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NCT07229430 · ClinicalTrials.gov registry record · NA
Safety and Effectiveness Evaluation of the High-intensity Focused Ultrasound Device for Lifting Lax Submental and Neck Tissue
A NA study of Skin Laxity (Submental and Neck) and Facial Skin Laxity, sponsored by CLASSYS.
- Recruiting
- Registry status
- NA
- Development phase
- 273
- Enrollment target
- 5
- Study locations
NCT07229430: Recruiting NA study of Skin Laxity (Submental and Neck) and Facial Skin Laxity, sponsored by CLASSYS.
NCT07229430 is a NA study of Skin Laxity (Submental and Neck) and Facial Skin Laxity that is actively recruiting participants, run by CLASSYS. The registered enrollment target is 273 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (81% lower). The trial reports 5 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07229430, a NA study of Skin Laxity (Submental and Neck) and Facial Skin Laxity, is actively recruiting participants, sponsored by CLASSYS.
- RECRUITING
- Registry status
- NA
- Development phase
- 273 participants
- Enrollment target
- 5
- Study locations
Study 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.
Primary Outcome
The primary endpoint of the study is the Submental Area Lift "Success" evaluated at 90 days post-treatment. A "Success" is defined as a reduction in the measured submental area of ≥ 20 mm² compared with baseline. Both left and right lateral 2D images will be derived from 3D photographs and analyzed by certified technicians using the Submental Lift Application (Canfield Scientific Inc.).
Conditions Studied
Interventions
- DEVICE ULTRAFORMER MPT PLUS
- DEVICE Ulthera System
Study Locations (5)
North Carolina
- Dermatology, Laser & Vein Specialists of the Carolinas - Charlotte
- Wilmington Dermatology Center - Wilmington
California
- Rebecca Fitzgerald, MD, Inc. - Los Angeles
Tennessee
- Nashville Centre for Laser and Facial Surgery - Nashville
Washington
- Spokane Dermatology Clinic / Werschler Aesthetics - Spokane
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 273 participants |
| Start Date | 2025-10-16 |
| Est. Completion | 2026-11-26 |
| Phase | NA |
What NCT07229430 shows while recruiting
NCT07229430 is an interventional study that assigns participants to a tested intervention. The registered 273 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (81% lower).
The record links to 3 conditions, with Skin Laxity (Submental and Neck) appearing as the primary indexed condition, and to 2 interventions - of which ULTRAFORMER MPT PLUS is the first listed.
NCT07229430 lists 5 locations in 4 states (North Carolina, California, Tennessee).
Frequently Asked Questions
What is clinical trial NCT07229430 about?
NCT07229430 is a clinical study titled "Safety and Effectiveness Evaluation of the High-intensity Focused Ultrasound Device for Lifting Lax Submental and Neck Tissue". 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 t...
What is the current status of trial NCT07229430?
This trial is currently recruiting. It is a NA study. The enrollment target is 273 participants. The study started on 2025-10-16. Estimated completion is 2026-11-26.
What conditions does trial NCT07229430 study?
This clinical trial studies the following conditions: Skin Laxity (Submental and Neck), Facial Skin Laxity, Submental Tissue Laxity.
What interventions are being tested in trial NCT07229430?
The interventions under investigation include: ULTRAFORMER MPT PLUS (DEVICE), Ulthera System (DEVICE).
Who is sponsoring clinical trial NCT07229430?
This trial is sponsored by CLASSYS, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07229430 being conducted?
This trial has 5 study locations across California, North Carolina, Tennessee, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07229430's enrollment target sits among peer trials
273 386th of 2000 higher than 1,615 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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