Feasibility Study: Evaluation of the Ulthera® System for Treatment of the Knees
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Feasibility Study: Evaluation of the Ulthera® System for Lifting and Tightening of the Knees|
- Improvement in overall lifting and tightening of knee skin laxity. [ Time Frame: 90 and 180 days post-treatment ] [ Designated as safety issue: No ]Assessed based on Principal Investigator assessment using the Global Aesthetic Improvement Scale.
- Overall improvement in skin laxity. [ Time Frame: 90 and 180 days post-treatment ] [ Designated as safety issue: No ]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.
|Study Start Date:||June 2011|
|Study Completion Date:||August 2012|
|Primary Completion Date:||May 2012 (Final data collection date for primary outcome measure)|
Experimental: Ulthera® treatment of the knees
Bilateral treatment of the knees using the Ulthera® System
Device: Ulthera® System
Focused ultrasound energy delivered below the surface of the skin
Other Name: Ultherapy™ treatment
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01708434
|United States, Tennessee|
|Tennessee Clinical Research Center|
|Nashville, Tennessee, United States, 37215|
|Principal Investigator:||Michael Gold, MD||Tennessee Clinical Research Center|