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RECRUITING
NCT07229430
NA

Safety and Effectiveness Evaluation of the High-intensity Focused Ultrasound Device for Lifting Lax Submental and Neck Tissue

Sponsor: CLASSYS Inc.

View on ClinicalTrials.gov

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

DEVICE

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.

DEVICE

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