Clinical Research Directory
Browse clinical research sites, groups, and studies.
Safety and Effectiveness Evaluation of the High-intensity Focused Ultrasound Device for Lifting Lax Submental and Neck Tissue
Sponsor: CLASSYS Inc.
Summary
This is a prospective, multicenter, randomized, evaluator-blinded, parallel-controlled, non-inferiority clinical study designed to evaluate the safety and effectiveness of the ULTRAFORMER MPT PLUS, a high-intensity focused ultrasound (HIFU) device, for lifting and tightening lax submental (beneath the chin) and neck tissue in adult subjects. Approximately 273 subjects will be enrolled at multiple investigational sites across the United States. Participants will receive either the ULTRAFORMER MPT PLUS treatment or the predicate comparator device, and will be followed for safety and efficacy assessments including clinical photography, investigator evaluation, and patient-reported outcomes. The study aims to demonstrate that ULTRAFORMER MPT PLUS is non-inferior to the approved reference device in improving skin laxity and wrinkle appearance of the lower face and neck.
Official title: A Prospective, Multi-center, Randomized Controlled, Non-inferiority Study to Evaluate the Safety and Effectiveness of ULTRAFORMER MPT PLUS Treatment to Lift Lax Submental (Beneath the Chin) and Neck Tissue
Key Details
Gender
All
Age Range
30 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
273
Start Date
2025-10-16
Completion Date
2026-11-26
Last Updated
2025-12-01
Healthy Volunteers
Yes
Interventions
ULTRAFORMER MPT PLUS
ULTRAFORMER MPT PLUS (Classys Inc., Seoul, Korea) is a high-intensity focused ultrasound (HIFU) system that delivers focused energy at multiple depths to induce neocollagenesis and tissue contraction for non-surgical lifting and tightening of submental and neck tissue. The device includes both Default and MP modes and is under investigation under FDA IDE G250041.
Ulthera System
The Ulthera System (Merz Aesthetics, USA) is an FDA-cleared high-intensity focused ultrasound (HIFU) device indicated for non-invasive lifting and tightening of lax tissue in the submental and neck areas. It serves as the active comparator for this non-inferiority clinical study.
Locations (5)
Rebecca Fitzgerald, MD, Inc.
Los Angeles, California, United States
Dermatology, Laser & Vein Specialists of the Carolinas
Charlotte, North Carolina, United States
Wilmington Dermatology Center
Wilmington, North Carolina, United States
Nashville Centre for Laser and Facial Surgery
Nashville, Tennessee, United States
Spokane Dermatology Clinic / Werschler Aesthetics
Spokane, Washington, United States