Age Range: | 40 - 80 |
| Updated: | 4/22/2017 |
| Start Date: | July 11, 2008 |
| End Date: | September 21, 2016 |
A Trial of Segmental Stiffening Wires to Improve the Efficiency and Patient Tolerability of Colonoscopy
This study will test the use of a new device called a segmental stiffening wire (SSW) in
colonoscopy to correct a problem called looping. Colonoscopy is the best test for detecting
early colon cancer and removing growths called polyps, which can become colon cancer.
Sometimes the flexible tube (colonoscope) used in the procedure loops at a certain point as
it advances through the colon, making it difficult to move further and causing the patient
pain from excessive stretching of the colon. The SSW is designed to prevent this by
stiffening the part of the tube that would otherwise form the loop.
Healthy subjects between 50 and 80 years of age and healthy subjects 40 years and older who
have a family history of colon cancer may be eligible for this study.
Participants undergo colonoscopy a day after self-administering a bowel cleansing
preparation. The first part of the procedure is done similarly to that of a flexible
sigmoidoscopy, and no sedation or pain medication is used. The colonoscope is inserted into
the rectum and advanced about one-third the length of the colon. Pain or discomfort should
be mild to moderate cramping and a feeling of having to move the bowels. The subject is
asked to score his or her pain level at this point using a standard pain scale. If there is
pain, the procedure is stopped and an x-ray is taken to determine if the colonoscope has
looped. If it has, the loop is undone and the SSW is used. Another x-ray is then taken to
document that the loop has been prevented with the SSW, and the procedure is completed as
per standard medical practice. Subjects are taken to the recovery area, informed of the test
results and then discharged home in the care of an accompanying adult.
colonoscopy to correct a problem called looping. Colonoscopy is the best test for detecting
early colon cancer and removing growths called polyps, which can become colon cancer.
Sometimes the flexible tube (colonoscope) used in the procedure loops at a certain point as
it advances through the colon, making it difficult to move further and causing the patient
pain from excessive stretching of the colon. The SSW is designed to prevent this by
stiffening the part of the tube that would otherwise form the loop.
Healthy subjects between 50 and 80 years of age and healthy subjects 40 years and older who
have a family history of colon cancer may be eligible for this study.
Participants undergo colonoscopy a day after self-administering a bowel cleansing
preparation. The first part of the procedure is done similarly to that of a flexible
sigmoidoscopy, and no sedation or pain medication is used. The colonoscope is inserted into
the rectum and advanced about one-third the length of the colon. Pain or discomfort should
be mild to moderate cramping and a feeling of having to move the bowels. The subject is
asked to score his or her pain level at this point using a standard pain scale. If there is
pain, the procedure is stopped and an x-ray is taken to determine if the colonoscope has
looped. If it has, the loop is undone and the SSW is used. Another x-ray is then taken to
document that the loop has been prevented with the SSW, and the procedure is completed as
per standard medical practice. Subjects are taken to the recovery area, informed of the test
results and then discharged home in the care of an accompanying adult.
Colonoscopy can be challenging to perform and painful due to looping of the colonoscope.
