Study Stopped
Change in business priorities.
Change in business priorities.
Sponsor study identifier
interventional
100
4 countries
9
Study Start
March 1, 2010
Actual (reported)Primary Completion
April 1, 2011
Actual (reported)Study Completion
March 1, 2014
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 1, 2014
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 1, 2010
Actual (reported)April 7, 2010
Actual (reported)April 8, 2010
Actual (reported)April 1, 2011
Actual (reported)March 1, 2014
Actual (reported)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
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
The NUVANCE™ Facial Rejuvenation System is a partially absorbable porous mesh device implant with applicator.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Bernard Mole
Paris, 75007, France
Catherine Bergeret-Galley
Paris, 75008, France
Benjamin Ascher
Paris, 75116, France
Martin-Luther-Krankenhaus
Berlin, D-14193, Germany
Chirurgie Praxisklinik Kaiserplatz
Frankfurt, 60311, Germany
Rotes Kreuz Krankenhous Kassel
Kassel, 34121, Germany
Rambam Medical Center
Haifa, 31096, Israel
Martin Weisberg, MD
Ethicon, Inc.
First Submitted
April 7, 2010
First Posted
April 8, 2010
Study Start
March 1, 2010
Actual (reported)Primary Completion
April 1, 2011
Actual (reported)Contact the study team to confirm eligibility.
Rabin Medical Center
Petah Tikva, 49100, Israel
Springfield Hospital
Springfield, CM1 7GU, United Kingdom
Study Completion
March 1, 2014
Actual (reported)Last Updated
August 11, 2017
Record last verified: 2017-08
Not an applicable trial, product manufactured outside of US and all study sites outside US.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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