Clinical trialNCT00943605TerminatedInterventional

PEAK PlasmaBlade™ 4.0 Versus Traditional Electrosurgery in Mastectomy

SponsorMedtronic Surgical TechnologiesEnrollment60Mastectomy

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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 PlasmaBlade 4.0; to monitor and record operative performance, post-operative pain, drain output, and skin scarring following surgery; and to compare these endpoints to the current standard of care (SOC).

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Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

Edward Dalton, MD
Elliot Breast Health Center
Principal Investigator
clinicaltrials.gov ↗
Michael Schultz, MD
St. Joseph Medical Center
Principal Investigator
clinicaltrials.gov ↗
Peter Naruns, MD
Midpeninsula Surgical Associates
Principal Investigator
clinicaltrials.gov ↗
Richard Fine, MD
Advanced Breast Care
Principal Investigator
clinicaltrials.gov ↗
Saul Eisenstat, MD
Midpeninsula Surgical Associates
Principal Investigator
clinicaltrials.gov ↗
Teresa Ponn, MD
Elliot Breast Health Center
Principal Investigator
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

4 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

Providence St. Joseph'S Medical Center
Burbank, California, United States
El Camino Hospital
Mountain View, California, United States
Advanced Breast Care
Marietta, Georgia, United States
St. Joseph Medical Center
Towson, Maryland, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 30 Jun 2009
Primary completion: 31 Dec 2011
Completion: 31 Mar 2012
Last update posted: 8 Jan 2013
Registered enrollment: 60
Registry id: NCT00943605

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 4 Nov 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.