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

Ulthera

Status: Completed

Conditions: Skin Laxity

Treatments: Device: Ulthera® System

Study type: Interventional

Funder types: Industry

Identifiers

NCT01708434

ULT-115

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: Female

Ages: 30 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Ulthera® treatment of the knees

Experimental group

Description:

Bilateral treatment of the knees using the Ulthera® System

Treatment:

Device: Ulthera® System