Evaluation of Safety and Efficacy of Using Venus Freeze™ (MP)2 V2 System for Wrinkles Rhytides and Cellulite Treatment
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™ system for wrinkles, rhytides and cellulite treatment. While treating wrinkles rhytides and cellulite, the treatment creates enough thermal effect to induce collagen remodeling with no ablative thermal damage in the epidermis or dermis.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Evaluation of Safety and Efficacy of Using Venus Freeze™ (MP)2 V2 System for Wrinkles Rhytides and Cellulite Treatment - a Pilot Study|
- To evaluate the safety of the Venus system for wrinkles and rhytides treatment. [ Time Frame: 5 months ] [ Designated as safety issue: Yes ]Number of Participants with Adverse Events
- To evaluate the efficacy of the Venus Freeze™ system for wrinkles and rhytides treatment. [ Time Frame: 5 months ] [ Designated as safety issue: No ]Number of Participants that shows at least one degree improvement of skin elastosis according to Fitzpatrick Scale following treatment with Venus Freeze™ System.
|Study Start Date:||December 2010|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||July 2014 (Final data collection date for primary outcome measure)|
Experimental: Treament group
Venus Freeze (MP)2 V2 system treatments
Device: Venus Freeze™ system
10 RF treatments for wrinkles rhytides and cellulitis reduction by Venus Freeze System
No Intervention: control
control, no intervention
|Contact: Hanna Levy, Dr.||(972)-firstname.lastname@example.org|
|Sourasky medical Centre||Recruiting|
|Tel-Aviv, Israel, 64239|
|Contact: Hanna Levy, Dr. (972)-4-638-8837 email@example.com|
|Principal Investigator:||Eli Sprecher, Prof.||Tel-Aviv Sourasky medical Centre, Israel|