Screening ColonoscopyNCT04640792
A Study to Evaluate the Safety and Efficacy of the Use of ME-APDS During Colonoscopy
A study testing Screening or Surveillance Conventionall colonoscopy in people with Screening Colonoscopy and Surveillance Colonoscopy, run by Magentiq Eye LTD at 11 sites in 4 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Screening Colonoscopy, Surveillance Colonoscopy
- What is being tested?
- Screening or Surveillance Conventionall colonoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 952 participants
- Where
- 11 sitesin 4 countries
- Study dates
- 1 Oct 2020to 10 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Able to provide written informed consent prior to any study procedures;
- Able to communicate clearly with the Investigators and study staff;
- Males and females aged between 18 - 90 years of age;
- Referred and scheduled for either screening colonoscopy or surveillance colonoscopy if the last colonoscopy was performed 3 years or more before the scheduled colonoscopy;
- Has not been referred to the test after positive iFOBT.
Who cannot join
- Has a known or suspected colorectal tumor or polyp on referral;
- Has a referral for therapeutic procedure (i.e. endoscopic mucosal resection, intervention to stop a lower gastro-intestinal bleeding, etc.);
- Has not corrected anticoagulation disorders;
- Inability to provide informed consent;
- Has any clinically significant condition that would, in the opinion of the investigator, preclude study participation;
- Unable or unwilling, in the opinion of the Investigator to comply with the requirements of the protocol;
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- Employees of the investigator and study site or the sponsor, as well as family members of the employees or the investigator or the sponsor;
- Has inadequate bowel preparation, defined as: Boston Bowel Preparation Score (BBPS) <6 or any segment <2 (each procedure report will include the BBPS);
- Any woman who is pregnant or potentially pregnant.
Trial locations and contacts
11 sites in 4 countries.
11 sites in 4 countries
United States4 sites
Johns Hopkins Hospital
Baltimore, Maryland, 21202
Erlanger Health System
Chattanooga, Tennessee, 37403
MetroHealth System
Cleveland, Ohio, 44109
Columbia University Irving Medical Center
New York, New York, 10032
Israel4 sites
Department of Gastroenterology, Shamir Medical Center, Israel
Be’er Ya‘aqov
Shamir Medical Center
Be’er Ya‘aqov
Assuta
Haifa, Select State
Hadassah Medical Organization
Jerusalem, 91120
Germany2 sites
GastroZentrum Lippe
Bad Salzuflen, 32105
Mainz University Medical Center
Mainz
About this study
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
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.
Read the 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.
- Conditions
- Screening Colonoscopy, Surveillance Colonoscopy
- Being tested
- Screening or Surveillance Conventionall 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
- Medical subject headings
- Colorectal Neoplasms, Intestinal Neoplasms, Gastrointestinal Neoplasms, Digestive System Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Screening or Surveillance Conventionall colonoscopyProcedure or surgery
Patients in Group A (CC) will undergo Screening or Surveillance Conventual Colonoscopy, Patients in Group B (MEAC) will undergo Screening or Surveillance Colonoscopy with ME-ADPS Device
| Study group | Role | What they receive |
|---|---|---|
| Common Colonoscopy (Group A) | No intervention | Patients will be examined with Conventional Colonoscopy (CC) |
| Magentiq Eye Assisted Colonoscopy (Group B) | Experimental | Patients will be examined with Magentiq Eye Assisted Colonoscopy (MEAC) Receives: Procedure: Screening or Surveillance Conventionall colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the Adenoma Per Colonoscopy (APC) between the two arms
Compare the APC of the Magentiq Eye Assisted Colonoscopy (MEAC) with the Conventional Colonoscopy (CC)
Measured: During the Colonoscopy Procedure
Comparison of the Adenoma Per Extraction (APE) between the two arms
Compare the APE of the MEAC with the CC
Measured: During the Colonoscopy Procedure
Secondary outcomes (2)
Comparison of the Adenoma Miss Rate (AMR) between the two arms
Compare the AMR of the MEAC with the CC
Measured: During the Colonoscopy Procedure
Comparison of the Adenoma Detection Rate (ADR) between the two arms
Compare the ADR of the MEAC with the CC
Measured: During the Colonoscopy Procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2020
- Study start1 Oct 2020
- Primary completion10 Feb 2022
- Study completion10 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Screening ColonoscopyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 952 participants (actual)
Sponsor and investigators
- Lead sponsor
- Magentiq Eye LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peter Siersema, MD, Ph.D., Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04640792
- Sponsor's protocol ID
- CL-0001
- Status last verified
- Mar 2022
- First submitted
- 13 Nov 2020
- Last updated
- 5 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Maas MHJ, Neumann H, Shirin H, Katz LH, Benson AA, Kahloon A, Soons E, Hazzan R, Landsman MJ, Lebwohl B, Lewis SK, Sivanathan V, Ngamruengphong S, Jacob H, Siersema PD. A computer-aided polyp detection system in screening and surveillance colonoscopy: an international, multicentre, randomised, tandem trial. Lancet Digit Health. 2024 Mar;6(3):e157-e165. doi: 10.1016/S2589-7500(23)00242-X.
PubMed 38395537
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04640792
- Acronym / sponsor ID
- CL-0001
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 952 participants (actual)
- Lead sponsor
- Magentiq Eye LTDIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 10 Feb 2022 (actual)
- Study completion
- 10 Feb 2022 (actual)
- First posted
- 23 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Common Colonoscopy (Group A) | No intervention | –Patients will be examined with Conventional Colonoscopy (CC) |
| Magentiq Eye Assisted Colonoscopy (Group B) | Experimental | Procedure: Screening or Surveillance Conventionall colonoscopyPatients will be examined with Magentiq Eye Assisted Colonoscopy (MEAC) |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Able to provide written informed consent prior to any study procedures;
- Able to communicate clearly with the Investigators and study staff;
- Males and females aged between 18 - 90 years of age;
- Referred and scheduled for either screening colonoscopy or surveillance colonoscopy if the last colonoscopy was performed 3 years or more before the scheduled colonoscopy;
- Has not been referred to the test after positive iFOBT.
Key exclusion criteria (9 listed)
- Has a known or suspected colorectal tumor or polyp on referral;
- Has a referral for therapeutic procedure (i.e. endoscopic mucosal resection, intervention to stop a lower gastro-intestinal bleeding, etc.);
- Has not corrected anticoagulation disorders;
- Inability to provide informed consent;
- Has any clinically significant condition that would, in the opinion of the investigator, preclude study participation;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Screening or Surveillance Conventionall colonoscopyPatients in Group A (CC) will undergo Screening or Surveillance Conventual Colonoscopy, Patients in Group B (MEAC) will undergo Screening or Surveillance Colonoscopy with ME-ADPS Device | Procedure or surgery | Magentiq Eye Assisted Colonoscopy (Group B) |
Primary outcome
Comparison of the Adenoma Per Colonoscopy (APC) between the two arms
Time frame: During the Colonoscopy Procedure
Compare the APC of the Magentiq Eye Assisted Colonoscopy (MEAC) with the Conventional Colonoscopy (CC)
Comparison of the Adenoma Per Extraction (APE) between the two arms
Time frame: During the Colonoscopy Procedure
Compare the APE of the MEAC with the CC
2 secondary outcomes
Comparison of the Adenoma Miss Rate (AMR) between the two arms
Time frame: During the Colonoscopy Procedure
Comparison of the Adenoma Detection Rate (ADR) between the two arms
Time frame: During the Colonoscopy Procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2022.
- Derived from this study: PubMed 38395537Maas MHJ, Neumann H, Shirin H, Katz LH, Benson AA, Kahloon A, Soons E, Hazzan R, Landsman MJ, Lebwohl B, Lewis SK, Sivanathan V, Ngamruengphong S, Jacob H, Siersema PD. A computer-aided polyp detection system in screening and surveillance colonoscopy: an international, multicentre, randomised, tandem trial. Lancet Digit Health. 2024 Mar;6(3):e157-e165. doi: 10.1016/S2589-7500(23)00242-X.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Siersema, MD, Ph.D. principal investigator
Radboud University Medical Center
11 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Screening or Surveillance Conventionall colonoscopy in people with Screening Colonoscopy and Surveillance Colonoscopy, run by Magentiq Eye LTD at 11 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States, Israel, Germany, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of the Adenoma Per Colonoscopy (APC) between the two arms (time frame: During the Colonoscopy Procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04640792, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2022.