Ignite Creation Date:
2025-12-24 @ 3:51 PM
Ignite Modification Date:
2026-01-03 @ 9:28 PM
Study NCT ID:
NCT04640792
Status:
COMPLETED
Last Update Posted:
2022-05-05
First Post:
2020-11-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Safety and Efficacy of the Use of ME-APDS During Colonoscopy
Sponsor:
Magentiq Eye LTD
Organization:
Study Overview
Official Title:
A Randomized Two Arm Multi-Center Study to Evaluate the Safety and Efficacy of the Use of Magentiq Eye's 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 1:1 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 1:1 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:
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?:
False
Is an FDA AA801 Violation?: