MarginProbe, a Device for Intraoperative Assessment of Margin Status in Breast Conservation Surgery (Pivotal)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dune Medical Devices
ClinicalTrials.gov Identifier:
NCT00749931
First received: September 7, 2008
Last updated: May 26, 2014
Last verified: May 2014
Results First Received: May 26, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Supportive Care
Condition: Breast Cancer
Interventions: Device: MarginProbe
Procedure: Lumpectomy

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Standard of Care (SOC)

Standard of Care arm - standard of care lumpectomy procedure

Lumpectomy: Standard of care lumpectomy procedure

Device + (Standard of Care) SOC

Use of the device in addition to the standard of care lumpectomy procedure.

MarginProbe: Device use to assess margin status of the excised specimen surface.

Lumpectomy: Standard of care lumpectomy procedure

Roll-in

Use of the device in addition to the standard of care lumpectomy procedure.

MarginProbe: Device use to assess margin status of the excised specimen surface.

Lumpectomy: Standard of care lumpectomy procedure


Participant Flow:   Overall Study
    Standard of Care (SOC)     Device + (Standard of Care) SOC     Roll-in  
STARTED     298     298     68  
COMPLETED     298     298     68  
NOT COMPLETED     0     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Standard of Care (SOC)

Standard of Care arm - standard of care lumpectomy procedure

Lumpectomy: Standard of care lumpectomy procedure

Device + (Standard of Care) SOC

Use of the device in addition to the standard of care lumpectomy procedure.

MarginProbe: Device use to assess margin status of the excised specimen surface.

Lumpectomy: Standard of care lumpectomy procedure

Total Total of all reporting groups

Baseline Measures
    Standard of Care (SOC)     Device + (Standard of Care) SOC     Total  
Number of Participants  
[units: participants]
  298     298     596  
Age  
[units: years]
Mean ± Standard Deviation
  60.2  ± 11.1     60.3  ± 11.4     60.3  ± 11.3  
Gender  
[units: participants]
     
Female     298     298     596  
Male     0     0     0  



  Outcome Measures
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1.  Primary:   The Primary Effectiveness Endpoint is a Measure of Intraoperative Success in Addressing Positive Margins as Detected by Permanent Pathology)by Additional Oriented Tissue Re-excision From the Surgical Cavity.   [ Time Frame: two weeks after surgery ]

2.  Post-Hoc:   Re-excision Lumpectomy Procedures Due to Positive Margin on Main Specimens   [ Time Frame: Up to 2 months post-surgery ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Clinical Research Manager
Organization: Dune Medical Devices
phone: +97246178000
e-mail: shiri@dunemedical.com


Publications of Results:

Responsible Party: Dune Medical Devices
ClinicalTrials.gov Identifier: NCT00749931     History of Changes
Other Study ID Numbers: CP-03-001
Study First Received: September 7, 2008
Results First Received: May 26, 2014
Last Updated: May 26, 2014
Health Authority: United States: Food and Drug Administration
Israel: Ministry of Health