AdenomaNCT01211132
Cap Assisted Colonoscopy for the Detection of Colon Polyps
A study testing Cap - Transparent retractable extension device. and Standard in people with Adenoma and Colon Polyps, run by American Society for Gastrointestinal Endoscopy at 1 site in United States.
Trial summary
This simple technique of attaching a transparent cap to the tip of the colonoscope has been evaluated in Japan for improving the detection of polyps and cecal intubation but has not been formally evaluated in the US and other western countries. Read more about this study
- Who is it for?
- Ages 21 to 85 years
- Conditions the study is for
- Adenoma, Colon Polyps, Colon Cancer
- What is being tested?
- Cap - Transparent retractable extension device. and Standard
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 462 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Nov 2010
- Phase
- Interventional
- 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 21 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Referral for screening and/or surveillance colonoscopy and the ability to provide informed consent.
Who cannot join
- prior surgical resection of any portion of colon,
- prior history of colon cancer,
- history of inflammatory bowel disease,
- use of anti-platelet agents or anticoagulants that precludes removal of polyps during the procedure,
- poor general condition or any other reason to avoid prolonged procedure time
- inability to give informed consent,
- inadequate bowel preparation.
- history of polyposis syndrome or HNPCC,
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Veterans Affairs Medical Center
Kansas City, Missouri, 64128
Deepthi S Rao, MBBS, 816-861-4700 ext. 56428, Deepthi.Rao@va.gov
About this study
Official title: Prospective Randomized Controlled Study of Cap Assisted Colonoscopy for the Detection of Colon Polyps
This simple technique of attaching a transparent cap to the tip of the colonoscope has been evaluated in Japan for improving the detection of polyps and cecal intubation but has not been formally evaluated in the US and other western countries. In one study (19), the polyp detection rate was higher with the transparent cap compared to no cap (49% vs. 39%, p=0.04). Also, the cecal intubation time was shorter with the cap (11.5 min vs 14 min, p=0.008). In a recently published study, a variation of the cap called the transparent retractable extension device was used (21). Overall, the number of adenomas detected were significantly higher with the device compared to without it (205 vs. 150, p=0.04). In an earlier study by Tada et al (22), use of a transparent cap improved the detection rate of lesions per patient (0.86 vs. 0.58) but did not increase the cecal intubation time. Finally, Lee et al (20) used cap assisted colonoscopy in patients with difficult colonoscopy procedure (defined as failure to pass through sigmoid colon after 20 minutes or failure to reach cecum). Using the cap, cecal intubation was achieved in 94% of patients and this proved to be an effective rescue method for failed or difficult colonoscopy. The major appeal of this technique is that it is inexpensive, very practical, and easy to use. Furthermore it is safe and there are no reported complications from this. If found to be effective in increasing the polyp yield it has the potential to being incorporated by busy gastroenterologists in their day to day clinical practice. These features and the preliminary data from Japan merit the evaluation of this promising technique in the US.
Read the detailed description
The investigators hypothesize that adenoma detection rate will be higher using cap assisted colonoscopy compared to standard colonoscopy. Also, cap assisted colonoscopy will be safe and cecal intubation rate will be similar compared to standard colonoscopy.
Specific Aim 1 - To compare the prevalence of adenomas detected by standard colonoscopy and cap assisted colonoscopy.
Specific Aim 2 - To compare the number of adenomas detected per subject by standard colonoscopy and cap assisted colonoscopy.
Specific aim 3 - To compare the cecal intubation rate, insertion time, withdrawal time and complications of standard colonoscopy and cap assisted colonoscopy.
- Conditions
- Adenoma, Colon Polyps, Colon Cancer
- Being tested
- Cap - Transparent retractable extension device., Standard
- Keywords
- Colon polyps, Adenoma detection, Cap, Standard, Colon Cancer
- Medical subject headings
- Adenoma, Colonic Polyps, Colonic Neoplasms, Anterior polar cataract 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cap - Transparent retractable extension device.Device
Also called Cap Assisted Colonoscopy
Attaching a Cap - Transparent retractable extension device.
StandardDevice
Also called Standard Colonoscopy
Without attaching a transparent cap to the tip of colonoscope.
| Study group | Role | What they receive |
|---|---|---|
| Cap arm | Active comparator | Not described Receives: Device: Cap - Transparent retractable extension device. |
| Standard arm | Active comparator | Not described Receives: Device: Standard |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome is the prevalence of adenomas in the two groups.
Measured: 2 years
Secondary outcomes (1)
The secondary outcomes are the number of adenomas detected per subject, cecal intubation rate, insertion times, withdrawal times and complication rates in the two arms.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2010 (estimated)
- Study startSep 2009
- Primary completionOct 2010 (estimated)
- Study completionNov 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AdenomaStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 462 participants (estimated)
Sponsor and investigators
- Lead sponsor
- American Society for Gastrointestinal Endoscopy
- Sponsor type
- University, hospital or other
- Collaborators
- Midwest Biomedical Research
- Investigators
- Amit Rastogi, MD, Principal investigator, Veterans Affairs Medical Center, Kansas City, MO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01211132
- Sponsor's protocol ID
- AR0006
- Status last verified
- Sep 2010
- First submitted
- 28 Sep 2010
- Last updated
- 29 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Rastogi A, Bansal A, Rao DS, Gupta N, Wani SB, Shipe T, Gaddam S, Singh V, Sharma P. Higher adenoma detection rates with cap-assisted colonoscopy: a randomised controlled trial. Gut. 2012 Mar;61(3):402-8. doi: 10.1136/gutjnl-2011-300187. Epub 2011 Oct 13.
