PEAK PlasmaBlade™ 4.0 Versus Traditional Electrosurgery in Mastectomy
Launched by MEDTRONIC SURGICAL TECHNOLOGIES · Jul 21, 2009
Trial Information
Current as of July 24, 2025
Terminated
Keywords
ClinConnect Summary
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 and a traditional electrosurgical device is used to cut away the breast tissue from the chest and control bleeding. Once the breast tissue is removed the remaining skin edges are brought together with sutures.
Following mastectomy, the most common complication is persistent serous wound drainage and seroma, a collection of fluid in the closed surgical space. To help prevent this complication ...
Gender
FEMALE
Eligibility criteria
- Inclusion Criteria:
- • 1. Age between 20 and 70 years old
- • 2. Physically healthy, stable weight
- • 3. Requiring single or bilateral simple mastectomy, with or without sentinel lymph node biopsy
- • 4. Subject must understand the nature of the procedure and provide written informed consent prior to the procedure
- • 5. Subject must be willing and able to comply with all follow-up evaluations
- Exclusion Criteria:
- • 1. Age younger than 20 or greater than 70 years old
- • 2. Anticoagulation therapy which cannot be discontinued
- • 3. Prior external beam or implanted radiotherapy
- • 4. Tobacco use (any kind)
- • 5. Infection (local or systemic)
- • 6. Cognitive impairment or mental illness
- • 7. Severe cardiopulmonary deficiencies
- • 8. Known coagulopathy
- • 9. Immunocompromised
- • 10. Kidney disease (any type)
- • 11. Desiring or requiring same-day breast reconstruction
- • 12. Prior breast reduction or augmentation surgery
- • 13. Unable to follow instructions or complete follow-up
- • 14. Currently taking any medication known to affect healing
- • 15. Subjects who are status-post gastric banding or gastric bypass
- • 16. Currently enrolled in another investigational device or drug trial
- • 17. Time from most recent neoadjuvant therapy less than 4 weeks
About Medtronic Surgical Technologies
Medtronic Surgical Technologies is a leading global sponsor in the development and advancement of innovative surgical solutions aimed at improving patient outcomes and enhancing healthcare efficiency. As a division of Medtronic, a prominent player in the medical device industry, this entity focuses on pioneering technologies across a range of surgical disciplines, including minimally invasive procedures. With a commitment to clinical excellence and patient safety, Medtronic Surgical Technologies actively conducts clinical trials to evaluate the efficacy and effectiveness of its products, striving to set new standards in surgical care and support healthcare professionals in delivering optimal patient solutions.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Towson, Maryland, United States
Mountain View, California, United States
Burbank, California, United States
Marietta, Georgia, United States
Patients applied
Trial Officials
Teresa Ponn, MD
Principal Investigator
Elliot Breast Health Center
Edward Dalton, MD
Principal Investigator
Elliot Breast Health Center
Richard Fine, MD
Principal Investigator
Advanced Breast Care
Peter Naruns, MD
Principal Investigator
Midpeninsula Surgical Associates
Saul Eisenstat, MD
Principal Investigator
Midpeninsula Surgical Associates
Michael Schultz, MD
Principal Investigator
St. Joseph Medical Center
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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