Thinking of joining a study?

Register your interest

Become a volunteer?

NCT05869838 | Recruiting | Colonic Polyp

A Clinical Study on Endoscopic and Histopathological Outcomes of Screening and Surveillance Colonoscopies
Sponsor:

Olympus Europe SE & Co. KG

Brief Summary:

The objective of this study is to collect colonoscopy data for use in the development and testing of artificial intelligence (AI) devices for colonoscopies.

Condition or disease

Colonic Polyp

Intervention/treatment

Colonoscopy

Detailed Description:

The primary objective of this study is to collect colonoscopy data for use in the development and performance evaluation of AI devices. The data will be collected during routine colonoscopy procedures. Biopsy or resection will be performed if needed and all specimens will be sent for histopathological examination. The histopathological results will be recorded.}}

Study Type : Observational
Estimated Enrollment : 600 participants
Official Title : Collecting Real-world Data on Endoscopic and Histopathological Outcomes of Screening and Surveillance Colonoscopies for the Development of a CAD (Computer Aided Detection) System: A Prospective, Multicenter, Post-market Investigation
Actual Study Start Date : March 12, 2024
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : December 31, 2024

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria
  • Patients aged 18 years or older
  • Patients who have signed a written consent form from their voluntary decision after receiving thorough explanation on this study and fully understanding the explanation prior to participation in the study
  • Patients who plan to receive colonoscopy procedure and meet any of the following conditions: Colon cancer screening, post-polypectomy surveillance, patients who are advised by a physician to take a colonoscopy exam
Exclusion Criteria
  • Patients for whom endoscopic submucosal dissection is planned
  • Patients for whom polypectomy is difficult to perform due to antithrombotic therapy received etc.
  • Patients who have to receive an urgent colonoscopy procedure
  • Patients who underwent total colectomy of the large intestine
  • Patients who are judged by a physician to be contraindicated for colonoscopy procedures
  • Patients who have participated in another clinical study within the last 30 days
A Clinical Study on Endoscopic and Histopathological Outcomes of Screening and Surveillance Colonoscopies

Location Details

Please Choose a site

A Clinical Study on Endoscopic and Histopathological Outcomes of Screening and Surveillance Colonoscopies

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Recruiting

Germany,

Hanover End and Colon Center

Hannover, Germany,

Not yet recruiting

Spain,

Ramón y Cajal University Hospital

Madrid, Spain,

Not yet recruiting

Sweden,

First Hospital Stockholm

Stockholm, Sweden,