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NCT Number: NCT06920680

ColoReg: A Register for Gastrointestinal Endoscopy Reports and Examination Videos

With the participants help, the investigators aim to track treatment methods, treatment outcomes, and adverse events, as well as document the treatment strategies used during endoscopic colorectal cancer prevention and treatment. This will allow us to verify if the results from targeted clinical studies and current scientific knowledge are also reflected in the real world. Additionally, the investigators want to use the collected videos and findings to support the training of doctors. During each examination, doctors must be able to accurately assess the inside of the body. Teaching materials for this purpose are scarcely available, often outdated (especially images), and usually show obvious cases. The investigators aim to provide doctors with the opportunity to learn outside of real patient examinations and benefit from the experiences of others.

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Robert Bosch Krankenhaus, Stuttgart, Baden-Wurttemberg, Germany

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Indication for diagnostic or therapeutic colonoscopy

Exclusion criteria

-

Treatment and study plan

Primary outcomes

  1. R0 Resection Rate by Removal Method (lesion size >= 20 mm)

    Time frame: through study completion, an average of 1 year

    Rate of histologically complete resection for removed pre-cancerous and cancerous lesions >= 20 mm.

  2. Inconspicious follow-up by method of Removal (lesion >= 20 mm)

    Time frame: through study completion, an average of 1 year

    Rate of macroscopically endoscopic follow-up examinations within 1 year if performed

  3. Major Complication Rate (lesion size >= 20 mm)

    Time frame: through study completion, an average of 1 year

    Rate of examination related major complications defined as endoscopically uncontrollable bleedings or perforations.

Secondary outcomes

  1. Intervention time by method of removal (>= 20 mm)

    Time frame: through study completion, an average of 1 year

    Time required from discovery of a polyp to completed treatment including handling of immediate complications.

  2. Rate of unforeseen re-examination within 3 months after polypectomie (lesions >= 20 mm)

    Time frame: through study completion, an average of 1 year

    Rate of unforeseen re-examination within 3 months after polypectomie (lesions >= 20 mm)

Study contacts

Contact information is provided by the study sponsor or research team.

Thomas J. Lux, Dr. med. M. Sc.

CONTACT

[email protected]

+49 931 201 40247

Yvonne Josef

CONTACT

[email protected]

+49 931 201 40255

Sponsors and collaborators

Lead sponsor

Wuerzburg University Hospital

Other

Collaborators

  • Klinikum Ludwigsburg
  • Krankenhaus Barmherzige Brüder, Regensburg
  • Robert Bosch Medical Center
  • Universitätsklinikum Hamburg-Eppendorf

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Apr 10, 2025
Registry last updated
Dec 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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