• Evaluate the safety of ME-APDS in subjects during colonoscopy.• Assess the efficacy of ME-APDS - whether the use of the ME-APDS improves the Adenoma Per Colonoscopy APC when compared to conventional colonoscopy (CC). Thereby we aim to further…
ID
Source
Brief title
Condition
- Benign neoplasms gastrointestinal
- Gastrointestinal neoplasms benign
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Safety Endpoints
• Incidence of Serious AEs (SAEs)
Efficacy Endpoints
Co-Primary
• Adenoma Per Colonoscopy (APC): between the Magentiq Eye-assisted colonoscopy
and conventional colonoscopy, calculated only on the first examination.
• Adenoma Per Extraction (APE): between the Magentiq Eye-assisted colonoscopy
and conventional colonoscopy, calculated only on the first examination.
Secondary outcome
• The Adenoma Miss Rate (AMR), calculated as the number of ade-nomas detected
in the second examination divided by the total number of adenomas detected in
the both examinations, between Magentiq Eye-assisted colonoscopy as first
examination (AMR of MAEC) and conventional colonoscopy as first examination
(AMR of CC).
• Adenoma Detection Rate (ADR), calculated as the number of pa-tients who have
one or more adenomas detected and removed di-vided by the total number of
patients, between the Magentiq Eye-assisted colonoscopy and conventional
colonoscopy, calculated only on the first examination.
Background summary
Recently, we have developed the Magentiq Eye*s Automatic Polyp Detection System
(ME-ADPS). Pre-clinical studies show an 89% sensitivity and a 98.4%
specificity, and the last offline test with the system showed that 97.3% of the
polyps were detected (where at least one frame of the polyp shall be detected
in order to define the polyp as detected) with system precision of 96%.
Study objective
• Evaluate the safety of ME-APDS in subjects during colonoscopy.
• Assess the efficacy of ME-APDS - whether the use of the ME-APDS improves the
Adenoma Per Colonoscopy APC when compared to conventional colonoscopy (CC).
Thereby we aim to further improve the care that is provided to patients at risk
of developing CRC.
• Compare the Adenoma Per Extraction (APE) of the ME-APDS group with the CC
group.
Secondary objectives of this study are
• Compare the Adenoma Miss Rate (AMR) of the ME-APDS group with the CC group.
• Compare the Adenoma Detection Rate (ADR) of the ME-APDS group with the CC
group.
Study design
Randomized, two arm colonoscopy trial, including 952 patients. Participants
will be randomized twice
1. Randomization to undergo ME-APDS assisted colonoscopy or conventional
colonoscopy
2. Randomization to undergo a second colonoscopy examination
The aim of the second randomization is to have a small group of patients (136)
that undergo both colonoscopy procedures, to compare the adenoma miss rate
(AMR).
Intervention
Colonoscopy
Study burden and risks
Patients will be enrolled for a period starting up to 30 days prior to
procedure date and ending after 30 days of follow up from procedure date. The
risks of adverse events for Magentiq Eye assisted colonoscopy are believed to
be equivalent to conventional colonoscopy, except of that the rise in APC might
also lead to longer procedure times and more adverse events such as delayed
bleeding, caused by an increased number of polypectomies. Apart from the
randomization patients will be treated as per protocol. Probably more polyps
will be detected during Magentiq Eye assisted colonoscopy, depending on the
type of polyp this might have a beneficial effect on the morbidity and
mortality resulting from colorectal carcinoma.
7FL, City Center Tower, Ben-Gurion Blvd, 6
Haifa 3541416
IL
7FL, City Center Tower, Ben-Gurion Blvd, 6
Haifa 3541416
IL
Listed location countries
Age
Inclusion criteria
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.
Exclusion criteria
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.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL77061.091.21 |