Study to Evaluate the Diagnostic Performance of of MAGENTIQ-COLO During Colonoscopy.

NCT ID: NCT06568523

Last Updated: 2024-08-23

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 330 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-15
• Study Completion Date: 2025-08-31

Brief Summary

This is an international, multicenter, study to evaluate the diagnostic performance of the CADx polyp sizing modality of the MAGENTIQ-COLO.

Detailed Description

Colonoscopy is the gold standard for the detection and removal of premalignant colorectal polyps. Recommended post-polypectomy surveillance intervals are primarily based on pathological diagnosis and polyp size. However, accurate estimation of polyp size remains challenging, potentially influencing post-polypectomy surveillance intervals. Inaccuracies in size estimation may lead to either unnecessary or prematurely scheduled surveillance colonoscopies when overestimating size or lead to an increased risk of post-colonoscopy colorectal cancer or advanced neoplasia when underestimating size. Furthermore, diminutive (1-5mm) polyps pose challenges due to their high incidence and frequent pathological assessment. Proposed strategies to reduce this burden, such as the European Society of Gastrointestinal Endoscopy (ESGE) 'resect-and-discard' strategy, are infrequently used as non-expert endoscopists often do not meet diagnostic thresholds when using standard visual inspection. The MAGENTIQ-COLO computer-aided diagnosis (CADx) system by Magentiq Eye LTD, Haifa, Israel, addresses these challenges by providing real-time polyp size estimation and polyp characterization. Additionally, this study evaluates the diagnostic accuracy of the MAGENTIQ-COLO CADx system in an average-risk screening and surveillance colonoscopy population.

The primary objective of the study is to assess the diagnostic performance of the endoscopist performing a MAGENTIQ-COLO CADx-assisted colonoscopy to classify polyps as diminutive (≤5mm) or non-diminutive (>5mm) compared to the size classification using open biopsy forceps, or polypectomy snares, of known diameter.

This will be measured by comparing the sensitivity and specificity between the two size classifications. Secondary objective include:

• To assess the diagnostic performance of the endoscopist performing a MAGENTIQ-COLO CADx-assisted colonoscopy to diagnose diminutive (rectosigmoid) colorectal polyps as neoplastic (adenoma or sessile serrated lesion (SSL)) with high-confidence compared to the pathology diagnosis. This will be measured by the sensitivity and specificity between the two diagnoses;
• To assess the diagnostic performance of the CADx system in measuring the size in millimeters and the size classification of colorectal polyps compared to the size measurement using open biopsy forceps, or polypectomy snare, of known diameter; this correlation will also be conducted for classifying polyps into diminutive (≤5mm), small (6-9mm), and advanced (≥10mm) size categories.

The sensitivity of the CADx-assisted optical diagnosis in classifying colorectal polyps as diminutive (≤5mm) or non-diminutive (>5mm) compared to the reference gold standard, which is the size classification of the colorectal polyp using open biopsy forceps, or polypectomy snare, of known diameter.

This is an international, multicenter, study to evaluate the diagnostic performance of the CADx polyp sizing modality of the MAGENTIQ-COLO. Study subjects who are already referred for screening or surveillance colonoscopy, will undergo colonoscopy with the real-time use of the MAGENTIQ-COLO technology. Endoscopists will assess all colorectal polyps detected during colonoscopy with and without the MAGENTIQ-COLO. Diagnostic performance of polyp size classification and optical diagnosis with and without MAGENTIQ-COLO is evaluated with reference to open biopsy forceps, or polypectomy snare of known diameter size classification, and pathology-based diagnosis, respectively. There is no formal study subject follow-up. Study procedures will be performed intraprocedural during the colonoscopy. Final pathological diagnosis will be recorded from the electronic health record.

The unit of analysis is the colorectal polyp rather than a study subject. The study is planned to include 396 colorectal polyps. Based on an expected detection rate of approximately 1.20 polyps per colonoscopy in the study population, we assume that enrollment of 330 subjects will be sufficient to meet the study objectives.

Conditions

Screening Colonoscopy; Surveillance Colonoscopy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Patients will undergo colonoscopy with the real-time use of the MAGENTIQ-COLO technology.

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

Group Type: OTHER

MAGENTIQ-COLO.

Intervention Type: DIAGNOSTIC_TEST

This is a diagnostic performance study; no randomization will be conducted. All subjects will undergo the same study procedures. The endoscopist performing the examinations cannot be blinded for the output of the investigational device in this study. Due to the nature of the intervention, it is not guaranteed that the patient is not awake during the procedure, therefore blinding for the patient is also not feasible.

Interventions

MAGENTIQ-COLO.

This is a diagnostic performance study; no randomization will be conducted. All subjects will undergo the same study procedures. The endoscopist performing the examinations cannot be blinded for the output of the investigational device in this study. Due to the nature of the intervention, it is not guaranteed that the patient is not awake during the procedure, therefore blinding for the patient is also not feasible.

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

Model: AI-DETECT-GI / AI-DETECT-GI-CU

Eligibility Criteria

Inclusion Criteria

• Individuals aged ≥45 - ≤80 years old, who are scheduled for non-iFOBT screening or surveillance colonoscopy.

Exclusion Criteria

1. In situ polyps with known histology detected in a previous colonoscopy.

2. No colorectal polyps detected during colonoscopy.

3. Known or suspected inflammatory bowel disease.

4. Polyposis syndrome (e.g., familial adenomatous polyposis, serrated polyposis).

5. Non-hereditary polyposis syndromes (e.g. Lynch syndrome).

6. History of chemotherapy or radiation therapy for colorectal lesions.

7. Pregnancy.

8. Has a referral for therapeutic procedure (i.e., endoscopic mucosal resection, intervention to stop a lower gastro-intestinal bleeding, etc.).

9. Inability to undergo polypectomy (e.g., incorrect continued use of anticoagulants, comorbidities) or patient refusal, as assessed by the endoscopist.

10. Inability to provide informed consent.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Magentiq Eye LTD

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peter Siersema, MD, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Erasmus Medical Center

Locations

Johns Hopkins Hospital

Baltimore, Maryland, United States

Erlanger Health System

Chattanooga, Tennessee, United States

Assuta

Haifa, Select State, Israel

Hadassah Medical Organization

Jerusalem, , Israel

Erasmus Medical Center

Rotterdam, , Netherlands

Countries

United States; Israel; Netherlands

Central Contacts

Dror Zur, Ph.D

Role: CONTACT

dror@magentiq.com

+972 547 555922

Tal Yerushalmi, MHA

Role: CONTACT

tal@myclinical.net

+972 50 2936610

Other Identifiers

CL-0045

Identifier Type: -

Identifier Source: org_study_id