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

Ethicon

Status

Terminated

Conditions

Ptosis of the Neck, Mid-face and/or Jowl

Treatments

Device: NUVANCE Facial Rejuvenation System

Study type

Interventional

Funder types

Industry

Identifiers

NCT01100190

200-08-001

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 estimated patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

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.