Ptosis of the Neck, Mid-face and/or Jowl Clinical Trial
Official title:
A Prospective Study of the NUVANCE Facial Rejuvenation System for Mid-Face, Neck and Jowl Rejuvenation Procedures
| Verified date | August 2017 |
| Source | Ethicon, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Terminated |
| Enrollment | 100 |
| Est. completion date | March 1, 2014 |
| Est. primary completion date | April 1, 2011 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 19 Years and older |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| France | Benjamin Ascher | Paris | |
| France | Bernard Mole | Paris | |
| France | Catherine Bergeret-Galley | Paris | |
| Germany | Martin-Luther-Krankenhaus | Berlin | |
| Germany | Chirurgie Praxisklinik Kaiserplatz | Frankfurt | |
| Germany | Rotes Kreuz Krankenhous Kassel | Kassel | |
| Israel | Rambam Medical Center | Haifa | |
| Israel | Rabin Medical Center | Petah Tikva | |
| United Kingdom | Springfield Hospital | Springfield |
| Lead Sponsor | Collaborator |
|---|---|
| Ethicon, Inc. |
France, Germany, Israel, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Individual incidence of adverse device events | up to 3 yrs post-op | ||
| Secondary | Incidence of treatment failures and cosmetic re-intervention | up to 3 yrs post-op | ||
| Secondary | Quality of Life changes prior to and after surgery | up to 3 yrs post-op | ||
| Secondary | Global Improvement Assessment using standardized photographic images | up to 3 yrs post-op |