Clinical trial NCT04640792: A Study to Evaluate the Safety and Efficacy of the Use of ME-APDS During Colonoscopy
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Screening Colonoscopy
Surveillance Colonoscopy
Keywords: Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Screening Colonoscopy
Surveillance Colonoscopy
Automatic Polyp Detection
Adenoma Per Colonoscopy
Adenoma Per Extraction
Adenoma Miss Rate
Adenoma Detection Rate
Lead sponsor: Magentiq Eye LTD
Sponsor class: INDUSTRY
First posted: 2020-11-23
Enrollment: 952
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.

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.

Eligibility criteria: 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 colonoscopy or surveillance colonoscopy if the last colonoscopy was performed 3 years or more before the scheduled colonoscopy;
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, preclude 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.

Primary outcomes:
measure: Comparison of the Adenoma Per Colonoscopy (APC) between the two arms
timeFrame: During the Colonoscopy Procedure
measure: Comparison of the Adenoma Per Extraction (APE) between the two arms
timeFrame: During the Colonoscopy Procedure
Secondary outcomes:
measure: Comparison of the Adenoma Miss Rate (AMR) between the two arms
timeFrame: During the Colonoscopy Procedure
measure: Comparison of the Adenoma Detection Rate (ADR) between the two arms
timeFrame: During the Colonoscopy Procedure
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
city: New York
country: United States
facility: Columbia University Irving Medical Center
state: New York
city: Cleveland
country: United States
facility: MetroHealth System
state: Ohio
city: Chattanooga
country: United States
facility: Erlanger Health System
state: Tennessee
city: Bad Salzuflen
country: Germany
facility: GastroZentrum Lippe
city: Mainz
country: Germany
facility: Mainz University Medical Center
city: Haifa
country: Israel
facility: Assuta
state: Select State
city: Be'er Ya'aqov
country: Israel
facility: Department of Gastroenterology, Shamir Medical Center, Israel
city: Be'er Ya'aqov
country: Israel
facility: Shamir Medical Center
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
city: Nijmegen
country: Netherlands
facility: The Radboud University Medical Center
Study officials:
affiliation: Radboud University Medical Center
name: Peter Siersema, MD, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: