Intraoperative Use of the BP Device for Detecting Positive Margins During Lumpectomy Procedure
NCT ID: NCT00380952
Last Updated: 2008-05-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
300 participants
INTERVENTIONAL
2006-11-30
2008-04-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Interventions
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Dune Device
Eligibility Criteria
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Inclusion Criteria
2. Undergoing lumpectomy (local wide excision) procedure.
3. Over 18 years of age
4. Signed ICF
Exclusion Criteria
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.
18 Years
FEMALE
No
Sponsors
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Dune Medical Devices
INDUSTRY
Responsible Party
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Medical VP
Principal Investigators
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Dan Hershko, Dr.
Role: PRINCIPAL_INVESTIGATOR
Rambam MC
Rona Spector, Dr.
Role: PRINCIPAL_INVESTIGATOR
Rabin MC
Eran Sharon
Role: PRINCIPAL_INVESTIGATOR
Rabin MC
Zvi Kaufman, Dr.
Role: PRINCIPAL_INVESTIGATOR
Meir MC
Tal Kopelman, Dr.
Role: PRINCIPAL_INVESTIGATOR
Bnei Zion Mc
Yuri Berlin, Dr.
Role: PRINCIPAL_INVESTIGATOR
HaEmek MC
Moshe Papa, Prof.
Role: PRINCIPAL_INVESTIGATOR
Sheba Mc
Tanir Allweis, Dr.
Role: PRINCIPAL_INVESTIGATOR
Haddasah Medical Organization
Shlomo Schneebaum, Prof.
Role: PRINCIPAL_INVESTIGATOR
Souraski MC
Moshe Carmon, Dr.
Role: PRINCIPAL_INVESTIGATOR
Shaare Zedek MC
Amram Adari, Dr.
Role: PRINCIPAL_INVESTIGATOR
Ziv Mc
Moshe Zilberman, Dr.
Role: PRINCIPAL_INVESTIGATOR
Poria MC
Locations
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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
Rivka Ziv MC
Safed, , Israel
Souraski MC
Tel Aviv, , Israel
Poria MC
Tiberias, , Israel
Countries
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Related Links
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Official company site
Other Identifiers
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CP-02-001
Identifier Type: -
Identifier Source: org_study_id