Ignite Creation Date:
2024-05-06 @ 3:29 PM
Last Modification Date:
2024-10-26 @ 1:50 PM
Study NCT ID:
NCT04640792
Status:
COMPLETED
Last Update Posted:
2022-05-05
First Post:
2020-11-13
Brief Title:
A Study to Evaluate the Safety and Efficacy of the Use of ME-APDS During Colonoscopy
Sponsor:
Magentiq Eye LTD
Organization:
Magentiq Eye LTD
Study Overview
Official Title:
A Randomized Two Arm Multi-Center Study to Evaluate the Safety and Efficacy of the Use of Magentiq Eyes Automatic Polyp Detection System ME-APDS During Colonoscopy
Status:
COMPLETED
Status Verified Date:
2022-03
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:
ME-APDS is a device software-based with hardware developed by Magentiq Eye LTD and intended to support the decision of the endoscopist on polyps which appear in the colonoscopy video during the colonoscopy procedure
This randomized two arm colonoscopy trial will mainly compare APC and APE between Magentiq Eye Assisted Colonoscopy MEAC and Conventional Colonoscopy CC in patients referred for either screening or surveillance colonoscopies
This randomized two arm colonoscopy trial will mainly compare APC and APE between Magentiq Eye Assisted Colonoscopy MEAC and Conventional Colonoscopy CC in patients referred for either screening or surveillance colonoscopies
Detailed Description:
The primary objective of the present study is to compare the number of Adenomas Per Colonoscopy APC and the Adenomas Per Extraction APE between the Magentiq Eye-Assisted Colonoscopy MEAC and Conventional Colonoscopy CC These are also the co-primary endpoints
The secondary endpoints are Adenoma Miss Rate AMR tested on part of the total study population and Adenoma Detection Rate ADR
This study mainly hypothesizes that more adenomas will be detected in MEAC compared to CC higher APC in MEAC compared to CC and that the reduction of APE in MEAC compared to CC if there will be a reduction will be limited
The study also assumes that AMR will be reduced in MEAC compared to CC and that ADR will increase to some level in MEAC compared to CC
The study will include 952 subjects Eligible patients will be randomized in a 11 ratio into two groups group A and B In group A patients will be examined with CC Patients in group B will be examined using MEAC Immediately after the randomization a sub-randomization will be performed on whether an immediate second examination for AMR calculation will be conducted or not 136 patients will undergo second examination
The colonoscopy will be performed in accordance with the standard of care of each medical center in either MEAC or CC
After the colonoscopy procedure patients will be observed at the endoscopy unit until the discharge criteria are met as per the standard clinical protocol of the medical center After here they will be discharged by the treating physician
Study follow-up period will be up to 30-days post-colonoscopy to register serious adverse events and it will be in accordance with the standard of care of medical center
The secondary endpoints are Adenoma Miss Rate AMR tested on part of the total study population and Adenoma Detection Rate ADR
This study mainly hypothesizes that more adenomas will be detected in MEAC compared to CC higher APC in MEAC compared to CC and that the reduction of APE in MEAC compared to CC if there will be a reduction will be limited
The study also assumes that AMR will be reduced in MEAC compared to CC and that ADR will increase to some level in MEAC compared to CC
The study will include 952 subjects Eligible patients will be randomized in a 11 ratio into two groups group A and B In group A patients will be examined with CC Patients in group B will be examined using MEAC Immediately after the randomization a sub-randomization will be performed on whether an immediate second examination for AMR calculation will be conducted or not 136 patients will undergo second examination
The colonoscopy will be performed in accordance with the standard of care of each medical center in either MEAC or CC
After the colonoscopy procedure patients will be observed at the endoscopy unit until the discharge criteria are met as per the standard clinical protocol of the medical center After here they will be discharged by the treating physician
Study follow-up period will be up to 30-days post-colonoscopy to register serious adverse events and it will be in accordance with the standard of care of medical center
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?:
False
Is an FDA AA801 Violation?:
None