A Prospective Study of the NUVANCE Facial Rejuvenation System for Mid-Face, Neck and Jowl Rejuvenation Procedures

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.

Study Overview

• Status: Terminated
• Conditions: Ptosis of the Neck, Mid-face and/or Jowl
• Intervention / Treatment: Device: NUVANCE Facial Rejuvenation System

Detailed Description

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
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75007
    • Bernard Mole
  • Paris, France, 75008
    • Catherine Bergeret-Galley
  • Paris, France, 75116
    • Benjamin Ascher
• Germany
  • Berlin, Germany, D-14193
    • Martin-Luther-Krankenhaus
  • Frankfurt, Germany, 60311
    • Chirurgie Praxisklinik Kaiserplatz
  • Kassel, Germany, 34121
    • Rotes Kreuz Krankenhous Kassel
• Israel
  • Haifa, Israel, 31096
    • Rambam Medical Center
  • Petah Tikva, Israel, 49100
    • Rabin Medical Center
• United Kingdom
  • Springfield, United Kingdom, CM1 7GU
    • Springfield Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male or female subject older than 18 years.
• Subject is a candidate for minimally invasive, bilateral facial rejuvenation procedure using NUVANCETM Facial Rejuvenation System according to the device Instructions for Use (IFU).
• Subject is willing and able to provide informed consent and follow study-related requirements.

Exclusion Criteria:

• Subject who previously received surgical facial cosmetic treatment (procedure involving an incision):

  1. Within the last 12 months under the area of the forehead;
  2. Within the last 3 months within the area of the forehead where forehead is defined as the area above the imaginary anatomical line between the lateral canthus of the eye and the upper pole of the ear.
• Subject who previously received a cosmetic procedure with a dermal filler device and/or neurotoxin complex injectable within the last 9 months.
• Subjects with a permanent facial implant.
• Subjects planning on a cosmetic procedure with a permanent implant within 6-months of procedure.
• Subjects planning on a cosmetic procedure with a dermal filler device and/or neurotoxin complex injectable within 6-months of procedure.
• Subjects with significant ptosis where skin excision would be necessary.
• Subject has an active infection (e.g. acne, herpes zoster) or inflammation (e.g. psoriasis, pemphigus vulgaris, cutaneous lupus erythematosus) affecting facial skin.
• Subject has a history of a disorder that can affect wound healing (e.g. subjects pre-disposed to infection or history of keloid formation).
• Subject with pre-existing facial abnormalities (e.g. deformities, Bell's palsy, scarring)
• Subject with a significant psychiatric disorder judged by the clinical investigator that will interfere with the procedure
• Any pre-operative findings that the surgeon identifies that makes the subject not a candidate for a minimally invasive facial cosmetic surgical procedure.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: NUVANCE Facial Rejuvenation System	Device: NUVANCE Facial Rejuvenation System; The NUVANCE™ Facial Rejuvenation System is a partially absorbable porous mesh device implant with applicator.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	up to 30-days post-procedure

Secondary Outcome Measures

Outcome Measure	Time Frame
Individual incidence of adverse device events	up to 3 yrs post-op
Incidence of treatment failures and cosmetic re-intervention	up to 3 yrs post-op
Quality of Life changes prior to and after surgery	up to 3 yrs post-op
Global Improvement Assessment using standardized photographic images	up to 3 yrs post-op

Collaborators and Investigators

• Sponsor: Ethicon, Inc.

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2010
• Primary Completion (ACTUAL): April 1, 2011
• Study Completion (ACTUAL): March 1, 2014

Study Registration Dates

• First Submitted: April 7, 2010
• First Submitted That Met QC Criteria: April 7, 2010
• First Posted (ESTIMATE): April 8, 2010

Study Record Updates

• Last Update Posted (ACTUAL): August 11, 2017
• Last Update Submitted That Met QC Criteria: August 10, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: Ptosis; Facelift; Rhytidectomy
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Prolapse
• Other Study ID Numbers: 200-08-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Not an applicable trial, product manufactured outside of US and all study sites outside US.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No