Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06621225
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-09-07
Brief Title:
Artificial Intelligence in Colonoscopy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Randomized Trial on the Utilization of Endocuff-assisted Colonoscopy and Computer-aided Detection in Optimizing Colonoscopies in the Elderly
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AIColonoscopy
Brief Summary:
N 264 patients 50 female aged 75 years and above undergoing colonoscopy were enrolled Patients were randomly assigned into one of the three intervention groups the primary intervention arm CADe in combination with the MED the second group with MED alone and the control group with WLE All detected lesions were removed and sent to histopathology for diagnosis The primary outcome was the adenoma detection rate Secondary outcomes were adenoma detection in the left colon in our cohort of patients
Detailed Description:
264 patients with an equal gender distribution 50 female aged 75 years and above undergoing screening and diagnostic colonoscopy at The Surgery and Endoscopy Center of Sebring Sebring Florida were enrolled in this study The eligibility criteria for a randomized controlled trial RCT comparing AI and mucosal exposure devices together mucosal exposure devices alone and white light endoscopy in patients 75 years and older could be structured as follows
Patients were randomly allocated into one of three study groups the primary intervention arm where colonoscopy was performed using the CADe in combination with the MED the second group underwent colonoscopy solely with the MED while the control group underwent colonoscopy solely with the WLE We used a Convolutional Neural Network-based CADe system GI Genius acquired for licensed use from Medtronic Inc Minneapolis MN The MED employed was the EndoCuff Vision ECV developed by Olympus America Center Valley PA which constitutes part of the standard equipment available All detected lesions were identified and excised throughout the colonoscopy procedures and specimens were promptly sent for histopathological analysis
The primary outcome of interest was adenoma detection rate ADR defined as the percentage of patients in whom at least one histologically proven adenoma or carcinoma was identified during colonoscopy Secondary outcomes included ADR in the left colon in our cohort of patients
This study was conducted according to accepted ethical principles and approved by the institutional review board IRB of The Surgery and Endoscopy Center of Sebringamp34 Informed consent was obtained from all participants before enrollment and measures were taken to ensure patient confidentiality and data protection throughout the study period
Patients were randomly allocated into one of three study groups the primary intervention arm where colonoscopy was performed using the CADe in combination with the MED the second group underwent colonoscopy solely with the MED while the control group underwent colonoscopy solely with the WLE We used a Convolutional Neural Network-based CADe system GI Genius acquired for licensed use from Medtronic Inc Minneapolis MN The MED employed was the EndoCuff Vision ECV developed by Olympus America Center Valley PA which constitutes part of the standard equipment available All detected lesions were identified and excised throughout the colonoscopy procedures and specimens were promptly sent for histopathological analysis
The primary outcome of interest was adenoma detection rate ADR defined as the percentage of patients in whom at least one histologically proven adenoma or carcinoma was identified during colonoscopy Secondary outcomes included ADR in the left colon in our cohort of patients
This study was conducted according to accepted ethical principles and approved by the institutional review board IRB of The Surgery and Endoscopy Center of Sebringamp34 Informed consent was obtained from all participants before enrollment and measures were taken to ensure patient confidentiality and data protection throughout the study period
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None