Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

PEAK PlasmaBlade™ 4.0 Versus Traditional Electrosurgery in Mastectomy (PRECISE)

This study has been terminated.
(Termination due to acquisition of PEAK Surgical by Medtronic)
Sponsor:
Information provided by (Responsible Party):
Medtronic Surgical Technologies
ClinicalTrials.gov Identifier:
NCT00943605
First received: July 21, 2009
Last updated: January 3, 2013
Last verified: January 2013
Results First Received: November 29, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Treatment
Condition: Mastectomy
Interventions: Device: Scalpel and Traditional Electrosurgery
Device: PEAK PlasmaBlade

  Participant Flow
  Hide Participant Flow

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) Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.
PEAK PlasmaBlade The entirety of the mastectomy will be performed with the PEAK PlasmaBlade, including the skin incision.

Participant Flow:   Overall Study
    Standard of Care (SOC)     PEAK PlasmaBlade  
STARTED     30 [1]   30 [1]
COMPLETED     0     0  
NOT COMPLETED     30     30  
Study termination                 30                 30  
[1] There were 10 total subjects (5/group) who were retrospectively unenrolled for deviations.



  Baseline Characteristics
  Hide Baseline Characteristics

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.
No text entered.

Reporting Groups
  Description
Standard of Care (SOC) Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.
PEAK PlasmaBlade The entirety of the mastectomy will be performed with the PEAK PlasmaBlade, including the skin incision.
Total Total of all reporting groups

Baseline Measures
    Standard of Care (SOC)     PEAK PlasmaBlade     Total  
Number of Participants  
[units: participants]
  30     30     60  
Age, Customized [1]
[units: participants]
     
20 to 70 years     30     30     60  
Gender  
[units: participants]
     
Female     30     30     60  
Male     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     30     30     60  
[1] An integrity audit found that the data for this study could not be analyzed owing to unverifiable source documentation. The protocol-specified age range is used for this baseline measure.



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Total Serous Drainage (mL) From Time of Drain Placement to Removal.   [ Time Frame: 0 to 10 days postoperatively ]

2.  Primary:   Area of Skin Necrosis Measured With a Standard Ruler   [ Time Frame: 1 and 6 weeks postoperative ]

3.  Secondary:   Pain Score by Visual Analog Scale, Narcotic Consumption, Operative Time, Time to Surgical Drain Removal   [ Time Frame: 0 to 10 days postoperatively ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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
Upon Medtronic's acquisition of PEAK surgical, a study integrity audit was undertaken. Results of the audit showed that patient's rights and safety were maintained, but the source data, including baseline demographics, were unverifiable.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Robert Swain, PhD
Organization: Medtronic Surgical Technologies
phone: (+1-603) 294-5428
e-mail: robert.e.swain@medtronic.com


No publications provided


Responsible Party: Medtronic Surgical Technologies
ClinicalTrials.gov Identifier: NCT00943605     History of Changes
Other Study ID Numbers: PEAK VP-00074
Study First Received: July 21, 2009
Results First Received: November 29, 2012
Last Updated: January 3, 2013
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration