PEAK PlasmaBlade™ vs. Traditional Electrosurgery in Abdominoplasty

Launched by MEDTRONIC SURGICAL TECHNOLOGIES · Jul 21, 2009

Keywords

ClinConnect Summary

Abdominoplasty is a cosmetic surgical procedure performed to correct abdominal elastosis with skin and fat redundancy. During the procedure, a scalpel and traditional electrosurgical device are used to cut away this excess skin and fat from the abdomen and the underlying muscles are tightened together with sutures.

The PEAK PlasmaBlade™ uses pulsed radiofrequency (RF) energy to enable precision cutting and coagulating at the point of application, without the thermal damage to surrounding tissues that is normally seen with traditional electrosurgery. The PlasmaBlade has received FDA clearan...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age between 25 and 60 years old
• • 2. Physically healthy, stable weight, non-smoker
• • 3. Protruding abdomen, excess fat and skin and/or weak abdominal muscles qualifying for abdominoplasty.
• • 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 specified follow-up evaluations.
• • 6. Female subjects must either be no longer capable of reproduction or taking acceptable measures to prevent pregnancy during the study, and have a negative pregnancy test prior to participation in the study.
• Exclusion Criteria:
• • 1. Age younger than 25 or greater than 60 years old
• • 2. Anticoagulation therapy which cannot be discontinued
• • 3. Smoking (any kind)
• • 4. Diabetes (any type)
• • 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. Subjects who are pregnant or lactating
• • 12. Currently taking any medication known to affect healing
• • 13. Subjects who are status-post gastric banding or gastric bypass
• • 14. Reproductive age females who will not take acceptable measures to prevent pregnancy during the study.
• • 15. Recent history of abdominal surgery or prior abdominoplasty.
• • 16. Subjects who are known to be HIV or Hepatitis (any) positive
• • 17. Currently enrolled in another investigational device or drug trial
• • 18. Unable to follow instructions or complete follow-up