The objective of this study is to evaluate the clinical tolerability of the NUVANCE™ Facial Rejuvenation System for correcting neck, mid-face and/or jowl ptosis.
This is a multicenter, prospective, single-arm study. The primary tolerability endpoint will be evaluated up to 30-days post-operatively. Secondary endpoints will be evaluated at 6-months. Extended follow-up will be conducted at 12-months, 24-months, and 36-months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
The NUVANCE™ Facial Rejuvenation System is a partially absorbable porous mesh device implant with applicator.
Bernard Mole
Paris, France
Catherine Bergeret-Galley
Paris, France
Benjamin Ascher
Paris, France
Martin-Luther-Krankenhaus
Berlin, Germany
Composite incidence of adverse device events
The primary tolerability endpoint includes sensory nerve injury, skin necrosis, wound dehiscence, hypertrophic scarring, alopecia, surgical site infection, earlobe deformity, submental irregularity, hematomas, perforation, and palpability.
Time frame: up to 30-days post-procedure
Individual incidence of adverse device events
Time frame: up to 3 yrs post-op
Incidence of treatment failures and cosmetic re-intervention
Time frame: up to 3 yrs post-op
Quality of Life changes prior to and after surgery
Time frame: up to 3 yrs post-op
Global Improvement Assessment using standardized photographic images
Time frame: up to 3 yrs post-op
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Chirurgie Praxisklinik Kaiserplatz
Frankfurt, Germany
Rotes Kreuz Krankenhous Kassel
Kassel, Germany
Rambam Medical Center
Haifa, Israel
Rabin Medical Center
Petah Tikva, Israel
Springfield Hospital
Springfield, United Kingdom