Looping occurs when further insertion of the colonoscope results in a loop forming in the
shaft of the colonoscope instead of advancement of the tip. Attempts have been made to solve
this problem, but to date there is no perfect solution. Since colonoscopy is the gold
standard for colon cancer screening providing a device that could prevent looping would be
valuable. We have developed an experimental device that has not been approved outside of the
context of this study known as the Segmental Stiffening Wire (SSW). This wire will be
utilized by passing it through the biopsy channel of the endoscope. The wire has a 15-25
inch area of increased thickness and stiffness. The stiffened section can be advanced into
areas of looping in an effort to prevent re-looping. We will conduct a pilot study in two
phases. The first phase will include approximately 10 healthy volunteers who will undergo
colonoscopy using the SSW. Fluoroscopy will be used to determine if the device prevents
re-looping. If in phase 1 the device is successful in over 30% of episodes, the second phase
will be undertaken. In the second phase volunteers willing to undergo two colonoscopies on
consecutive days will be recruited. Volunteers who experience looping will be randomized as
to whether the SSW is available. These volunteers will then undergo an otherwise identical
colonoscopy on the following day except the SSW will be available if it was not on the first
colonoscopy or it will not be available if it was on the first colonoscopy. Volunteers who
undergo two colonoscopies will not need a second bowel preparation but will be maintained on
a clear liquid diet between the two procedures. Volunteers in which looping does not occur
will have their initial colonoscopy completed as normal and then will leave the study. If
unable to obtain sufficient volunteers willing to undergo dual colonoscopy, then volunteers
willing to undergo single colonoscopy will be included and their procedures will be done
with or without the SSW in random fashion. The endpoints will be cecal intubation time;
cecal intubation rate; quantity of sedation/analgesia; number of ancillary maneuvers;
pain/sedation as measured by the Visual Analog Pain Scale, the Ramsey Sedation Scale, and
clinical observations; vital sign changes; and the endoscopists subjective assessment of
procedure difficulty and the usefulness of the SSW.
Looping occurs when further insertion of the colonoscope results in a loop forming in the
shaft of the colonoscope instead of advancement of the tip. Attempts have been made to solve
this problem, but to date there is no perfect solution. Since colonoscopy is the gold
standard for colon cancer screening providing a device that could prevent looping would be
valuable. We have developed an experimental device that has not been approved outside of the
context of this study known as the Segmental Stiffening Wire (SSW). This wire will be
utilized by passing it through the biopsy channel of the endoscope. The wire has a 15-25
inch area of increased thickness and stiffness. The stiffened section can be advanced into
areas of looping in an effort to prevent re-looping. We will conduct a pilot study in two
phases. The first phase will include approximately 10 healthy volunteers who will undergo
colonoscopy using the SSW. Fluoroscopy will be used to determine if the device prevents
re-looping. If in phase 1 the device is successful in over 30% of episodes, the second phase
will be undertaken. In the second phase volunteers willing to undergo two colonoscopies on
consecutive days will be recruited. Volunteers who experience looping will be randomized as
to whether the SSW is available. These volunteers will then undergo an otherwise identical
colonoscopy on the following day except the SSW will be available if it was not on the first
colonoscopy or it will not be available if it was on the first colonoscopy. Volunteers who
undergo two colonoscopies will not need a second bowel preparation but will be maintained on
a clear liquid diet between the two procedures. Volunteers in which looping does not occur
will have their initial colonoscopy completed as normal and then will leave the study. If
unable to obtain sufficient volunteers willing to undergo dual colonoscopy, then volunteers
willing to undergo single colonoscopy will be included and their procedures will be done
with or without the SSW in random fashion. The endpoints will be cecal intubation time;
cecal intubation rate; quantity of sedation/analgesia; number of ancillary maneuvers;
pain/sedation as measured by the Visual Analog Pain Scale, the Ramsey Sedation Scale, and
clinical observations; vital sign changes; and the endoscopists subjective assessment of
procedure difficulty and the usefulness of the SSW.
- INCLUSION CRITERIA:
Colonoscopy is indicated based on well-established national guidelines. This includes
volunteers age 50 or greater who are at average risk for colon cancer, and volunteers age
40 or greater who are at increased risk based on a personal history of colon polyps or a
family history of colon polyps or cancer.
Volunteer meets the criteria of Anesthesia Level 1 or 2.
Volunteer agrees to undergo the study procedures.
EXCLUSION CRITERIA:
Ongoing psychiatric history including volunteers who have been hospitalized for
psychiatric reasons, have missed significant number of days of work for psychiatric
reasons, or who admit to suicidal ideations.
Former or current history of alcohol or drug dependency.
History of colonic resection.
Pregnancy.
Age greater than 80 or less than 40.
Prior radiation to the abdomen or pelvis.
American Society of Anesthesiologists Grade 3, 4, or 5.
Allergy or other contraindications to midazolam or fentanyl.
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
Phone: 800-411-1222
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