Colorectal PolypsNCT02217449
Virtual Chromoendoscopy for Distal Polyps
An observational study of Colorectal Polyps, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
Trial summary
To assess the accuracy of predicting histology with virtual chromoendoscopy for distal colorectal polyps according to the ASGE PIVI statement. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Polyps
- What is being tested?
- Prediction of histology
- How many people
- 230 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2011to Aug 2014
- 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 screeining or surveillance colonoscopy
Who may be able to join
- Written informed consent
- Screening or surveillance colonoscopy
Who cannot join
- history of inflammatory bowel disease
- poor bowel preparation
- colectomy
- anticoagulation
- polyposis syndrome
Trial locations and contacts
1 site in 1 country.
About this study
To assess the accuracy of predicting histology with virtual chromoendoscopy for distal colorectal polyps according to the ASGE PIVI statement.
- Conditions
- Colorectal Polyps
- 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 histologyOther
| Study group | Role | What they receive |
|---|---|---|
| HD | Prediction of histology Receives: Other: Prediction of histology | |
| Virtual Chromoendoscopy | Prediction of histology Receives: Other: Prediction of histology |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectivity of virtual chromoendoscopy
Upon visualization of a polyp in white-light, the location and size (as compared to open biopsy forceps or snare) are noted. Afterwards, virtual chromoendoscopy is used to visualize and enhance the mucosal vascular pattern and the mucosal surface pattern morphology of the polyp. The endoscopist makes 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, the endoscopist is assigning a level of confidence (high or low) to each real time prediction. Afterwards, all polyps are resected using standard techniques and processed for pathological evaluation. Each polyp is assessed by an experienced GI pathologist blinded to the real time prediction of polyp histology. Finally, real time and histological results are compared.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2014 (estimated)
- Study startJan 2011
- Primary completionAug 2014
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 Colorectal PolypsStudies 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
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02217449
- Sponsor's protocol ID
- HN-0010
- Status last verified
- Dec 2020
- First submitted
- 8 Aug 2014
- Last updated
- 14 Dec 2020
- Results posted
- No
Publications
Rath T, Tontini GE, Nagel A, Vieth M, Zopf S, Gunther C, Hoffman A, Neurath MF, Neumann H. High-definition endoscopy with digital chromoendoscopy for histologic prediction of distal colorectal polyps. BMC Gastroenterol. 2015 Oct 22;15:145. doi: 10.1186/s12876-015-0374-3.
PubMed 26493200
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Chromoendoscopy for Distal Polyps
- ClinicalTrials.gov ID
- NCT02217449
- Acronym / sponsor ID
- HN-0010
- Conditions
- Colorectal Polyps
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Study start
- Jan 2011 (actual)
- Primary completion
- Aug 2014 (actual)
- First posted
- 15 Aug 2014 (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.
To assess the accuracy of predicting histology with virtual chromoendoscopy for distal colorectal polyps according to the ASGE PIVI statement.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HD | – | Other: Prediction of histologyPrediction of histology |
| Virtual Chromoendoscopy | – | Other: Prediction of histologyPrediction of histology |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing screeining or surveillance colonoscopy
Key inclusion criteria (2 listed)
- Written informed consent
- Screening or surveillance colonoscopy
Key exclusion criteria (5 listed)
- history of inflammatory bowel disease
- poor bowel preparation
- colectomy
- anticoagulation
- polyposis syndrome
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 histology | Other | HD, Virtual Chromoendoscopy |
Primary outcome
Effectivity of virtual chromoendoscopy
Time frame: 3 years
Upon visualization of a polyp in white-light, the location and size (as compared to open biopsy forceps or snare) are noted. Afterwards, virtual chromoendoscopy is used to visualize and enhance the mucosal vascular pattern and the mucosal surface pattern morphology of the polyp. The endoscopist makes 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, the endoscopist is assigning a level of confidence (high or low) to each real time prediction. Afterwards, all polyps are resected using standard techniques and processed for pathological evaluation. Each polyp is assessed by an experienced GI pathologist blinded to the real time prediction of polyp histology. Finally, real time and histological results are 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 14 Dec 2020.
- Derived from this study: PubMed 26493200Rath T, Tontini GE, Nagel A, Vieth M, Zopf S, Gunther C, Hoffman A, Neurath MF, Neumann H. High-definition endoscopy with digital chromoendoscopy for histologic prediction of distal colorectal polyps. BMC Gastroenterol. 2015 Oct 22;15:145. doi: 10.1186/s12876-015-0374-3.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 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 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: finished, as of the sponsor's last update on 14 Dec 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 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?
Effectivity of virtual chromoendoscopy (time frame: 3 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 NCT02217449, 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 14 Dec 2020.