Back to resultsA Prospective Study of the NUVANCE Facial Rejuvenation System for Mid-Face, Neck and Jowl Rejuvenation Procedures
Primary Purpose
Ptosis of the Neck, Mid-face and/or Jowl
Status
Terminated
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
NUVANCE Facial Rejuvenation System
Sponsored by
About this trial
This is an interventional treatment trial for Ptosis of the Neck, Mid-face and/or Jowl focused on measuring Facelift, Rhytidectomy, Ptosis
Eligibility 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):
- Within the last 12 months under the area of the forehead;
- 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.
Sites / Locations
- Bernard Mole
- Catherine Bergeret-Galley
- Benjamin Ascher
- Martin-Luther-Krankenhaus
- Chirurgie Praxisklinik Kaiserplatz
- Rotes Kreuz Krankenhous Kassel
- Rambam Medical Center
- Rabin Medical Center
- Springfield Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
NUVANCE Facial Rejuvenation System
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Individual incidence of adverse device events
Incidence of treatment failures and cosmetic re-intervention
Quality of Life changes prior to and after surgery
Global Improvement Assessment using standardized photographic images
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01100190
Brief Title
A Prospective Study of the NUVANCE Facial Rejuvenation System for Mid-Face, Neck and Jowl Rejuvenation Procedures
Official Title
A Prospective Study of the NUVANCE Facial Rejuvenation System for Mid-Face, Neck and Jowl Rejuvenation Procedures
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Terminated
Why Stopped
Change in business priorities.
Study Start Date
March 1, 2010 (Actual)
Primary Completion Date
April 1, 2011 (Actual)
Study Completion Date
March 1, 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ethicon, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ptosis of the Neck, Mid-face and/or Jowl
Keywords
Facelift, Rhytidectomy, Ptosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
NUVANCE Facial Rejuvenation System
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
NUVANCE Facial Rejuvenation System
Intervention Description
The NUVANCE™ Facial Rejuvenation System is a partially absorbable porous mesh device implant with applicator.
Primary Outcome Measure Information:
Title
Composite incidence of adverse device events
Description
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
Secondary Outcome Measure Information:
Title
Individual incidence of adverse device events
Time Frame
up to 3 yrs post-op
Title
Incidence of treatment failures and cosmetic re-intervention
Time Frame
up to 3 yrs post-op
Title
Quality of Life changes prior to and after surgery
Time Frame
up to 3 yrs post-op
Title
Global Improvement Assessment using standardized photographic images
Time Frame
up to 3 yrs post-op
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility 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):
Within the last 12 months under the area of the forehead;
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Weisberg, MD
Organizational Affiliation
Ethicon, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Bernard Mole
City
Paris
ZIP/Postal Code
75007
Country
France
Facility Name
Catherine Bergeret-Galley
City
Paris
ZIP/Postal Code
75008
Country
France
Facility Name
Benjamin Ascher
City
Paris
ZIP/Postal Code
75116
Country
France
Facility Name
Martin-Luther-Krankenhaus
City
Berlin
ZIP/Postal Code
D-14193
Country
Germany
Facility Name
Chirurgie Praxisklinik Kaiserplatz
City
Frankfurt
ZIP/Postal Code
60311
Country
Germany
Facility Name
Rotes Kreuz Krankenhous Kassel
City
Kassel
ZIP/Postal Code
34121
Country
Germany
Facility Name
Rambam Medical Center
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
Rabin Medical Center
City
Petah Tikva
ZIP/Postal Code
49100
Country
Israel
Facility Name
Springfield Hospital
City
Springfield
ZIP/Postal Code
CM1 7GU
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Not an applicable trial, product manufactured outside of US and all study sites outside US.
Learn more about this trial
A Prospective Study of the NUVANCE Facial Rejuvenation System for Mid-Face, Neck and Jowl Rejuvenation Procedures
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