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

This study has been terminated.
(Change in business priorities.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01100190
First Posted: April 8, 2010
Last Update Posted: August 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Ethicon, Inc.
  Purpose
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.

Condition Intervention
Ptosis of the Neck, Mid-face and/or Jowl Device: NUVANCE Facial Rejuvenation System

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Study of the NUVANCE Facial Rejuvenation System for Mid-Face, Neck and Jowl Rejuvenation Procedures

Further study details as provided by Ethicon, Inc.:

Primary Outcome Measures:
  • Composite incidence of adverse device events [ Time Frame: up to 30-days post-procedure ]
    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.


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 100
Actual Study Start Date: March 1, 2010
Study Completion Date: March 1, 2014
Primary Completion Date: April 1, 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01100190


Locations
France
Bernard Mole
Paris, France, 75007
Catherine Bergeret-Galley
Paris, France, 75008
Benjamin Ascher
Paris, France, 75116
Germany
Martin-Luther-Krankenhaus
Berlin, Germany, D-14193
Chirurgie Praxisklinik Kaiserplatz
Frankfurt, Germany, 60311
Rotes Kreuz Krankenhous Kassel
Kassel, Germany, 34121
Israel
Rambam Medical Center
Haifa, Israel, 31096
Rabin Medical Center
Petah Tikva, Israel, 49100
United Kingdom
Springfield Hospital
Springfield, United Kingdom, CM1 7GU
Sponsors and Collaborators
Ethicon, Inc.
Investigators
Study Director: Martin Weisberg, MD Ethicon, Inc.
  More Information

Responsible Party: Ethicon, Inc.
ClinicalTrials.gov Identifier: NCT01100190     History of Changes
Other Study ID Numbers: 200-08-001
First Submitted: April 7, 2010
First Posted: April 8, 2010
Last Update Posted: August 11, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Not an applicable trial, product manufactured outside of US and all study sites outside US.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ethicon, Inc.:
Facelift
Rhytidectomy
Ptosis