Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04640792 |
Other study ID # |
CL-0001 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
October 1, 2020 |
Est. completion date |
February 10, 2022 |
Study information
Verified date |
March 2022 |
Source |
Magentiq Eye LTD |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
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.