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

NCT ID: NCT00380952

Last Updated: 2008-05-28

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Study Completion Date

2008-04-30

Brief Summary

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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

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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.

Conditions

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Breast Cancer

Keywords

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IDC DCIS ILC

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Interventions

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Dune Device

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Dune Medical Devices

INDUSTRY

Sponsor Role lead

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

Site Status

Rambam MC

Haifa, , Israel

Site Status

Haddasah Medical Organization

Jerusalem, , Israel

Site Status

Shaare Zedek

Jerusalem, , Israel

Site Status

Meir MC

Kfar Saba, , Israel

Site Status

Rabin MC

Petah Tikva, , Israel

Site Status

Rivka Ziv MC

Safed, , Israel

Site Status

Souraski MC

Tel Aviv, , Israel

Site Status

Poria MC

Tiberias, , Israel

Site Status

Countries

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Israel

Related Links

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http://www.dunemedical.com

Official company site

Other Identifiers

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CP-02-001

Identifier Type: -

Identifier Source: org_study_id