NCT05178095

Brief Summary

A randomized, controlled study investigating the potential benefits of artificial intelligence (AI) in the detection of colonic polyps during outpatient colonoscopy. Randomization between the use of AI and no AI is performed before the study procedure.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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

September 30, 2020

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

November 15, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 5, 2022

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

June 28, 2023

Status Verified

June 1, 2023

Enrollment Period

2.7 years

First QC Date

November 15, 2021

Last Update Submit

June 27, 2023

Conditions

Polyp of ColonAdenoma ColonGastrointestinal Neoplasms

Keywords

colonoscopyartificial intelligence

Outcome Measures

Primary Outcomes (1)

  • ADR

    Adenoma detection rate

    1 hour

Secondary Outcomes (2)

  • APC

    1 hour

  • Procedural time

    1 hour

Study Arms (2)

AI

EXPERIMENTAL

Colonoscopy with AI

Device: Artificial intelligence

No AI

PLACEBO COMPARATOR

Colonoscopy without AI

Device: No Artificial Intelligence

Interventions

Artificial intelligenceDEVICE

Colonoscopy with the aid of artificial intelligence for the detection of colonic polyps

AI
No Artificial IntelligenceDEVICE

Colonoscopy without the aid of artificial intelligence for the detection of colonic polyps

No AI

Eligibility Criteria

Age40 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients without IBD referred for colonoscopy

You may not qualify if:

  • Age \< 40 years
  • Not willing to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr Per Hedenström

Gothenburg, S-413 45, Sweden

Location

Related Publications (1)

  • Scholer J, Alavanja M, de Lange T, Yamamoto S, Hedenstrom P, Varkey J. Impact of AI-aided colonoscopy in clinical practice: a prospective randomised controlled trial. BMJ Open Gastroenterol. 2024 Jan 30;11(1):e001247. doi: 10.1136/bmjgast-2023-001247.

    PMID: 38290758DERIVED

MeSH Terms

Conditions

Colonic PolypsGastrointestinal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal PolypsPolypsPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal Diseases

Study Officials

  • Björn Lindkvist

    Sahlgrenska University Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 15, 2021

First Posted

January 5, 2022

Study Start

September 30, 2020

Primary Completion

June 1, 2023

Study Completion

June 1, 2023

Last Updated

June 28, 2023

Record last verified: 2023-06

Locations

SE(1)