Intraoperative Use of the BP Device for Detecting Positive Margins During Lumpectomy Procedure

Dune Medical Devices300 enrolled

Overview

This protocol was designed for testing the intraoperative use of the Dune device. This multicenter study will take place in Israel at 12 sites.

Use of the device will take place during a partial mastectomy procedure (lumpectomy).The patient will be randomized to enter the device or control arm.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

300

Conditions

Breast Cancer

Interventions

Dune DeviceDEVICE

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion criteria 1. Women diagnosed with carcinoma of the breast 2. Undergoing lumpectomy (local wide excision) procedure. 3. Over 18 years of age 4. Signed ICF Exclusion criteria 1. Neoadjuvant systemic therapy 2. Previous radiation in the operated breast 3. Prior surgical procedure in the same quadrant 4. Implants in the operated breast 5. Pregnancy 6. Participating in any other investigational study for either drug or device which can influence collection of valid data under this study.

Locations (9)

HaEmek Mc

Afula, Israel

Rambam MC

Haifa, Israel

Haddasah Medical Organization

Jerusalem, Israel

Shaare Zedek

Jerusalem, Israel

Data from ClinicalTrials.gov

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