Actively Recruiting
Safety and Effectiveness Evaluation of the High-intensity Focused Ultrasound Device for Lifting Lax Submental and Neck Tissue
Led by CLASSYS Inc. · Updated on 2026-04-20
273
Participants Needed
5
Research Sites
58 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Safety and Effectiveness Evaluation of the High-intensity Focused Ultrasound Device for Lifting Lax Submental and Neck Tissue
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female subjects aged 30 to 65 years at the time of consent
- Mild to moderate skin laxity in the submental and/or neck areas
- Good general health with stable body weight (±5%) for at least 6 months before screening
- Willingness to avoid other aesthetic or dermatologic procedures on the treatment area during the study
- Ability to understand, sign informed consent, and comply with study visits and procedures
- Female subjects of child-bearing potential agreeing to use reliable contraception throughout the study
You will not qualify if you...
- Prior facelift, neck lift, liposuction, or contouring surgery on the lower face, submental, or neck areas
- Treatment with energy-based or injectable aesthetic procedures on the treatment area within 6 months before baseline
- Presence of implanted electronic medical devices like pacemaker, defibrillator, or neurostimulator
- Active skin infection, wounds, cystic acne, inflammation, or severe scarring near the treatment area
- History of keloid formation or abnormal wound healing
- Known bleeding disorders or use of anticoagulant/antiplatelet medications that cannot be safely stopped
- Pregnancy or breastfeeding
- Known sensitivity or contraindication to ultrasound-based procedures
- Any medical or psychiatric condition that may interfere with study participation or safety
- Participation in another investigational study within 30 days before screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Dermatology
Los Angeles, California, United States, 90004
Actively Recruiting
2
Dermatology
Charlotte, North Carolina, United States, 28405
Actively Recruiting
3
Dermatology
Wilmington, North Carolina, United States, 28405
Actively Recruiting
4
Dermatology
Nashville, Tennessee, United States, 37203
Actively Recruiting
5
Dermatology
Spokane, Washington, United States, 99204
Actively Recruiting
Research Team
M
Megan Kim
CONTACT
J
James Lim
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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