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

History of Changes

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

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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
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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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

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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

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1. Primary:

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

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2. Primary:

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

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3. Secondary:

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

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Serious Adverse Events

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Other Adverse Events

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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 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:

	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 less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

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.

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

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