Ignite Creation Date:
2025-12-25 @ 12:07 AM
Ignite Modification Date:
2026-01-01 @ 9:50 PM
Study NCT ID:
NCT06780358
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-01-17
First Post:
2025-01-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of bladdeR Cancer Detection in Standard White Light Versus AI-Supported Endoscopy-02
Sponsor:
Cystotech
Organization:
Study Overview
Official Title:
Study of bladdeR Cancer Detection in Standard White Light Versus AI-Supported Endoscopy-02
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2025-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RAISE02
Brief Summary:
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:
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: