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

Sponsor
Dune Medical Devices (Industry)
Overall Status
Completed
CT.gov ID
NCT00380952
Collaborator
(none)
300
Enrollment
9
Locations
17
Duration (Months)
33.3
Patients Per Site
2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Dune Device
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
300 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
MAST Study Protocol
Study Start Date :
Nov 1, 2006
Actual Primary Completion Date :
Oct 1, 2007
Actual Study Completion Date :
Apr 1, 2008

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No

    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 HaEmek Mc Afula Israel
    2 Rambam MC Haifa Israel
    3 Haddasah Medical Organization Jerusalem Israel
    4 Shaare Zedek Jerusalem Israel
    5 Meir MC Kfar Saba Israel
    6 Rabin MC Petah Tikva Israel
    7 Souraski MC Tel- Aviv Israel
    8 Poria MC Tiberia Israel
    9 Rivka Ziv MC Zefat Israel

    Sponsors and Collaborators

    • Dune Medical Devices

    Investigators

    • Principal Investigator: Dan Hershko, Dr., Rambam MC
    • Principal Investigator: Rona Spector, Dr., Rabin MC
    • Principal Investigator: Eran Sharon, Rabin MC
    • Principal Investigator: Zvi Kaufman, Dr., Meir MC
    • Principal Investigator: Tal Kopelman, Dr., Bnei Zion Mc
    • Principal Investigator: Yuri Berlin, Dr., HaEmek MC
    • Principal Investigator: Moshe Papa, Prof., Sheba Mc
    • Principal Investigator: Tanir Allweis, Dr., Haddasah Medical Organization
    • Principal Investigator: Shlomo Schneebaum, Prof., Souraski MC
    • Principal Investigator: Moshe Carmon, Dr., Shaare Zedek MC
    • Principal Investigator: Amram Adari, Dr., Ziv Mc
    • Principal Investigator: Moshe Zilberman, Dr., Poria MC

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00380952
    Other Study ID Numbers:
    • CP-02-001
    First Posted:
    Sep 27, 2006
    Last Update Posted:
    May 28, 2008
    Last Verified:
    May 1, 2008
    Keywords provided by , ,
    IDC
    DCIS
    ILC

    Study Results

    No Results Posted as of May 28, 2008