Study of bladdeR Cancer Detection in Standard White Light Versus AI-Supported Endoscopy-02

NCT ID: NCT06780358

Last Updated: 2025-01-17

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

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-20

Study Completion Date

2025-05-31

Brief Summary

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This study is being conducted to investigate if an artificial intelligence support tool is non-inferior in detecting bladder cancer compared to the traditional method, standard white light cystoscopy (WLC). The researchers will compare how well the artificial intelligence tool and WLC perform in detecting bladder cancer through a controlled, organized testing process.

Detailed Description

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This clinical investigation aims to confirm that an artificial intelligence model utilizing a Convolutional Neural Network (CNN) can achieve sensitivity in detecting bladder cancer that is non-inferior to traditional white light cystoscopy (WLC) in a randomized controlled trial. The investigational artificial intelligence device leverages the advanced capabilities of CNNs, a type of deep learning model designed to analyze visual imagery with high precision.

Conditions

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Bladder Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Premarket Confirmatory, National, single-center, randomized, prospective, non-inferiority trial
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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WLC detection

Detection of bladder cancer is conducted according to state-of-the-art procedures in white light modality.

Group Type NO_INTERVENTION

No interventions assigned to this group

AI model - WLC supported detection

Detection of bladder cancer in white light supported by a pre-market AI-support tool.

Group Type EXPERIMENTAL

AI supported detection of bladder cancer

Intervention Type DEVICE

AI-model-supported detection of bladder cancer during white light cystoscopy

Interventions

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AI supported detection of bladder cancer

AI-model-supported detection of bladder cancer during white light cystoscopy

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Men and women adults, age \>18 years old

Suspicion of primary or recurrent bladder cancer

Willingness to sign the Informed Consent Form (ICF) for the CI

Ability to comprehend the oral and written Patient Information Leaflet (PIL)

Exclusion Criteria

* Not able or willing to sign the Informed Consent Form
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aarhus University Hospital

OTHER

Sponsor Role collaborator

Cystotech

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jakobsen

Role: PRINCIPAL_INVESTIGATOR

Department of Urology, Aarhus University Hospital, denmark

Locations

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Department of Urology, Aarhus University Hospital

Aarhus, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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RAISE02-24-02

Identifier Type: -

Identifier Source: org_study_id

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