Safety and Effectiveness Evaluation of the High-intensity Focused Ultrasound Device for Lifting Lax Submental and Neck Tissue
NCT07229430
This study is recruiting at 5 US sites in 4 states, according to its ClinicalTrials.gov record last updated .
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.
Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov
Conditions studied
- Skin Laxity (Submental and Neck)
- Facial Skin Laxity
- Submental Tissue Laxity
Eligibility basics and study details
- Study type
- Interventional
- Phase
- Not applicable
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Sponsor
- CLASSYS Inc.
- Last updated on ClinicalTrials.gov
- April 20, 2026
These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.
US recruiting sites
California · 1
- Dermatology · Los Angeles, CA
North Carolina · 2
- Dermatology · Charlotte, NC
- Dermatology · Wilmington, NC
Tennessee · 1
- Dermatology · Nashville, TN
Washington · 1
- Dermatology · Spokane, WA
Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.