Colon AdenomaKoloPol INCT02838888
Computer-assisted Detection of Colonic Polyps
An observational study of Colon Adenoma, run by Technical University of Munich at 1 site in Germany.
Trial summary
Screening colonoscopy is considered the gold standard for adenoma detection in the colon. However, it has been shown that a considerable number of polyps can be missed during screening colonoscopy. Until now the endoscopist himself is responsible for the detection of adenomatous polyps. Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Colon Adenoma
- What is being tested?
- Automatic polyp detection software
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2016to Aug 2017
- 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 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients receiving colonoscopy at the study site are eligible for participation.
Who may be able to join
- Indication for colonoscopy
- age ≥ 40 years
Who cannot join
- American Society of Anesthesiologists class IV or higher
- pregnant women
- indication for colonoscopy: inflammatory bowel disease
- indication for colonoscopy: polyposis syndrome
- indication for colonoscopy: emergency colonoscopy e.g. acute bleeding
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
II Medizinische Klinik am Klinikum rechts der Isar der Technischen Universität München
Munich, Bavaria, 81675
Peter Klare, MD, + 49 89 4140 ext. 9340, peter.klare@tum.de
Stefan von Delius, Prof., + 49 89 4140 ext. 5973, stefan_ruckert@yahoo.de
About this study
Screening colonoscopy is considered the gold standard for adenoma detection in the colon. However, it has been shown that a considerable number of polyps can be missed during screening colonoscopy. Until now the endoscopist himself is responsible for the detection of adenomatous polyps. No automatic tools are available supporting the colonoscopist to detect lesions. Recently, a computer program was developed that can be used to recognize and extract suspicious structure from colonoscopy video sequences. The program was built to automatically detected colonic polyps and to highlight the polyps by colour marking. The program was now refined so that the respective structures can be highlighted during real time colonoscopy. The aim of this feasibility study is to test whether the software is applicable during real time colonoscopy.
- Conditions
- Colon Adenoma
- Being tested
- Automatic polyp detection software
- Keywords
- Adenoma, computer, automatic, polyp, detection
- Medical subject headings
- Adenoma, Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Automatic polyp detection softwareDevice
A computer program for the detection of colonic polyps will be used during colonoscopy
| Study group | Role | What they receive |
|---|---|---|
| Routine colonoscopy Cohort | Patients receiving routine colonoscopy at the study site Receives: Device: Automatic polyp detection software |
What is being measured
The primary outcome is the main question the study is designed to answer.
Polyp detection
After obtaining the histopathological diagnosis of resected polyps (approximately 3 days - 2 weeks) it can be determined whether the resected specimen contained polyp histology or not.
Measured: up to 2 weeks (participants will be followed for the duration of hospital stay or outpatient treatment, an expected average of 2 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2016 (estimated)
- Study startJul 2016
- Primary completionDec 2016
- Study completionAug 2017 (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 Colon 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Collaborators
- Fraunhofer Institut Erlangen
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02838888
- Sponsor's protocol ID
- KoloPol I
- Acronym
- KoloPol I
- Status last verified
- Apr 2017
- First submitted
- 18 Jul 2016
- Last updated
- 11 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Klare P, Sander C, Prinzen M, Haller B, Nowack S, Abdelhafez M, Poszler A, Brown H, Wilhelm D, Schmid RM, von Delius S, Wittenberg T. Automated polyp detection in the colorectum: a prospective study (with videos). Gastrointest Endosc. 2019 Mar;89(3):576-582.e1. doi: 10.1016/j.gie.2018.09.042. Epub 2018 Oct 17.
PubMed 30342029
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computer-assisted Detection of Colonic Polyps
- ClinicalTrials.gov ID
- NCT02838888
- Acronym / sponsor ID
- KoloPol I / KoloPol I
- Conditions
- Colon Adenoma
- Keywords
- Adenoma, computer, automatic, polyp, detection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Collaborators
- Fraunhofer Institut Erlangen
- Study start
- Jul 2016
- Primary completion
- Dec 2016 (actual)
- Study completion
- Aug 2017 (estimated)
- First posted
- 20 Jul 2016 (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.
Screening colonoscopy is considered the gold standard for adenoma detection in the colon. However, it has been shown that a considerable number of polyps can be missed during screening colonoscopy. Until now the endoscopist himself is responsible for the detection of adenomatous polyps. No automatic tools are available supporting the colonoscopist to detect lesions. Recently, a computer program was developed that can be used to recognize and extract suspicious structure from colonoscopy video sequences. The program was built to automatically detected colonic polyps and to highlight the polyps by colour marking. The program was now refined so that the respective structures can be highlighted during real time colonoscopy. The aim of this feasibility study is to test whether the software is applicable during real time colonoscopy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Routine colonoscopy Cohort | – | Device: Automatic polyp detection softwarePatients receiving routine colonoscopy at the study site |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients receiving colonoscopy at the study site are eligible for participation.
Key inclusion criteria (2 listed)
- Indication for colonoscopy
- age ≥ 40 years
Key exclusion criteria (5 listed)
- American Society of Anesthesiologists class IV or higher
- pregnant women
- indication for colonoscopy: inflammatory bowel disease
- indication for colonoscopy: polyposis syndrome
- indication for colonoscopy: emergency colonoscopy e.g. acute bleeding
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 |
|---|---|---|
| Automatic polyp detection softwareA computer program for the detection of colonic polyps will be used during colonoscopy | Device | Routine colonoscopy Cohort |
Primary outcome
Polyp detection
Time frame: up to 2 weeks (participants will be followed for the duration of hospital stay or outpatient treatment, an expected average of 2 weeks)
After obtaining the histopathological diagnosis of resected polyps (approximately 3 days - 2 weeks) it can be determined whether the resected specimen contained polyp histology or not.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2017.
- Derived from this study: PubMed 30342029Klare P, Sander C, Prinzen M, Haller B, Nowack S, Abdelhafez M, Poszler A, Brown H, Wilhelm D, Schmid RM, von Delius S, Wittenberg T. Automated polyp detection in the colorectum: a prospective study (with videos). Gastrointest Endosc. 2019 Mar;89(3):576-582.e1. doi: 10.1016/j.gie.2018.09.042. Epub 2018 Oct 17.
- 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.
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 Colon Adenoma, run by Technical University of Munich 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: status not confirmed, as of the sponsor's last update on 11 Apr 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Peter Klare, MD (+ 49 89 4140 ext. 9340, peter.klare@tum.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Polyp detection (time frame: up to 2 weeks (participants will be followed for the duration of hospital stay or outpatient treatment, an expected average of 2 weeks)). 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 NCT02838888, 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 11 Apr 2017.