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
- Conditions
- Colorectal adenomas and polyps1001798710017934
- Registration Number
- NL-OMON50965
- Lead Sponsor
- Magentiq Eye LTD
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 100
1. Able to provide written informed consent prior to any study procedures;
2. Able to communicate clearly with the Investigators and study staff;
3. Males and females aged between 18 * 90 years of age;
4. Referred and Scheduled for either screening or surveillance colonoscopy
which is sched-uled every 3 to 10 years;
5. Has not been referred to the test after positive iFOBT.
1. Has a known or suspected colorectal tumor or polyp on referral;
2. Has a referral for therapeutic procedure (i.e. endoscopic mucosal resection,
intervention to stop a lower gastro-intestinal bleeding, etc.);
3. Has not corrected anticoagulation disorders;
4. Inability to provide informed consent;
5. Has any clinically significant condition that would, in the opinion of the
investigator, pre-clude study participation;
6. Unable or unwilling, in the opinion of the Investigator to comply with the
requirements of the protocol;
7. Employees of the investigator and study site or the sponsor, as well as
family members of the employees or the investigator or the sponsor;
8. Has inadequate bowel preparation, defined as: Boston Bowel Preparation Score
(BBPS) <6 or any segment <2 (each procedure report will include the BBPS);
9. Any woman who is pregnant or potentially pregnant.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Safety Endpoints<br /><br>* Incidence of Serious AEs (SAEs)<br /><br><br /><br>Efficacy Endpoints<br /><br>Co-Primary<br /><br>* Adenoma Per Colonoscopy (APC): between the Magentiq Eye-assisted colonoscopy<br /><br>and conventional colonoscopy, calculated only on the first examination.<br /><br>* Adenoma Per Extraction (APE): between the Magentiq Eye-assisted colonoscopy<br /><br>and conventional colonoscopy, calculated only on the first examination. </p><br>
- Secondary Outcome Measures
Name Time Method <p>* The Adenoma Miss Rate (AMR), calculated as the number of ade-nomas detected<br />in the second examination divided by the total number of adenomas detected in<br />the both examinations, between Magentiq Eye-assisted colonoscopy as first<br />examination (AMR of MAEC) and conventional colonoscopy as first examination<br />(AMR of CC).<br />* Adenoma Detection Rate (ADR), calculated as the number of pa-tients who have<br />one or more adenomas detected and removed di-vided by the total number of<br />patients, between the Magentiq Eye-assisted colonoscopy and conventional<br />colonoscopy, calculated only on the first examination. </p>