Colorectal PolypNCT03118856
Electronic Chromoendoscopy for Polyp Characterization
An observational study of Colorectal Polyp, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
Trial summary
To assess the accuracy of predicting histology of colorectal polyps with electronic chromoendoscopy. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Polyp
- What is being tested?
- Prediction of Histology
- How many people
- 230 participants
- Where
- 1 siteGermany
- Study dates
- 1 Feb 2017to 31 May 2018
- 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 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients undergoing screening or surveillance colonoscopy
Who may be able to join
- patients undergoing screening or surveillance colonoscopy
- written informed consent
Who cannot join
- inadequate bowel preparation
- polyposis syndromes
- history of colectomy
- use of anticoagulants
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Real-time Assessment of the Histology of Colorectal Polyps Using Electronic Chromoendoscopy
To assess the accuracy of predicting histology of colorectal polyps with electronic chromoendoscopy.
- Conditions
- Colorectal Polyp
- Being tested
- Prediction of Histology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prediction of HistologyDiagnostic test
The accuracy of predicting the histology of colorectal polyps will be assessed with HD-WLE and EC
| Study group | Role | What they receive |
|---|---|---|
| HD-WLE | Intervention: Prediction of polyp histology with HD-WLE Receives: Diagnostic Test: Prediction of Histology | |
| EC | Intervention: Prediction of polyp histology with EC Receives: Diagnostic Test: Prediction of Histology |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of predicting histology with EC
Polyps will be visualized in white-light and the location and size will be noted. Afterwards, electronic chromoendoscopy will be used to visualize and enhance the mucosal vascular pattern and the mucosal surface pattern morphology of the polyp. The endoscopist will then make a real time assessment of each polyp according to size, shape, Paris classification and surface characteristics including pit pattern and mucosal vascular pattern morphology, colour, and type of depression. Further, a level of confidence (high or low) will be made for the real time histology prediction. Finally, all polyps will be removed using standard techniques and processed for pathological evaluation and real time and histological results will be compared.
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 Apr 2017
- Study start1 Feb 2017
- Primary completion28 Feb 2018
- Study completion31 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal PolypStudies of the same condition, open and under way.
- More trials run by University of Erlangen-Nürnberg Medical SchoolThe 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
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Timo Rath, MD, Principal investigator, University Hospital Erlangen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03118856
- Sponsor's protocol ID
- TR-001
- Status last verified
- Sep 2019
- First submitted
- 13 Apr 2017
- Last updated
- 26 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-time Assessment of the Histology of Colorectal Polyps Using Electronic Chromoendoscopy
- ClinicalTrials.gov ID
- NCT03118856
- Acronym / sponsor ID
- TR-001
- Conditions
- Colorectal Polyp
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 28 Feb 2018 (actual)
- Study completion
- 31 May 2018 (actual)
- First posted
- 18 Apr 2017 (actual)
- 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.
To assess the accuracy of predicting histology of colorectal polyps with electronic chromoendoscopy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HD-WLE | – | Diagnostic Test: Prediction of HistologyIntervention: Prediction of polyp histology with HD-WLE |
| EC | – | Diagnostic Test: Prediction of HistologyIntervention: Prediction of polyp histology with EC |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing screening or surveillance colonoscopy
Key inclusion criteria (2 listed)
- patients undergoing screening or surveillance colonoscopy
- written informed consent
Key exclusion criteria (4 listed)
- inadequate bowel preparation
- polyposis syndromes
- history of colectomy
- use of anticoagulants
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 |
|---|---|---|
| Prediction of HistologyThe accuracy of predicting the histology of colorectal polyps will be assessed with HD-WLE and EC | Diagnostic test | EC, HD-WLE |
Primary outcome
Accuracy of predicting histology with EC
Time frame: 1 year
Polyps will be visualized in white-light and the location and size will be noted. Afterwards, electronic chromoendoscopy will be used to visualize and enhance the mucosal vascular pattern and the mucosal surface pattern morphology of the polyp. The endoscopist will then make a real time assessment of each polyp according to size, shape, Paris classification and surface characteristics including pit pattern and mucosal vascular pattern morphology, colour, and type of depression. Further, a level of confidence (high or low) will be made for the real time histology prediction. Finally, all polyps will be removed using standard techniques and processed for pathological evaluation and real time and histological results will be compared.
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 26 Sep 2019.
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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.
Timo Rath, MD principal investigator
University Hospital Erlangen
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 Polyp, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
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 2 inclusion and 4 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 26 Sep 2019. 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 Germany. 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?
Accuracy of predicting histology with EC (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 26 Sep 2019; AzTrials last refreshed its copy on 3 Nov 2026.