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 range

18 Years – 70 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

View on ClinicalTrials.gov More Macromastia (Symptomatic) trials