Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 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. The trial reports 5 study locations across 4 states.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07229430
The ClinicalTrials.gov registry entry for NCT07229430 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 273 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is CLASSYS, which has 1 total studies on file at ClinicalTrials.gov.
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 reports 5 study locations spanning 4 distinct geographic areas - top geographies include 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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.