NCT05943288

Brief Summary

This is a prospective, multicenter, randomized Trial to assess the safety and efficacy of the Olympus Endoscopy Computer-Aided Detection (CADe) system, OIP-1, in the detection of colorectal neoplasia's during real-time colonoscopy. The aim of this system is to improve physician performance in the detection of potential mucosal abnormalities during colonoscopy performed for primary Colorectal Cancer screening or postpolypectomy surveillance.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
850

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2023

Geographic Reach
4 countries

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 25, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 7, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 13, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2024

Completed
Last Updated

March 18, 2025

Status Verified

March 1, 2025

Enrollment Period

1.3 years

First QC Date

June 7, 2023

Last Update Submit

March 17, 2025

Conditions

Colorectal Cancer

Keywords

AI (Artificial Intelligence)CADe (Endoscopy Computer Aided Detection)

Outcome Measures

Primary Outcomes (2)

  • Adenoma Detection Rate (ADR)

    Proportion of patients with at least one histologically confirmed adenoma (including advanced adenomas) or carcinoma in the CADe assisted colonoscopy (CADe+ arm) versus conventional colonoscopy without CAD (CADe- arm).

    During procedure

  • Positive Predictive Value (PPV)

    Number of histologically confirmed polyps (i.e. adenomas, SSLs, or large (\>10mm) hyperplastic polyps divided by the total number of resections.

    During procedure

Secondary Outcomes (3)

  • Adenoma Per Colonoscopy (APC)

    During procedure

  • Total Procedure Time

    During procedure

  • Endoscope withdrawal time

    During procedure

Other Outcomes (2)

  • Adverse events (AEs)

    During procedure

  • Non-neoplastic resection rate

    During procedure

Study Arms (2)

CADe +

Olympus Endoscopy Computer-Aided Detection (CADe) system

Device: OIP-1

CADe -

Standard of Care Endoscopy (HD Whitelight)

Interventions

OIP-1DEVICE

Olympus Endoscopy Computer-Aided Detection (CADe) system

CADe +

Eligibility Criteria

Age45 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Subjects undergoing a colonoscopy

You may qualify if:

  • Signed informed consent
  • years
  • Undergoing colonoscopy for primary CRC screening or postpolypectomy surveillance

You may not qualify if:

  • Lack of informed written consent
  • History of CRC or inflammatory bowel disease or polyposis syndrome / familial adenomatous polyposis coli (FAP)
  • Prior failed colonoscopy
  • multiple historic prior failed colonoscopy due to poor bowel preparation OR
  • a single prior failed colonoscopy due to reasons other than poor bowel preparation
  • Biopsy/anesthesia/sedation contraindications
  • History of radio- and/or chemotherapy
  • Concurrent participation in another competing clinical study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

ZU Leuven

Leuven, 3000, Belgium

Location

Evangelisches Krankenhaus Düsseldorf

Düsseldorf, 40217, Germany

Location

Universitätsklinikum Ulm

Ulm, 89081, Germany

Location

Fundación Biomédica Galicia Sur

Pontevedra, 36071, Spain

Location

Hospital Universitari I Politécnic La Fe

Valencia, 46026, Spain

Location

Linköping Universitetssjukhus

Linköping, 58185, Sweden

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Karolin Boecker

    Olympus Europa SE & Co. KG

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 7, 2023

First Posted

July 13, 2023

Study Start

April 25, 2023

Primary Completion

July 31, 2024

Study Completion

July 31, 2024

Last Updated

March 18, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

DE(2)SE(1)ES(2)BE(1)