ColoReg: A Register for Gastrointestinal Endoscopy Reports and Examination Videos
NCT ID: NCT06920680
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
1834 participants
OBSERVATIONAL
2024-10-01
2027-10-31
Brief Summary
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Furthermore, the investigators want to make the findings and video data accessible to the scientific community. Since scientific studies rarely publish raw data for this purpose, there is currently no large and constantly updated database of findings, images, and videos. If a study requires such data, new data must be collected with great organizational and financial effort. As a result, different studies are only partially comparable, and their significance is reduced.
By publishing the data, a valuable information source for medical professionals in training, continuing education, and advanced training is created. Researchers also benefit from this data: New technologies, such as image analysis software, can be tested and compared on a consistent basis. Therefore, participation in this study makes a valuable contribution to the foundation of good medical care: education, research, and quality assurance.
Primary Study Goal:
The study aims to evaluate the effectiveness and safety of different endoscopic resection techniques. Effectiveness is defined as achieving a complete removal of the lesion (R0 resection) or having a clear follow-up in more than 90% of cases. Safety is defined as having less than 3% of cases result in complications like perforation, uncontrollable bleeding, or the need for unplanned follow-up due to issues like interval bleeding or perforation. The target diagnostic accuracy is 95%.
Secondary Study Goals:
1. Ensure that in 90% of cases, the recommended follow-up interval aligns with current national guidelines based on the number, size, and histopathology of polyps.
2. Achieve successful retrieval of polyps in more than 95% of cases.
3. Document minor bleedings, defined as continuous bleeding for over 30 seconds that requires clipping.
Tertiary Study Goal:
Develop software that can identify and mask sensitive information (such as names, birth dates, examination dates, and video sections outside the human body) in videos from 1,000 examinations, or flag them for manual review. Similarly, the software should identify and remove sensitive text information in the reports, such as names, birth dates, case numbers, examiners, and phone numbers, or mark the text for manual review.
Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Colonoscopy
All patients recruited in a study center are included.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
Yes
Sponsors
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Robert Bosch Medical Center
OTHER
Krankenhaus Barmherzige Brüder, Regensburg
OTHER
Universitätsklinikum Hamburg-Eppendorf
OTHER
Klinikum Ludwigsburg
OTHER
Wuerzburg University Hospital
OTHER
Responsible Party
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Principal Investigators
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Alexander Meining, Prof.
Role: STUDY_CHAIR
University Hospital Wuerzburg
Locations
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Robert Bosch Krankenhaus
Stuttgart, Baden-Wurttemberg, Germany
University Hospital Würzburg
Würzburg, Bavaria, Germany
Countries
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Central Contacts
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Facility Contacts
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Martin Schich, Dr. med
Role: primary
Thomas J. Lux, Dr. med. M. Sc.
Role: primary
Yvonne Josef
Role: backup
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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151/23-sc
Identifier Type: -
Identifier Source: org_study_id