NCT03545412

Clinical Study on the Application of a Non-Invasive Micro-Focused Ultrasound With Visualization System for Skin Laxity (ULT-215)

Clinical Study on the Application of a Non-Invasive Micro-Focused Ultrasound With Visualization System for Skin Laxity

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Ulthera, Inc · Industry
• Sex: All
• Age: 39 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the effect of the Ulthera® system for facial laxity and sagging skin

Conditions

• Facial Skin Laxity

Interventions

Type	Name	Description
DEVICE	Microfocused ultrasound with visualization	Each subject to receive a minimum of 800 treatment lines, on two planes of treatment using the 4-4.5mm and 7-3.0mm transducer depths

Timeline

• Start date: 2014-01-10
• Primary completion: 2014-05-20
• Completion: 2014-08-20
• First posted: 2018-06-04
• Last updated: 2018-12-12
• Results posted: 2018-12-12

Regulatory

• FDA-regulated device study