Artificial Intelligence in Colonic Polyp Detection

NCT ID: NCT05178095

Last Updated: 2023-06-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-30

Study Completion Date

2023-06-01

Brief Summary

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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.

Detailed Description

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Conditions

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Polyp of Colon Adenoma Colon Gastrointestinal Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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AI

Colonoscopy with AI

Group Type EXPERIMENTAL

Artificial intelligence

Intervention Type DEVICE

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

No AI

Colonoscopy without AI

Group Type PLACEBO_COMPARATOR

No Artificial Intelligence

Intervention Type DEVICE

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

Interventions

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Artificial intelligence

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

Intervention Type DEVICE

No Artificial Intelligence

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* All patients without IBD referred for colonoscopy

Exclusion Criteria

* Age \< 40 years
* Not willing to participate
Minimum Eligible Age

40 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sahlgrenska University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Per Hedenström

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Björn Lindkvist

Role: STUDY_DIRECTOR

Sahlgrenska University Hospital

Locations

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Dr Per Hedenström

Gothenburg, , Sweden

Site Status

Countries

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Sweden

References

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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.

Reference Type DERIVED
PMID: 38290758 (View on PubMed)

Other Identifiers

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Dnr 2020-01951

Identifier Type: -

Identifier Source: org_study_id

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