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

NCT05869838 | Completed

• 1 other identifier: 2023-001
• Study Type: observational
• Target: 600
• Locations: 2 countries
• Sites: 2

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.

Conditions

Colonic Polyp

Outcome Measures

Primary Outcomes (1)

• Videos and still images of the colonoscopy

  Narrow band imaging (NBI) images and white-light images, video recordings of the colonoscopy

  during the procedure

Interventions

Colonoscopy DEVICE

Screening or surveillance colonoscopy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing screening or surveillance colonoscopy

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Olympus Europe SE & Co. KG: lead

Study Sites (2)

End- und Dickdarmzentrum Hannover

Hanover, Germany

Location

Hospital Universitario Ramón y Cajal

Madrid, Spain

Location

MeSH Terms

Conditions

Colonic Polyps

Interventions

Colonoscopy

Condition Hierarchy (Ancestors)

Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Sofía Parejo Carbonell

  Hospital Universitario Ramón y Cajal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2023
• First Posted: May 22, 2023
• Study Start: March 12, 2024
• Primary Completion: October 30, 2025
• Study Completion: October 30, 2025
• Last Updated: March 6, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1); ES (1)