Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2026-01-01 @ 11:23 PM
Study NCT ID:
NCT01404351
Status:
WITHDRAWN
Last Update Posted:
2013-01-07
First Post:
2011-07-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of the PEAK PlasmaBlade 4.0 in Bilateral Breast Reduction
Sponsor:
Medtronic Surgical Technologies
Organization:
Study Overview
Official Title:
A Prospective, Randomized, Controlled Superiority Study to Evaluate Use of the PEAK PlasmaBlade® 4.0 in Bilateral Breast Reduction
Status:
WITHDRAWN
Status Verified Date:
2013-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study terminated due to the acquisition of PEAK Surgical by Medtronic
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: