Clinical trial NCT01100190: 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
Overall status: TERMINATED
Phase: NA
Conditions: Ptosis of the Neck, Mid-face and/or Jowl
Keywords: Facelift
Rhytidectomy
Ptosis
Lead sponsor: Ethicon, Inc.
Sponsor class: INDUSTRY
First posted: 2010-04-08
Enrollment: 100
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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):

  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.

Primary outcomes:
measure: Composite incidence of adverse device events
timeFrame: up to 30-days post-procedure
Secondary outcomes:
measure: Individual incidence of adverse device events
timeFrame: up to 3 yrs post-op
measure: Incidence of treatment failures and cosmetic re-intervention
timeFrame: up to 3 yrs post-op
measure: Quality of Life changes prior to and after surgery
timeFrame: up to 3 yrs post-op
measure: Global Improvement Assessment using standardized photographic images
timeFrame: up to 3 yrs post-op
Other outcomes:
Locations:
city: Paris
country: France
facility: Bernard Mole
city: Paris
country: France
facility: Catherine Bergeret-Galley
city: Paris
country: France
facility: Benjamin Ascher
city: Berlin
country: Germany
facility: Martin-Luther-Krankenhaus
city: Frankfurt
country: Germany
facility: Chirurgie Praxisklinik Kaiserplatz
city: Kassel
country: Germany
facility: Rotes Kreuz Krankenhous Kassel
city: Haifa
country: Israel
facility: Rambam Medical Center
city: Petah Tikva
country: Israel
facility: Rabin Medical Center
city: Springfield
country: United Kingdom
facility: Springfield Hospital
Study officials:
affiliation: Ethicon, Inc.
name: Martin Weisberg, MD
role: STUDY_DIRECTOR
References: