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Tests treatment safety and results for Skin Laxity (Submental and Neck)
Official title Safety and Effectiveness Evaluation of the High-intensity Focused Ultrasound Device for Lifting Lax Submental and Neck Tissue
ClinicalTrials.gov ID: NCT07229430
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 30 to 65. Healthy volunteers may be eligible.
You may be able to join if
- Male or female people aged 30 to 65 years, inclusive, at the time of informed consent.
- people presenting with mild to moderate submental and/or neck skin laxity, as determined by the investigator.
- people in good general health with stable body weight (±5%) for at least 6 months prior to screening.
- people willing to avoid other aesthetic or dermatologic procedures (surgical or non-surgical) to the treatment area during the study period.
- people able to understand and sign informed consent and comply with all study visits and procedures.
You likely can't join if
- 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...
- 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.
See the full eligibility criteria
- Male or female people aged 30 to 65 years, inclusive, at the time of informed consent.
- people presenting with mild to moderate submental and/or neck skin laxity, as determined by the investigator.
- people in good general health with stable body weight (±5%) for at least 6 months prior to screening.
- people willing to avoid other aesthetic or dermatologic procedures (surgical or non-surgical) to the treatment area during the study period.
- people able to understand and sign informed consent and comply with all study visits and procedures.
- Female people of child-bearing potential who agree to use reliable contraception throughout study participation.
- 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...
- 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.
- people 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.
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Charlotte, North Carolina, United States
- Wilmington, North Carolina, United States
- Nashville, Tennessee, United States
- Spokane, Washington, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 30 years to 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; Charlotte, North Carolina, United States; Wilmington, North Carolina, United States; Nashville, Tennessee, United States; Spokane, Washington, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.