MAGENTIQ-COLO for Colonoscopy

Not yet recruiting at 4 trial locations

Overseen By Tal Yerushalmi, MHA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Magentiq Eye LTD

Must not be taking: Anticoagulants

Disqualifiers: Inflammatory bowel disease, Polyposis, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new tool called MAGENTIQ-COLO, which aids doctors during a colonoscopy by better sizing and identifying polyps (small growths in the colon). The goal is to evaluate how effectively this tool finds polyps compared to standard methods. It may suit individuals aged 45 to 80 who are scheduled for a routine colonoscopy and have not been diagnosed with conditions like inflammatory bowel disease or certain polyp syndromes. As an unphased trial, this study allows participants to contribute to innovative research that could enhance colonoscopy procedures for future patients.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, if you are taking anticoagulants (blood thinners), you might need to stop them, as they can affect the procedure.

What prior data suggests that the MAGENTIQ-COLO device is safe for use in colonoscopy?

Research has shown that the MAGENTIQ-COLO device is safe for people. In earlier studies, no major side effects were reported within 30 days of using the device for colonoscopy, indicating that patients handle it well. Additionally, the FDA approved the device in July 2023, confirming it meets safety standards for similar medical devices. Overall, current evidence supports the safety of MAGENTIQ-COLO when used during colonoscopies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about MAGENTIQ-COLO for colonoscopy because it offers a new way to enhance polyp detection during the procedure. Unlike traditional methods that rely solely on the endoscopist's eye, MAGENTIQ-COLO uses real-time technology to assist in identifying colorectal polyps. This could lead to more accurate and thorough screenings, potentially catching polyps that might be missed otherwise. The hope is that this advanced technology will improve early detection rates and ultimately lead to better outcomes for patients undergoing colonoscopy.

What evidence suggests that the MAGENTIQ-COLO is effective for colonoscopy?

Research has shown that MAGENTIQ-COLO can increase the rate of finding adenomas by 7%. Adenomas are growths that might turn into cancer. In this trial, participants will undergo colonoscopy with the real-time use of MAGENTIQ-COLO technology. This AI technology helps doctors find more of these growths during a colonoscopy, reducing the number missed and potentially saving more lives. The system analyzes video from the colonoscope in real-time, making it easier for doctors to spot polyps they might otherwise miss. ^{1 4 6 7 8}

Who Is on the Research Team?

Peter Siersema, MD, Ph.D.

Principal Investigator

Erasmus Medical Center

Are You a Good Fit for This Trial?

This trial is for individuals undergoing a screening colonoscopy. Specific eligibility criteria are not provided, but typically participants would need to be of an age and condition where a colonoscopy is recommended.

Inclusion Criteria

I am between 45 and 80 years old and scheduled for a colonoscopy.

Exclusion Criteria

Pregnancy

Inability to provide informed consent

I have or might have inflammatory bowel disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Colonoscopy Procedure

Participants undergo colonoscopy with the real-time use of the MAGENTIQ-COLO technology to assess colorectal polyps

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the colonoscopy procedure

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• MAGENTIQ-COLO

Trial Overview The study focuses on evaluating the diagnostic performance of MAGENTIQ-COLO, which is a computer-aided detection (CADx) system designed to assist in polyp sizing during colonoscopies.

How Is the Trial Designed?

Group I: Patients will undergo colonoscopy with the real-time use of the MAGENTIQ-COLO technology. Experimental Treatment 1 Intervention

Endoscopists will assess all colorectal polyps detected during colonoscopy with and without the MAGENTIQ-COLO.

Who Is Running the Clinical Trial?

Magentiq Eye LTD

Lead Sponsor

Trials

6

Recruited

3,100+

Citations

1. magentiq.com magentiq.com/lancet-publishes-magentiq-colo-study/

Lancet Publishes Magentiq Colo Study The study shows that using MAGENTIQ-COLO™ increases adenoma detection rate (ADR) by 7% in absolute values.

2. thelancet.com thelancet.com/pdfs/journals/landig/PIIS2589-7500(23)00242-X.pdf

A computer-aided polyp detection system in screening and ... The investigational CAD device, MAGENTIQ-COLO, is based on a computing device that acquires digital video output signals from the colonoscope ...

3. magentiq.com magentiq.com/

MAGENTIQ EYE– AI aided colonoscopy By using such AI products, we found in a recent study that less polyps were missed, the ADR increased, and more lives are potentially saved. Prof.

4. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf24/K244023.pdf

January 24, 2025 Magentiq Eye LTD John J. Smith Partner ... ME-APDSTM (Magentiq Eye's Automatic Polyp Detection System) is intended to be used by endoscopists as an adjunct to the common video colonoscopy ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8704267/

Artificial intelligence-assisted colonoscopy: A review of ... The polyp detection rate and false-positive detection rate were 95% and 60%, respectively. Other significant research used a large dataset for training an AI ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf22/K223473.pdf

Shanil P. Haugen -S - accessdata.fda.gov The ME-APDS (Magentiq Eye's Automatic Polyp Detection System) is intended to be used as an adjunct to the common video colonoscopy procedure.

7. clinicaltrialsarena.com clinicaltrialsarena.com/news/magentiqs-ai-aided-colonoscopy-tool-increases-adenoma-detection-by-7/

Magentiq's AI-aided colonoscopy tool increases adenoma ... Magentiq-Colo device received a 510(k) clearance from the US Food and Drug Administration (FDA) in July 2023. Image Credit: Katy Flaty / ...

8. thelancet.com thelancet.com/journals/landig/article/PIIS2589-7500(23)00242-X/fulltext

A computer-aided polyp detection system in screening and ... Patient records were reviewed for adverse events occurring for up to 30 days after the study procedure. The investigational CAD device, MAGENTIQ-COLO, is based ...