MarginProbe 2.0 Data Collection Protocol

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Hadassah Medical Organization, Jerusalem, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Women over 18 years of age
Diagnosed with cancer, undergoing lumpectomy or partial mastectomy procedure
Signed Informed Consent Form

Exclusion criteria

Undergoing re-excision procedure
Concurrent infectious disease
Pregnancy
Lactation
Previous surgery in the same site including open biopsy procedure, previous breast reduction or mastopexy in the operated breast
Prior radiation treatment in the operated breast
Participating in any other investigational study for either drug or device which can influence collection of valid data under this study

Treatment and study plan

MarginProbe2.0

Device

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.

Other names: MP2.0

Primary outcomes

Adverse Events (AEs) and Serious Adverse Events (SAEs)

Time frame: During the lumpectomy surgery

Adverse Events (AEs) and Serious Adverse Events (SAEs)
Collect MP2.0 data in cohorts of a minimum of 50 subjects to optimize MP2.0 algorithm and procedure.

Time frame: During the lumpectomy surgery

The cohorts will continue to be collected until a final algorithm is established and the cohort(s) can be collected with the final algorithm to determine the sensitivity and specificity to demonstrate non-inferiority to the MP1.x system.

Sponsors and collaborators

Lead sponsor

Dilon Medical Technologies Ltd.

Industry

Registry information

Important dates

Study start: 2021
Primary completion: 2024
Study completion: 2025
First posted: May 17, 2022
Registry last updated: Aug 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed