Status:
COMPLETED
Intraoperative Use of the BP Device for Detecting Positive Margins During Lumpectomy Procedure
Lead Sponsor:
Dune Medical Devices
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief 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.
Detailed 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.
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2008
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT00380952
Start Date
November 1 2006
End Date
April 1 2008
Last Update
May 28 2008
Active Locations (9)
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1
HaEmek Mc
Afula, Israel
2
Rambam MC
Haifa, Israel
3
Haddasah Medical Organization
Jerusalem, Israel
4
Shaare Zedek
Jerusalem, Israel