Trial Outcomes & Findings for PEAK PlasmaBlade™ 4.0 Versus Traditional Electrosurgery in Lumpectomy (NCT NCT00960154)

Results Overview

Overall histological quality score will be a composite of the histological metrics

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

50 participants

Primary outcome timeframe

Intraoperative

Results posted on

2013-01-08

Participant Flow

Participant milestones

Participant milestones
Measure	PlasmaBlade The entirety of the lumpectomy will be performed with the PEAK PlasmaBlade, including the skin incision.	Standard of Care (SOC) The SOC consists of scalpel for the skin incision and traditional electrosurgery for the entirety of the subcutaneous dissection.
Overall Study STARTED	25	25
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	25	25

Reasons for withdrawal

Reasons for withdrawal
Measure	PlasmaBlade The entirety of the lumpectomy will be performed with the PEAK PlasmaBlade, including the skin incision.	Standard of Care (SOC) The SOC consists of scalpel for the skin incision and traditional electrosurgery for the entirety of the subcutaneous dissection.
Overall Study Study termination	25	25

Baseline Characteristics

PEAK PlasmaBlade™ 4.0 Versus Traditional Electrosurgery in Lumpectomy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PlasmaBlade n=25 Participants The entirety of the lumpectomy will be performed with the PEAK PlasmaBlade, including the skin incision.	Standard of Care (SOC) n=25 Participants The SOC consists of scalpel for the skin incision and traditional electrosurgery for the entirety of the subcutaneous dissection.	Total n=50 Participants Total of all reporting groups
Age, Customized 18 to 90 years	25 participants n=5 Participants	25 participants n=7 Participants	50 participants n=5 Participants
Sex: Female, Male Female	25 Participants n=5 Participants	25 Participants n=7 Participants	50 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	25 participants n=5 Participants	25 participants n=7 Participants	50 participants n=5 Participants

PRIMARY outcome

Timeframe: Intraoperative

Population: An integrity audit found that the data for this study could not be analyzed owing to unverifiable source documentation.

Overall histological quality score will be a composite of the histological metrics

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Intraoperatively and 1-2 weeks postoperatively

Population: An integrity audit found that the data for this study could not be analyzed owing to unverifiable source documentation.

Outcome measures

Outcome data not reported

Adverse Events

PlasmaBlade

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard of Care (SOC)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	PlasmaBlade n=25 participants at risk The entirety of the lumpectomy will be performed with the PEAK PlasmaBlade, including the skin incision.	Standard of Care (SOC) n=25 participants at risk The SOC consists of scalpel for the skin incision and traditional electrosurgery for the entirety of the subcutaneous dissection.
Infections and infestations Postoperative axillary abcess with cellulitis	4.0% 1/25 • Number of events 1	0.00% 0/25

Other adverse events

Adverse event data not reported

Additional Information

Robert Swain, PhD

Medtronic Surgical Technologies

Phone: (+1-603) 294-5428

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60