Status:
TERMINATED
PEAK PlasmaBlade™ 4.0 Versus Traditional Electrosurgery in Lumpectomy
Lead Sponsor:
Medtronic Surgical Technologies
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-90 years
Phase:
NA
Brief Summary
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 hist...
Detailed Description
Lumpectomy is a surgical procedure performed to remove a localized mass of breast tissue that is suspicious for malignancy. The purpose of lumpectomy is to minimize the amount of tissue removed from t...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00960154
Start Date
July 1 2009
End Date
February 1 2012
Last Update
January 8 2013
Active Locations (2)
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1
El Camino Surgery Center
Mountain View, California, United States, 94040
2
Palo Alto Medical Foundation
Mountain View, California, United States, 94040