PubMed 21997547
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Controlled Study of Cap Assisted Colonoscopy for the Detection of Colon Polyps
- ClinicalTrials.gov ID
- NCT01211132
- Acronym / sponsor ID
- AR0006
- Conditions
- Adenoma, Colon Polyps, Colon Cancer
- Keywords
- Colon polyps, Adenoma detection, Cap, Standard, Colon Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 462 participants (estimated)
- Lead sponsor
- American Society for Gastrointestinal EndoscopyUniversity, hospital or other
- Collaborators
- Midwest Biomedical Research
- Study start
- Sep 2009
- Primary completion
- Oct 2010 (estimated)
- Study completion
- Nov 2010 (estimated)
- First posted
- 29 Sep 2010 (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 simple technique of attaching a transparent cap to the tip of the colonoscope has been evaluated in Japan for improving the detection of polyps and cecal intubation but has not been formally evaluated in the US and other western countries. In one study (19), the polyp detection rate was higher with the transparent cap compared to no cap (49% vs. 39%, p=0.04). Also, the cecal intubation time was shorter with the cap (11.5 min vs 14 min, p=0.008). In a recently published study, a variation of the cap called the transparent retractable extension device was used (21). Overall, the number of adenomas detected were significantly higher with the device compared to without it (205 vs. 150, p=0.04). In an earlier study by Tada et al (22), use of a transparent cap improved the detection rate of lesions per patient (0.86 vs. 0.58) but did not increase the cecal intubation time. Finally, Lee et al (20) used cap assisted colonoscopy in patients with difficult colonoscopy procedure (defined as failure to pass through sigmoid colon after 20 minutes or failure to reach cecum). Using the cap, cecal intubation was achieved in 94% of patients and this proved to be an effective rescue method for failed or difficult colonoscopy. The major appeal of this technique is that it is inexpensive, very practical, and easy to use. Furthermore it is safe and there are no reported complications from this. If found to be effective in increasing the polyp yield it has the potential to being incorporated by busy gastroenterologists in their day to day clinical practice. These features and the preliminary data from Japan merit the evaluation of this promising technique in the US.
Detailed description
The investigators hypothesize that adenoma detection rate will be higher using cap assisted colonoscopy compared to standard colonoscopy. Also, cap assisted colonoscopy will be safe and cecal intubation rate will be similar compared to standard colonoscopy.
Specific Aim 1 - To compare the prevalence of adenomas detected by standard colonoscopy and cap assisted colonoscopy.
Specific Aim 2 - To compare the number of adenomas detected per subject by standard colonoscopy and cap assisted colonoscopy.
Specific aim 3 - To compare the cecal intubation rate, insertion time, withdrawal time and complications of standard colonoscopy and cap assisted colonoscopy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cap arm | Active comparator | Device: Cap - Transparent retractable extension device. |
| Standard arm | Active comparator | Device: Standard |
Who may qualify
- Ages
- 21 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Referral for screening and/or surveillance colonoscopy and the ability to provide informed consent.
Key exclusion criteria (8 listed)
- prior surgical resection of any portion of colon,
- prior history of colon cancer,
- history of inflammatory bowel disease,
- use of anti-platelet agents or anticoagulants that precludes removal of polyps during the procedure,
- poor general condition or any other reason to avoid prolonged procedure time
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cap - Transparent retractable extension device.Also: Cap Assisted ColonoscopyAttaching a Cap - Transparent retractable extension device. | Device | Cap arm |
| StandardAlso: Standard ColonoscopyWithout attaching a transparent cap to the tip of colonoscope. | Device | Standard arm |
Primary outcome
The primary outcome is the prevalence of adenomas in the two groups.
Time frame: 2 years
1 secondary outcome
The secondary outcomes are the number of adenomas detected per subject, cecal intubation rate, insertion times, withdrawal times and complication rates in the two arms.
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2010.
- Derived from this study: PubMed 21997547Rastogi A, Bansal A, Rao DS, Gupta N, Wani SB, Shipe T, Gaddam S, Singh V, Sharma P. Higher adenoma detection rates with cap-assisted colonoscopy: a randomised controlled trial. Gut. 2012 Mar;61(3):402-8. doi: 10.1136/gutjnl-2011-300187. Epub 2011 Oct 13.
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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.
Amit Rastogi, MD principal investigator
Veterans Affairs Medical Center, Kansas City, MO
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cap - Transparent retractable extension device. and Standard in people with Adenoma and Colon Polyps, run by American Society for Gastrointestinal Endoscopy 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 1 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: status not confirmed, as of the sponsor's last update on 29 Sep 2010. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Deepthi S Rao, MBBS (816-861-4700 ext. 56428, Deepthi.Rao@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome is the prevalence of adenomas in the two groups. (time frame: 2 years). 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 NCT01211132, which also lists 1 linked publication.
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 29 Sep 2010.