MedTrace Logo

MarginProbe® System U.S. Post-Approval Study

NCT02406599 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 440

Last updated 2021-08-18

No results posted yet for this study

Summary

The study objective is to determine the MarginProbe® System's diagnostic accuracy at the margin level and impact on Positive Margin\* Presence originating from the Main ex-vivo lumpectomy specimen after the initial lumpectomy surgery.

\*A positive margin is defined in this study as a margin microscopically measured and reported in the histology report to have cancer within 1 mm or less of the inked surface

Conditions

Interventions

DEVICE

Margin Probe

The surgeon will use the MarginProbe System to identify cancerous tissue at the margins (≤ 1mm) of the main ex-vivo lumpectomy specimen following primary excision

OTHER

Control: Additional inspection

The surgeon will perform additional inspection and assessment of the margins of the main ex-vivo lumpectomy specimen following primary excision

Sponsors & Collaborators

  • Dune Medical Devices

    lead INDUSTRY

Principal Investigators

  • Maya Livnat · Dilon Medical Technologies Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2021-09-30
Completion
2021-11-30

Countries

  • United States

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 NCT02406599 on ClinicalTrials.gov