ColonoscopyNCT00719641
Experimental Device to Improve Colonoscopy
An observational study of Colonoscopy and Looping, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Colonoscopy, Looping, Prevent Looping
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Aug 2008to 21 Sep 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Colonoscopy, Looping, Prevent Looping, Colon Cancer Screening
- Keywords
- Colonoscopy, Looping, Prevent Looping, Colon Cancer Screening, Segmental Stiffening Wire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Phase 1: Single Colonoscopy | Feasibility testing using the segmental stiffening wire | |
| Phase 2; Not randomized | Phase 2 participants who did not have looping during first colonoscopy | |
| Phase 2: Randomized to SSW during first colonoscopy | Phase 2 participants in whom looping occurred on first biopsy, randomized to subsequent use of segmental stiffening wire, then colonoscopy with no segmental stiffening wire upon repeat colonoscopy the next day. | |
| Phase 2: Randomized to SSW during second colonoscopy | Phase 2 participants in whom looping occurred on first biopsy, randomized to no subsequent use of the segmental stiffening wire that day, then colonoscopy with segmental stiffening wire upon repeat colonoscopy the next day. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cecal Intubation Time
Cecal intubation time of colonoscopy with SSW, compared to without SSW
Measured: During colonoscopy, up to 60 minutes
Number of Participants Without Re-looping Among Those With Looping
Re-looping during the procedure that used SSW, this information only collected when using SSW
Measured: During the colonoscopy, up to 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2008 (estimated)
- Study start5 Aug 2008
- Primary completion21 Sep 2016
- Study completion21 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ColonoscopyStudies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Stephen A Wank, M.D., Principal investigator, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00719641
- Sponsor's protocol ID
- 080173
- Other IDs
- 08-DK-0173
- Status last verified
- Oct 2019
- First submitted
- 19 Jul 2008
- Last updated
- 24 Mar 2020
- Results posted
- No
Publications
Meissner HI, Breen N, Klabunde CN, Vernon SW. Patterns of colorectal cancer screening uptake among men and women in the United States. Cancer Epidemiol Biomarkers Prev. 2006 Feb;15(2):389-94. doi: 10.1158/1055-9965.EPI-05-0678.
PubMed 16492934Kahi CJ, Rex DK. Current and future trends in colorectal cancer screening. Cancer Metastasis Rev. 2004 Jan-Jun;23(1-2):137-44. doi: 10.1023/a:1025871231346.
PubMed 15000154Wu GH, Wang YM, Yen AM, Wong JM, Lai HC, Warwick J, Chen TH. Cost-effectiveness analysis of colorectal cancer screening with stool DNA testing in intermediate-incidence countries. BMC Cancer. 2006 May 24;6:136. doi: 10.1186/1471-2407-6-136.
PubMed 16723013
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Trial of Segmental Stiffening Wires to Improve the Efficiency and Patient Tolerability of Colonoscopy
- ClinicalTrials.gov ID
- NCT00719641
- Acronym / sponsor ID
- 080173
- Conditions
- Colonoscopy, Looping, Prevent Looping, Colon Cancer Screening
- Keywords
- Colonoscopy, Looping, Prevent Looping, Colon Cancer Screening, Segmental Stiffening Wire
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Study start
- 5 Aug 2008 (actual)
- Primary completion
- 21 Sep 2016 (actual)
- Study completion
- 21 Sep 2016 (actual)
- First posted
- 22 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Phase 1: Single Colonoscopy | – | –Feasibility testing using the segmental stiffening wire |
| Phase 2; Not randomized | – | –Phase 2 participants who did not have looping during first colonoscopy |
| Phase 2: Randomized to SSW during first colonoscopy | – | –Phase 2 participants in whom looping occurred on first biopsy, randomized to subsequent use of segmental stiffening wire, then colonoscopy with no segmental stiffening wire upon repeat colonoscopy the next day. |
| Phase 2: Randomized to SSW during second colonoscopy | – | –Phase 2 participants in whom looping occurred on first biopsy, randomized to no subsequent use of the segmental stiffening wire that day, then colonoscopy with segmental stiffening wire upon repeat colonoscopy the next day. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cecal Intubation Time
Time frame: During colonoscopy, up to 60 minutes
Cecal intubation time of colonoscopy with SSW, compared to without SSW
Number of Participants Without Re-looping Among Those With Looping
Time frame: During the colonoscopy, up to 60 minutes
Re-looping during the procedure that used SSW, this information only collected when using SSW
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2020.
- Background: PubMed 16492934Meissner HI, Breen N, Klabunde CN, Vernon SW. Patterns of colorectal cancer screening uptake among men and women in the United States. Cancer Epidemiol Biomarkers Prev. 2006 Feb;15(2):389-94. doi: 10.1158/1055-9965.EPI-05-0678.
- Background: PubMed 15000154Kahi CJ, Rex DK. Current and future trends in colorectal cancer screening. Cancer Metastasis Rev. 2004 Jan-Jun;23(1-2):137-44. doi: 10.1023/a:1025871231346.
- Background: PubMed 16723013Wu GH, Wang YM, Yen AM, Wong JM, Lai HC, Warwick J, Chen TH. Cost-effectiveness analysis of colorectal cancer screening with stool DNA testing in intermediate-incidence countries. BMC Cancer. 2006 May 24;6:136. doi: 10.1186/1471-2407-6-136.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen A Wank, M.D. principal investigator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colonoscopy and Looping, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cecal Intubation Time (time frame: During colonoscopy, up to 60 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00719641, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2020.