Feasibility Study: Evaluation of the Ulthera® System for Treatment of Abdominal Tissue

Study Overview
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Brief Summary
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Enrolled subjects will receive one UltherapyTM treatment on the abdomen. Follow-up visits will occur at 90 and 180 days post-treatment. Study images will be obtained pre-treatment, immediately post-treatment, and at each follow-up visit.

Detailed Description
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This is a prospective, single-center, pilot clinical trial to evaluate the efficacy of the Ulthera® System for improving laxity/crepiness and texture of abdominal tissue. Changes from baseline in the laxity, crepiness and texture of abdominal skin will be assessed at each study follow-up visit. Global Aesthetic Improvement Scale scores, assessments of dermal thickness, and patient satisfaction questionnaires will also be obtained.

Official Title
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Feasibility Study: Evaluation of the Ulthera® System for Efficacious and Safe Treatment of Laxity/Crepiness and Texture of Abdominal Tissue

Conditions
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Skin Laxity, Skin Crepiness

Intervention / Treatment
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* Device: Ulthera System Treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female, aged 25 to 60 years. Subject in good health. Skin laxity in the abdomen Understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the follow-up period. Willingness and ability to comply with protocol requirements, including returning for follow-up visits and abstaining from exclusionary procedures for the duration of the study. Exclusion Criteria: Presence of an active systemic or local skin disease that may affect wound healing. Severe solar elastosis. Excessive subcutaneous fat in the abdomen. Excessive skin laxity on the abdomen. Significant scarring in areas to be treated. Open wounds or lesions in the area to be treated. Inability to understand the protocol or to give informed consent. BMI equal to and greater than 30.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study treatment<br>All enrolled subjects will receive one Ulthera System Treatment. | Device: Ulthera System Treatment<br>* Focused ultrasound energy delivered below the surface of the skin<br>* Other names: Ultherapy™;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement laxity/crepiness and texture of abdominal tissue | Determined by a masked, qualitative assessment of photographs at 90 days post treatment compared to baseline | 90 days post-treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall aesthetic improvement | The Global Aesthetic Improvement Scale scores will be obtained from the investigator and subject, comparing post-treatment photos to pre-treatment photos. | 180 days post-treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ulthera® System, Ultherapy™ Treatment, Ulthera, Inc., Ultrasound treatment for skin tightening