NCT05740137

Brief Summary

The goal of this quasi randomized multicenter controlled clinical trial (RCT) is to investigate whether a combined real time computer-aided polyp detection (CADe) and computer-aided polyp characterization (CADx) system (GI Genius, Medtronic) can increase the adenoma detection rate (ADR) and reduce the performance variability among endoscopists. Participants will be randomized (1:1) to either receive an AI-assisted colonoscopy (AIC) or a conventional colonoscopy (CC). If there is a comparison group: Researchers will compare the AIC-group and the CC-group to see if AIC can increase the ADR significantly.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
795

participants targeted

Target at P75+ for not_applicable colorectal-cancer

Timeline
Completed

Started Oct 2022

Shorter than P25 for not_applicable colorectal-cancer

Geographic Reach
1 country

4 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

October 1, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 3, 2023

Completed
19 days until next milestone

First Posted

Study publicly available on registry

February 22, 2023

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 3, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 3, 2023

Completed
Last Updated

March 6, 2025

Status Verified

September 1, 2024

Enrollment Period

5 months

First QC Date

February 3, 2023

Last Update Submit

March 5, 2025

Conditions

Colorectal CancerColorectal AdenomaColorectal Neoplasms

Keywords

Artificial intelligence-assisted colonoscopyComputer-aided polyp detectionColorectal adenoma

Outcome Measures

Primary Outcomes (1)

  • Adenoma detection rate (ADR)

    ADR = (number of examinations with adenomas/total number of examinations) × 100.

    5 Months

Secondary Outcomes (6)

  • Polyp detection rate (PDR)

    5 Months

  • Adenomas per colonoscopy (APC)

    5 Months

  • Polyps per colonoscopy (PPC)

    5 Months

  • Duration of the procedure

    5 Months

  • Non-neoplastic resection rate (NNRR)

    5 Months

  • +1 more secondary outcomes

Study Arms (2)

Control

NO INTERVENTION

Conventional colonoscopy, without AI-assistance.

AI-assisted colonoscopy

ACTIVE COMPARATOR

AI-assisted colonoscopy (AIC) using a computer-aided polyp detection and characterization (CADe and CADx) system.

Device: AI-assisted colonoscopy

Interventions

AI-assisted colonoscopyDEVICE

The patients in the intervention group will receive an AI-assisted colonoscopy (AIC) using the computer-aided polyp detection and characterization (CADe and CADx) GI Genius (Medtronic).

AI-assisted colonoscopy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Referred for screening colonoscopy due to a positive faecal immunochemical test (FIT) or for
  • Diagnostic colonoscopy due to symptoms/signs or
  • Post-polypectomy surveillance colonoscopy (only patients who had all detected polyps removed in the previous colonoscopy)

You may not qualify if:

  • Referral for removal of previous detected polyps
  • Emergency colonoscopy
  • Control colonoscopy due to inflammatory bowel disease (IBD)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Holbæk Hospital

Holbæk, 4300, Denmark

Location

Zealand University Hospital

Køge, 4600, Denmark

Location

Nykøbing Falster County Hospital

Nykøbing Falster, 4800, Denmark

Location

Næstved Hospital

Næstved, 4700, Denmark

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

  • Ronja Lagström, MD

    Zealand University Hospital, Køge

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: A quasi randomized controlled multicenter study
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor, DMSc

Study Record Dates

First Submitted

February 3, 2023

First Posted

February 22, 2023

Study Start

October 1, 2022

Primary Completion

March 3, 2023

Study Completion

March 3, 2023

Last Updated

March 6, 2025

Record last verified: 2024-09

Locations

DK(4)