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MarginProbe 2.0 Data Collection Protocol

NCT05377229 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 398

Last updated 2025-08-28

No results posted yet for this study

Summary

Previous clinical studies with the MarginProbe (MP) system demonstrated the MP System diagnostic accuracy for identification of cancerous/abnormal tissue at the margins (≤ 1mm) of the ex-vivo lumpectomy specimen. The current study is a prospective data collection study with the enhanced technology, the MP2.0 System and is aimed at collecting data to optimize the system algorithm/procedure and to subsequently validate the system to demonstrate non-inferiority to the MP1.x system.

In this study, MP2.0 system will be used on ex-vivo lumpectomy specimens at the Operating Room (OR). The study will collect a library of case information data using the MP2.0 system in sequential cohorts of a minimum of 50 subjects until the software and procedure are optimized. The final analysis sample size will be determined and outlined in the SAP based upon the results of the optimization stage.

Conditions

Interventions

DEVICE

MarginProbe2.0

The MarginProbe System is an adjunctive diagnostic tool for identification of cancerous tissue at the margins of the ex-vivo lumpectomy specimen following primary excision and is indicated for intraoperative use, in conjunction with standard methods (such as intraoperative imaging and palpation) in patients undergoing breast lumpectomy surgery for previously diagnosed breast cancer.

Sponsors & Collaborators

  • Dilon Medical Technologies Ltd.

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-15
Primary Completion
2024-08-23
Completion
2025-01-12
FDA Device
Yes

Countries

  • United States
  • Israel

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05377229 on ClinicalTrials.gov