Feasibility Study: Evaluation of the Ulthera® System for Lifting and Tightening of the Knees
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Ulthera, Inc
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Improvement in overall lifting and tightening of knee skin laxity.
Study Overview
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 Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 30 Years to 65 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Female, aged 30 to 65 years.
- •Subject in good health.
- •Mild to moderate skin laxity around the knees.
- •Understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the follow-up period.
Exclusion Criteria
- •Presence of an active systemic or local skin disease that may affect wound healing.
- •Excessive subcutaneous fat around the knees.
- •Excessive skin laxity around the knees.
Arms & Interventions
Ulthera® treatment of the knees
Bilateral treatment of the knees using the Ulthera® System
Intervention: Ulthera® System (Device)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Overall improvement in skin laxity.(90 and 180 days post-treatment)