Feasibility Study: Ulthera Treatment of the Buttocks and Thighs
Up to 30 subjects will be enrolled. Enrolled subjects will receive an Ulthera® treatment to one side of the body, treating the lateral buttock region. 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.
|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 the Buttocks and Thighs|
- Overall lifting and tightening of the buttocks and thighs. [ Time Frame: 90 days post-treatment ] [ Designated as safety issue: No ]As determined by a masked, qualitative assessment of photographs at three months post-treatment compared to baseline.
- Overall aesthetic improvement. [ Time Frame: 90 and 180 days post-treatment. ] [ Designated as safety issue: No ]As determined by GAIS completed by the Investigator and subject.
- Overall subject satisfaction. [ Time Frame: 90 and 180 days post-treatment ] [ Designated as safety issue: No ]As determined by subjects' completion of a Patient Satisfaction Questionnaire.
|Study Start Date:||December 2011|
|Study Completion Date:||July 2013|
|Primary Completion Date:||January 2013 (Final data collection date for primary outcome measure)|
Experimental: Ulthera-treated subjects
All enrolled subjects will receive one Ultherapy treatment to one side of the body in the lateral buttock region. Following study completion, subjects may elect to receive a balancing treatment to the other side of the body.
Device: Ulthera System Treatment
Focused ultrasound energy delivered below the surface of the skin.
Other Name: Ultherapy™
This is a prospective, single-center, pilot clinical trial to evaluate the efficacy of the Ulthera® System to improve buttock and thigh skin laxity. Global Aesthetic Improvement Scale scores and patient satisfaction questionnaires will be obtained.
|United States, New York|
|Skin Laser and Surgery Specialist of New York and New Jersey|
|New York, New York, United States, 10022|
|Principal Investigator:||David Goldberg, MD||Skin Laser and Surgery Specialist of New York and New Jersey|