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NCT00380952 Clinical Trial

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

Breast Cancer Clinical Trial

Official title:
MAST Study Protocol

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00380952
Other study ID # CP-02-001
Secondary ID
Status Completed
Phase N/A
First received September 26, 2006
Last updated May 25, 2008
Start date November 2006
Est. completion date April 2008

Study information
Verified date May 2008
Source Dune Medical Devices
Contact n/a
Is FDA regulated No
Health authority Israel: Israeli Health Ministry Pharmaceutical Administration
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 300
Est. completion date April 2008
Est. primary completion date October 2007
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• Dune Device

Locations
Country Name City State
Israel HaEmek Mc Afula
Israel Rambam MC Haifa
Israel Haddasah Medical Organization Jerusalem
Israel Shaare Zedek Jerusalem
Israel Meir MC Kfar Saba
Israel Rabin MC Petah Tikva
Israel Souraski MC Tel- Aviv
Israel Poria MC Tiberia
Israel Rivka Ziv MC Zefat

Sponsors (1)
Lead Sponsor Collaborator
Dune Medical Devices

Country where clinical trial is conducted

Israel, 

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