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

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

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Key information

Conditions

Breast Cancer Adenocarcinoma Breast Carcinoma In Situ Breast Diseases Breast Neoplasms Carcinoma Carcinoma in Situ Carcinoma, Intraductal, Noninfiltrating Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Ductal, Lobular, and Medullary Neoplasms, Glandular and Epithelial Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

HaEmek Mc, Afula, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Women diagnosed with carcinoma of the breast
Undergoing lumpectomy (local wide excision) procedure.
Over 18 years of age
Signed ICF

Exclusion criteria

Neoadjuvant systemic therapy
Previous radiation in the operated breast
Prior surgical procedure in the same quadrant
Implants in the operated breast
Pregnancy
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

Dune Device

Device

Sponsors and collaborators

Lead sponsor

Dune Medical Devices

Industry

Registry information

Official study title

MAST Study Protocol

Important dates

Study start: 2006
Primary completion: 2007
Study completion: 2008
First posted: Sep 27, 2006
Registry last updated: May 28, 2008

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