PEAK PlasmaBlade™ 4.0 Versus Traditional Electrosurgery in Lumpectomy

Stopped early · Not applicable

Conditions studied: Breast Cancer

In brief

The purpose of this clinical study is to quantify the difference in thermal injury depth at the surgical margin in breast lumpectomy specimens excised with the PlasmaBlade; to subjectively assess histopathologic sample quality metrics; to examine the role that electrosurgical artifact may play in revision lumpectomy procedures; and to compare these endpoints to the standard of care (SOC) technology.

Key facts

Study ID

NCT00960154

Run by

Medtronic Surgical Technologies

People needed

50

Starts

2009-07-01

Expected to finish

2012-02-01

Last updated by the study team

2013-01-08

Who can join

Age: 18 and older, up to 90. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Age between 18 and 90 years old
• Physically healthy, stable weight
• Requiring lumpectomy with wire localization for suspected or confirmed malignant breast disease.
• Subject must understand the nature of the procedure and provide written informed consent prior to the procedure.
• Subject must be willing and able to comply with all follow-up evaluations

You may not qualify if…

• Age younger than 18 or greater than 90 years old
• Infection (local or systemic)
• Cognitive impairment or mental illness
• Severe cardiopulmonary deficiencies
• Unable to follow instructions or complete follow-up
• Currently taking any medication known to affect healing
• Currently enrolled in another investigational device or drug trial

Where it is running

• El Camino Surgery Center — Mountain View, California, United States
• Palo Alto Medical Foundation — Mountain View, California, United States

Full record on ClinicalTrials.gov

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