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

Dune Medical Devices

Status: Completed

Conditions: Breast Cancer

Treatments: Device: Dune Device

Study type: Interventional

Funder types: Industry

Identifiers

NCT00380952

CP-02-001

Details and patient eligibility

About

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

Full description

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.

Enrollment: 300 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind