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

NCT06568523 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: CL-0045
• Study Type: interventional
• Target: 330
• Locations: 3 countries
• Sites: 5

Brief Summary

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

Conditions

Screening Colonoscopy; Surveillance Colonoscopy

Keywords

Colorectal Neoplasms; Intestinal Neoplasms; Digestive System Neoplasms; Screening Colonoscopy; Surveillance Colonoscopy; Automatic Polyp Detection

Outcome Measures

Primary Outcomes (1)

• 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.

  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. The diagnostic performance of the CADx-assisted optical diagnosis to correctly classify colorectal polyps as diminutive (≤5mm) or non-diminutive (\>5mm) compared to size classification using open biopsy forceps, or polypectomy snare, of known diameter. This will be measured by the sensitivity and specificity of the CADx-assisted optical diagnosis compared to an expected minimum of 70% sensitivity and 70% specificity.

  During the Colonoscopy Procedure

Secondary Outcomes (2)

• CADx size measurement vs. open biopsy forceps

  During the Colonoscopy Procedure

• ESGE 'resect-and-discard' & 'leave-in-situ'

  During the Colonoscopy Procedure

Other Outcomes (3)

• ASGE PIVI-1 Post-polypectomy surveillance interval

  During the Colonoscopy Procedure

• ASGE PIVI-2 NPV of neoplastic rectosigmoid polyps

  During the Colonoscopy Procedure

• Rate of high-confidence diagnoses

  During the Colonoscopy Procedure

Study Arms (1)

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

OTHER

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

Diagnostic Test: MAGENTIQ-COLO.

Interventions

MAGENTIQ-COLO. 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.

Also known as: Model: AI-DETECT-GI / AI-DETECT-GI-CU

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

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• In situ polyps with known histology detected in a previous colonoscopy.
• No colorectal polyps detected during colonoscopy.
• Known or suspected inflammatory bowel disease.
• Polyposis syndrome (e.g., familial adenomatous polyposis, serrated polyposis).
• Non-hereditary polyposis syndromes (e.g. Lynch syndrome).
• History of chemotherapy or radiation therapy for colorectal lesions.
• Pregnancy.
• Has a referral for therapeutic procedure (i.e., endoscopic mucosal resection, intervention to stop a lower gastro-intestinal bleeding, etc.).
• Inability to undergo polypectomy (e.g., incorrect continued use of anticoagulants, comorbidities) or patient refusal, as assessed by the endoscopist.
• Inability to provide informed consent.

Sponsors & Collaborators

• Magentiq Eye LTD: lead

Study Sites (5)

Johns Hopkins Hospital

Baltimore, Maryland, 21202, United States

Location

Erlanger Health System

Chattanooga, Tennessee, 37403, United States

Location

Assuta

Haifa, Select State, Israel

Location

Hadassah Medical Organization

Jerusalem, 91120, Israel

Location

Erasmus Medical Center

Rotterdam, 3000 CA, Netherlands

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Intestinal Neoplasms; Digestive System Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Peter Siersema, MD, Ph.D.

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dror Zur, Ph.D

CONTACT

+972 547 555922; dror@magentiq.com

Tal Yerushalmi, MHA

CONTACT

+972 50 2936610; tal@myclinical.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2024
• First Posted: August 23, 2024
• Study Start: September 15, 2024
• Primary Completion: August 31, 2025
• Study Completion: August 31, 2025
• Last Updated: August 23, 2024

Record last verified: 2024-08

Locations

US (2); IL (2); NL (1)