NCT01100190

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Ethicon, Inc. · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
DEVICE	NUVANCE Facial Rejuvenation System	The NUVANCE™ Facial Rejuvenation System is a partially absorbable porous mesh device implant with applicator.

Timeline

• Start date: 2010-03-01
• Primary completion: 2011-04-01
• Completion: 2014-03-01
• First posted: 2010-04-08
• Last updated: 2017-08-11

Locations

9 sites across 4 countries: France, Germany, Israel, United Kingdom