WithdrawnNot Applicable

Use of the PEAK PlasmaBlade 4.0 in Bilateral Breast Reduction

Stopped: Study terminated due to the acquisition of PEAK Surgical by Medtronic

United States0Started 2011-05

Plain-language summary

The objective of this clinical study is to evaluate the operative performance of the PEAK PlasmaBlade® 4.0 during bilateral breast reduction; to monitor and record post-operative pain, adverse events and skin scarring following surgery; and to compare these outcomes to the HARMONIC SYNERGY® BLADE.

Who can participate

Age range18 Years – 70 Years

SexFEMALE

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Inclusion criteria

✓. Age between 18 and 70
✓. Physically healthy, stable weight
✓. No smoking \<1 month prior to surgery and during study.
✓. Desiring bilateral breast reduction
✓. 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 specified follow-up evaluations.
✓. Female subjects must either be incapable of reproduction, or taking acceptable measures to prevent pregnancy and have a negative pregnancy test prior to participation in the study.

Exclusion criteria

✕. Age younger than 18 or greater than 70 years old
✕. Anticoagulation therapy which cannot be discontinued
✕. Smoking \<1 month prior to surgery or during study
✕. Infection (local or systemic)
✕. Cognitive impairment or mental illness
✕. Severe cardiopulmonary deficiencies
✕. Known coagulopathy

What they're measuring

Difference in pain

Timeframe: 24 hours and first 10 days post-op

Trial details

NCT IDNCT01404351

SponsorMedtronic Surgical Technologies

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2011-10

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