AdenomaNCT01601431
The Utility of Cap Colonoscopy in Increasing Adenoma Detection Rate
A study testing Cap Assisted Colonoscopy and Conventional colonoscopy in people with Adenoma, run by Texas Tech University Health Sciences Center, El Paso at 1 site in United States.
Trial summary
This is a research study about the usefulness of transparent cap during screening colonoscopy. The purpose of the research is to test the usefulness of adding small cap to the tip of the colonoscope. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Adenoma
- What is being tested?
- Cap Assisted Colonoscopy and Conventional colonoscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 440 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Mar 2012to 2 Feb 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult Hispanic patients (18-80) who are undergoing colonoscopy for screening or surveillance purposes.
Who cannot join
- Patients younger than 18 yrs old or older than 80 yrs.
- Patients with a prior history of colonic surgeries
- Patient with Crohns colitis or ulcerative colitis.
- Patient with prior history of colon cancer
- Patient with poor bowel preparation
Trial locations and contacts
1 site in 1 country.
United States1 site
Texas Tech University Health Sciences Center at El Paso
El Paso, Texas, 79905
About this study
This is a research study about the usefulness of transparent cap during screening colonoscopy. The purpose of the research is to test the usefulness of adding small cap to the tip of the colonoscope. the investigators hypothesis is that Cap assisted colonoscopy will improve the detection of adenomatous polyps (polyps which can become colon cancer later on) in comparison to the standard colonoscopy.
Read the detailed description
This is a prospective, randomized trial comparing the adenoma detection rate between Hispanic patients undergoing a screening colonoscopy with a conventional colonoscope or with a cap-assisted colonoscopy. The aims of the study are:
- Compare ADR between Hispanic patients undergoing a screening colonoscopy with and without cap.
- Compare the overall polyp detection rate between Hispanic patients undergoing a screening colonoscopy with and without cap.
- Compare the cecal intubation rate and cecal intubation time between standard colonoscopy and cap assisted colonoscopy.
- Compare the complication rate between standard colonoscopy and cap assisted colonoscopy.
- Conditions
- Adenoma
- Being tested
- Cap Assisted Colonoscopy, Conventional colonoscopy
- Keywords
- Screening colonoscopy
- Medical subject headings
- Adenoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cap Assisted ColonoscopyDevice
Plastic transparent cap added to the distal end of the colonoscope which can increase adenoma detection rate
Conventional colonoscopyDevice
Regular colonoscopy as per standard clinical guidelines
| Study group | Role | What they receive |
|---|---|---|
| Cap Assisted Colonoscopy | Experimental | Cap Assisted Colonoscopy uses a Cap which is a transparent hood which is attached to the distal end of the colonscope and allows depressing the colon folds in order to visualize hidden polyps behind the folds. Receives: Device: Cap Assisted Colonoscopy |
| Conventional colonoscopy | Active comparator | A conventional colonoscopy does not use a Cap in order to perform the procedure Receives: Device: Conventional colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
ADR Differences in Hispanic Patients Undergoing a Screening Colonoscopy With and Without Cap.
- Compare ADR between Hispanic patients undergoing a screening colonoscopy with and without cap.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2012 (estimated)
- Study start29 Mar 2012
- Primary completion2 Feb 2015
- Study completion2 Feb 2015
Why it stopped: Study was inactivated by the IRB since PI left institution.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 440 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Tech University Health Sciences Center, El Paso
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed O Othman, Texas Tech University Health Sciences Center, El Paso
- Investigators
- Mohamed O Othman, MD, Principal investigator, Texas Tech University Health Sciences Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01601431
- Sponsor's protocol ID
- E12050
- Status last verified
- May 2018
- First submitted
- 14 May 2012
- Last updated
- 7 Jun 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Utility of Cap Colonoscopy in Increasing Adenoma Detection Rate
- ClinicalTrials.gov ID
- NCT01601431
- Acronym / sponsor ID
- E12050
- Conditions
- Adenoma
- Keywords
- Screening colonoscopy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was inactivated by the IRB since PI left institution.
- Enrolment
- 440 participants (actual)
- Lead sponsor
- Texas Tech University Health Sciences Center, El PasoUniversity, hospital or other
- Study start
- 29 Mar 2012 (actual)
- Primary completion
- 2 Feb 2015 (actual)
- Study completion
- 2 Feb 2015 (actual)
- First posted
- 18 May 2012 (estimated)
- Results
- Posted 7 Jun 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a research study about the usefulness of transparent cap during screening colonoscopy. The purpose of the research is to test the usefulness of adding small cap to the tip of the colonoscope. the investigators hypothesis is that Cap assisted colonoscopy will improve the detection of adenomatous polyps (polyps which can become colon cancer later on) in comparison to the standard colonoscopy.
Detailed description
This is a prospective, randomized trial comparing the adenoma detection rate between Hispanic patients undergoing a screening colonoscopy with a conventional colonoscope or with a cap-assisted colonoscopy. The aims of the study are:
- Compare ADR between Hispanic patients undergoing a screening colonoscopy with and without cap.
- Compare the overall polyp detection rate between Hispanic patients undergoing a screening colonoscopy with and without cap.
- Compare the cecal intubation rate and cecal intubation time between standard colonoscopy and cap assisted colonoscopy.
- Compare the complication rate between standard colonoscopy and cap assisted colonoscopy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cap Assisted Colonoscopy | Experimental | Device: Cap Assisted ColonoscopyCap Assisted Colonoscopy uses a Cap which is a transparent hood which is attached to the distal end of the colonscope and allows depressing the colon folds in order to visualize hidden polyps behind the folds. |
| Conventional colonoscopy | Active comparator | Device: Conventional colonoscopyA conventional colonoscopy does not use a Cap in order to perform the procedure |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult Hispanic patients (18-80) who are undergoing colonoscopy for screening or surveillance purposes.
Key exclusion criteria (5 listed)
- Patients younger than 18 yrs old or older than 80 yrs.
- Patients with a prior history of colonic surgeries
- Patient with Crohns colitis or ulcerative colitis.
- Patient with prior history of colon cancer
- Patient with poor bowel preparation
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 Assisted ColonoscopyPlastic transparent cap added to the distal end of the colonoscope which can increase adenoma detection rate | Device | Cap Assisted Colonoscopy |
| Conventional colonoscopyRegular colonoscopy as per standard clinical guidelines | Device | Conventional colonoscopy |
Primary outcome
ADR Differences in Hispanic Patients Undergoing a Screening Colonoscopy With and Without Cap.
Time frame: 1 year
1. Compare ADR between Hispanic patients undergoing a screening colonoscopy with and without cap.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Mohamed O Othman, MD principal investigator
Texas Tech University Health Sciences Center
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 Assisted Colonoscopy and Conventional colonoscopy in people with Adenoma, run by Texas Tech University Health Sciences Center, El Paso 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 5 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: stopped early, as of the sponsor's last update on 7 Jun 2018. 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?
Yes. Results are posted in the registry (first posted 7 Jun 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
ADR Differences in Hispanic Patients Undergoing a Screening Colonoscopy With and Without Cap. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Jun 2018.