Clinical Trial: Feasibility Study: Evaluation of the Ulthera® System for Treatment of the Knees

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Feasibility Study: Evaluation of the Ulthera® System for Lifting and Tightening of the Knees

Brief Summary: Enrolled subjects will receive one bilateral Ulthera® treatment on the knees. Up to 30 subjects will be enrolled. Study photos will be obtained prior to study treatment, immediately following study treatment, and at each post-treatment follow-up visit. Follow-up visits will occur at 90 and 180 days post-treatment.

Detailed Summary: This pilot study is a prospective, single-center clinical trial of the Ulthera® System for treating skin laxity on the knees. Global Aesthetic Improvement Scale scores and Patient Satisfaction questionnaires will be obtained at each follow-up visit.
Sponsor: Ulthera, Inc

Current Primary Outcome: Improvement in overall lifting and tightening of knee skin laxity. [ Time Frame: 90 and 180 days post-treatment ]

Assessed based on Principal Investigator assessment using the Global Aesthetic Improvement Scale.


Original Primary Outcome: Same as current

Current Secondary Outcome: Overall improvement in skin laxity. [ Time Frame: 90 and 180 days post-treatment ]

Determined based on a qualitative masked assessment comparing pre-treatment and post-treatment photographs; subjects' assessment based on the Subject Global Aesthetic Improvement Scale; completion of the Patient Satisfaction Questionnaire.


Original Secondary Outcome: Same as current

Information By: Ulthera, Inc

Dates:
Date Received: October 15, 2012
Date Started: June 2011
Date Completion:
Last Updated: June 27, 2013
Last Verified: June 2013