Nashville, TNNCT07229430Now EnrollingIRB Ready

Skin Laxity (Submental and Neck) Clinical Trial in Nashville, TN

Access cutting-edge skin laxity (submental and neck) treatment through this clinical trial at a research site in Nashville. Study-provided care at no cost to qualified participants.

Sponsored by CLASSYS Inc.

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Expert Care in Nashville

Access skin laxity (submental and neck) specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related skin laxity (submental and neck) treatment provided free

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Check if you qualify for this skin laxity (submental and neck) clinical trial in Nashville, TN

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Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to Nashville

    Convenient for TN residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Nashville site if eligible
  4. 4Begin participation

About This Skin Laxity (Submental and Neck) Study in Nashville

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.

Sponsor: CLASSYS Inc.

Who Can Participate

Inclusion Criteria

Male or female subjects aged 30 to 65 years, inclusive, at the time of informed consent.
Subjects presenting with mild to moderate submental and/or neck skin laxity, as determined by the investigator.
Subjects in good general health with stable body weight (±5%) for at least 6 months prior to screening.
Subjects willing to avoid other aesthetic or dermatologic procedures (surgical or non-surgical) to the treatment area during the study period.
Subjects able to understand and sign informed consent and comply with all study visits and procedures.
Female subjects of child-bearing potential who agree to use reliable contraception throughout study participation.

Exclusion Criteria

Prior facelift, neck lift, liposuction, or contouring surgery involving the lower face, submental, or neck areas.
Receipt of any energy-based aesthetic treatment (e.g., HIFU, radiofrequency, laser) or injectable aesthetic treatment (e.g., botulinum toxin, dermal filler, collagen stimulator) to the treatment area within 6 months prior to baseline.
Presence of any implanted electronic medical device, such as a pacemaker, defibrillator, or neurostimulator.
Active skin infection, wound, cystic acne, inflammation, or severe scarring within or near the treatment area.
History of keloid formation or abnormal wound healing.
Known bleeding disorder, or use of anticoagulant or antiplatelet medications that cannot be safely discontinued for the procedure.
Pregnant or breastfeeding women.
Subjects with a known sensitivity or contraindication to ultrasound-based procedures.
Any medical or psychiatric condition that, in the investigator's judgment, could interfere with study participation, safety, or data integrity.
Participation in another investigational study within 30 days prior to screening.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Nashville?

Yes, this clinical trial (NCT07229430) has an active research site in Nashville, TN that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Skin Laxity (Submental and Neck) Treatment Options in Nashville, TN

If you're searching for skin laxity (submental and neck) treatment options in Nashville, TN, this clinical trial (NCT07229430) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Nashville research site is actively enrolling participants for this clinical trial. You'll receive care from experienced skin laxity (submental and neck) specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all skin laxity (submental and neck) clinical trials near you to find additional studies recruiting in your area.

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