NCT02270892

Ultherapy for Buttock Lift

Evaluation of the Ulthera® System for Lifting of the Buttock

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Ulthera, Inc · Industry
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

Up to 24 subjects will be enrolled and treated. Enrolled subjects will receive two Ulthera® treatments, 90 days apart. Follow-up visits will occur at 90, 180, and 270 days following the last treatment. Study images will be obtained pre-treatment, immediately post-treatment, and at each follow-up visit.

Detailed description

This study is a prospective, single-blinded, randomized, split-body clinical study to be conducted at one clinical site. Investigator will assess baseline buttock ptosis to confirm subject eligibility. Enrolled subjects meeting all entrance criteria and who are confirmed to be eligible for study treatment will be randomized/assigned into one of two treatment groups: "Right side treated" and "Left side treated". All subjects will receive two, single-sided, dual-depth Ultherapy® treatments using the 4-4.5mm and 7-3.0mm transducers at 0.90J and 0.30J, respectively. Standardized images will be taken using standard 2D and Vectra 3D digital imaging systems. Subjects completing all study visits will be given the option of receiving two balancing treatments, 90 days apart, and will be required to complete one study visit at 90 days following the last balancing treatment. Quantititative and qualititative assessment of pre- versus post-treatment buttock ptosis will be completed for each post-treatment time point. Subjects will also complete a questionnaire at each study visit.

Conditions

• Buttock Ptosis

Interventions

Type	Name	Description
DEVICE	Ulthera treatment	Focused ultrasound energy delivered below the surface of the skin

Timeline

• Start date: 2014-08-28
• Primary completion: 2016-07-22
• Completion: 2017-04-03
• First posted: 2014-10-21
• Last updated: 2018-01-31

Locations

1 site across 1 country: United States