Ignite Creation Date:
2024-05-06 @ 5:15 PM
Last Modification Date:
2024-10-26 @ 2:25 PM
Study NCT ID:
NCT05244278
Status:
RECRUITING
Last Update Posted:
2023-12-20
First Post:
2022-02-08
Brief Title:
Artificial Intelligence AI Assisted Real-time Adenoma Detection During Colonoscopies
Sponsor:
Centre hospitalier de lUniversité de Montréal CHUM
Organization:
Centre hospitalier de lUniversité de Montréal CHUM
Study Overview
Official Title:
Artificial Intelligence AI Assisted Real-time Adenoma Detection During Colonoscopies
Status:
RECRUITING
Status Verified Date:
2023-12
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:
None
Brief Summary:
This is a pragmatic double-blind randomized controlled trial to evaluate the effect of implementing a CADs system within the routine clinical practice of Canadian healthcare institutions
The main hypothesis of this study is that the ADR in the operating room equipped with the GI genius CADe system will be significantly higher than the ADR in the ordinary operating room
The main hypothesis of this study is that the ADR in the operating room equipped with the GI genius CADe system will be significantly higher than the ADR in the ordinary operating room
Detailed Description:
This trial will be conducted in four centers across Canada All patients who meet the inexclusion criteria can be enrolled The patients personal medical history will be reviewed to verify patient inclusion and exclusion criteria age history of CRC or adenoma comorbid conditions anticoagulation etc
Eligible patients will be randomized 11 stratified per center in two arms
1 Intervention arm patients will be assigned to undergo colonoscopy in a room equipped with the GI genius CAD system
2 Control arm patients will undergo colonoscopy in a room not equipped with the GI genius CADe system
The endoscopists performing the colonoscopies will not be involved in the development and implementation of CADe Additionally they wont be informed of the ongoing trial and will have the option of not using the CADe when available in the room This design aims to mitigate operator biases that may be partly responsible for the observed difference between the CADe performance in randomized controlled trials and the CADe performance in implementation studies
Data will be collected on case report forms CRF after the procedure from the clinical files and the endoscopy reports The data will then be deidentified and transferred to an electronic RedCap database in each institution A research assistant will collect all information and annotations recorded on the patients medical file during the procedure
In the treatment group operating room equipped with the CADe the Medtronic-GI genius system can be used for real-time support by the endoscopists to detect polyps of all sizes Use of CADe is left to the discretion of the treating physician performing the colonoscopy If used CADe will provide real-time feedback throughout each colonoscopy procedure and will alert the endoscopists of the presence of a polyp in the endoscopy field by displaying a bounding box on the same screen
In the control group colonoscopy performed in room without CADe system the participating endoscopists will detect as per standard of care
All colonoscopies in the intervention and control groups including polypectomy procedures will be performed at the discretion of the treating physician and per standard of care
All polyps will be resected and sent to the pathology labs of the participating institutions to be evaluated for histology by board-certified pathologists The histopathology outcomes will be collected and stored in the CRF forms to be used as a reference later
Eligible patients will be randomized 11 stratified per center in two arms
1 Intervention arm patients will be assigned to undergo colonoscopy in a room equipped with the GI genius CAD system
2 Control arm patients will undergo colonoscopy in a room not equipped with the GI genius CADe system
The endoscopists performing the colonoscopies will not be involved in the development and implementation of CADe Additionally they wont be informed of the ongoing trial and will have the option of not using the CADe when available in the room This design aims to mitigate operator biases that may be partly responsible for the observed difference between the CADe performance in randomized controlled trials and the CADe performance in implementation studies
Data will be collected on case report forms CRF after the procedure from the clinical files and the endoscopy reports The data will then be deidentified and transferred to an electronic RedCap database in each institution A research assistant will collect all information and annotations recorded on the patients medical file during the procedure
In the treatment group operating room equipped with the CADe the Medtronic-GI genius system can be used for real-time support by the endoscopists to detect polyps of all sizes Use of CADe is left to the discretion of the treating physician performing the colonoscopy If used CADe will provide real-time feedback throughout each colonoscopy procedure and will alert the endoscopists of the presence of a polyp in the endoscopy field by displaying a bounding box on the same screen
In the control group colonoscopy performed in room without CADe system the participating endoscopists will detect as per standard of care
All colonoscopies in the intervention and control groups including polypectomy procedures will be performed at the discretion of the treating physician and per standard of care
All polyps will be resected and sent to the pathology labs of the participating institutions to be evaluated for histology by board-certified pathologists The histopathology outcomes will be collected and stored in the CRF forms to be used as a reference later
Study Oversight
Has Oversight DMC:
None
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?:
None