Colorectal PolypsNCT01515514
Confocal Endomicroscopy for GI Neoplasia Study
An observational study of Colorectal Polyps, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is to enhance probe stabilization using a 4mm clear cap attached to endoscope in comparison to standard "free-hand" image acquisition. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colorectal Polyps
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Nov 2012
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Approximately 40 patients with polyps
Who may be able to join
- Those patients undergoing colonoscopy for screening or surveillance of colon polyps will be included in this study.
Who cannot join
- Patients with known polyposis syndromes, inflammatory bowel disease, allergy to fluorescein, or refusal to provide informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to enhance probe stabilization using a 4mm clear cap attached to endoscope in comparison to standard "free-hand" image acquisition.
Read the detailed description
The aim of this study is to optimize and validate in-vivo imaging systems capable of highly accurate, real-time classification of colorectal neoplasia.
- Conditions
- Colorectal Polyps
- Keywords
- polyps, inflammatory bowel disease, associated neoplasia
- Medical subject headings
- Polyps, Inflammatory Bowel Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of the confocal image
Quality will be assessed subjectively. Subjective technical quality of each video sequence will be scored by two independent experts.
Measured: 1 yr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2012 (estimated)
- Study startAug 2012
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal PolypsStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Bankhead-Coley
- Responsible party
- Principal investigator, Michael Wallace, Mayo Clinic
- Investigators
- Michael B Wallace, MD,MPH, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01515514
- Sponsor's protocol ID
- 11-006327
- Status last verified
- May 2013
- First submitted
- 10 Jan 2012
- Last updated
- 17 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Confocal Endomicroscopy for GI Neoplasia Study
- ClinicalTrials.gov ID
- NCT01515514
- Acronym / sponsor ID
- 11-006327
- Conditions
- Colorectal Polyps
- Keywords
- polyps, inflammatory bowel disease, associated neoplasia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Bankhead-Coley
- Study start
- Aug 2012
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 24 Jan 2012 (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.
The purpose of this study is to enhance probe stabilization using a 4mm clear cap attached to endoscope in comparison to standard "free-hand" image acquisition.
Detailed description
The aim of this study is to optimize and validate in-vivo imaging systems capable of highly accurate, real-time classification of colorectal neoplasia.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Approximately 40 patients with polyps
Key inclusion criteria (1 listed)
- Those patients undergoing colonoscopy for screening or surveillance of colon polyps will be included in this study.
Key exclusion criteria (1 listed)
- Patients with known polyposis syndromes, inflammatory bowel disease, allergy to fluorescein, or refusal to provide informed consent.
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
Quality of the confocal image
Time frame: 1 yr
Quality will be assessed subjectively. Subjective technical quality of each video sequence will be scored by two independent experts.
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 17 May 2013.
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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.
Michael B Wallace, MD,MPH principal investigator
Mayo Clinic
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 Colorectal Polyps, run by Mayo Clinic 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 1 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 17 May 2013. 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?
Quality of the confocal image (time frame: 1 yr). 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 17 May 2013.