NCT03599349

Evaluation of the Ulthera® System and Efficacy Correlation to Morphological Differences

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Ulthera, Inc · Industry
• Sex: All
• Age: 30 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

Evaluate if there is a correlation between efficacy results and where the Thermal Coagulation Points (TCPs) produced during a treatment with the Ulthera System make contact with anatomical layers of the skin and underlying tissues.

Detailed description

This is a prospective, single-site, non-randomized study designed to evaluate if there is a correlation between efficacy results and where the Thermal Coagulation Points (TCPs), produced during treatment with the Ulthera System, make contact with the anatomical layers of skin and underlying tissues. The study consists of one Ultherapy treatment administered at two depths using DeepSEE transducers on the full-face and neck area. Ultrasound images will be captured at the beginning, middle and end of each treatment section during treatment.

Conditions

• Facial and Neck Skin Laxity

Interventions

Type	Name	Description
DEVICE	Microfocused ultrasound w/ visualization

Timeline

• Start date: 2015-08-20
• Primary completion: 2016-07-13
• Completion: 2016-07-13
• First posted: 2018-07-26
• Last updated: 2019-06-11
• Results posted: 2019-06-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study