Ignite Creation Date:
2025-12-24 @ 2:52 PM
Ignite Modification Date:
2025-12-26 @ 4:51 PM
Study NCT ID:
NCT01234259
Status:
COMPLETED
Last Update Posted:
2020-04-16
First Post:
2010-11-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Safety and Efficacy of Using Venus Freeze™ (MP)2 V2 System for Wrinkles Rhytides and Cellulite Treatment
Sponsor:
Venus Concept
Organization:
Study Overview
Official Title:
Evaluation of Safety and Efficacy of Using Venus Freeze™ (MP)2 V2 System for Wrinkles Rhytides and Cellulite Treatment - a Pilot Study
Status:
COMPLETED
Status Verified Date:
2020-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Skin aging is a multifactorial process involving the 3 layers of the skin: Epidermis, dermis and hypodermis.
Radio-frequency (RF) devices have been used for many years for a variety of surgical applications. The energy delivery systems of these established monopolar devices used a 'conductive coupling' delivery system in which energy is concentrated at the periphery of the electrode.
Venus Concept has developed the Venus Freeze (MP)2 V2 system for wrinkles, rhytides and temporary cellulite and circumference reduction treatments. While treating wrinkles rhytides and cellulite, the treatments creates enough thermal effect to induce collagen remodeling with no ablative thermal damage in the epidermis or dermis.
Radio-frequency (RF) devices have been used for many years for a variety of surgical applications. The energy delivery systems of these established monopolar devices used a 'conductive coupling' delivery system in which energy is concentrated at the periphery of the electrode.
Venus Concept has developed the Venus Freeze (MP)2 V2 system for wrinkles, rhytides and temporary cellulite and circumference reduction treatments. While treating wrinkles rhytides and cellulite, the treatments creates enough thermal effect to induce collagen remodeling with no ablative thermal damage in the epidermis or dermis.
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?: