Status:
TERMINATED
PEAK PlasmaBlade™ 4.0 Versus Traditional Electrosurgery in Mastectomy
Lead Sponsor:
Medtronic Surgical Technologies
Conditions:
Mastectomy
Eligibility:
FEMALE
20-70 years
Phase:
NA
Brief Summary
The objective of this clinical study is to evaluate the incidence of partial skin necrosis following modified-radical mastectomy with or without same-day (two-stage) reconstruction with the PEAK Plasm...
Detailed Description
Mastectomy is a surgical procedure performed to remove breast tissue that contains cancer, or has a high probability of containing cancer. During the procedure, a scalpel is used for the skin incision...
Eligibility Criteria
Inclusion
- Age between 20 and 70 years old
- Physically healthy, stable weight
- Requiring single or bilateral simple mastectomy, with or without sentinel lymph node biopsy
- 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 20 or greater than 70 years old
- Anticoagulation therapy which cannot be discontinued
- Prior external beam or implanted radiotherapy
- Tobacco use (any kind)
- Infection (local or systemic)
- Cognitive impairment or mental illness
- Severe cardiopulmonary deficiencies
- Known coagulopathy
- Immunocompromised
- Kidney disease (any type)
- Desiring or requiring same-day breast reconstruction
- Prior breast reduction or augmentation surgery
- Unable to follow instructions or complete follow-up
- Currently taking any medication known to affect healing
- Subjects who are status-post gastric banding or gastric bypass
- Currently enrolled in another investigational device or drug trial
- Time from most recent neoadjuvant therapy less than 4 weeks
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00943605
Start Date
June 1 2009
End Date
March 1 2012
Last Update
January 8 2013
Active Locations (4)
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1
Providence St. Joseph's Medical Center
Burbank, California, United States, 94505
2
El Camino Hospital
Mountain View, California, United States, 94040
3
Advanced Breast Care
Marietta, Georgia, United States, 30060
4
St. Joseph Medical Center
Towson, Maryland, United States, 21204