A nagy intenzitású fókuszált ultrahang készülék biztonságosságának és hatékonyságának értékelése a megereszkedett áll- és nyaktörzs szövetek feszesítésére
Egy prospektív, multicentrikus, randomizált kontrollált, nem-inferioritási vizsgálat a ULTRAFORMER MPT PLUS kezelés biztonságosságának és hatékonyságának értékelésére a laza submentális (az áll alatti) és nyaki szövet felemelésére
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.
A tanulmány áttekintése
Állapot
Beavatkozás / kezelés
Részletes leírás
This prospective, multicenter, randomized, evaluator-blinded, parallel-controlled, non-inferiority clinical investigation is conducted under an FDA Investigational Device Exemption to evaluate the safety and effectiveness of the ULTRAFORMER MPT PLUS (Class II high-intensity focused ultrasound system) for aesthetic improvement of submental and neck tissue laxity.
A total of approximately 273 subjects aged 30-65 years with mild-to-moderate skin laxity in the submental and neck areas will be enrolled across up to 5 U.S. investigational sites. Subjects will be randomized 1:1 to receive either ULTRAFORMER MPT PLUS or the comparator device (ULTHERA® System, Merz Aesthetics, USA).
Primary endpoints include blinded investigator-assessed improvement using the validated Facial Laxity Grading Scale and safety outcomes based on the incidence and severity of device-related adverse events. Secondary endpoints include participant-reported improvement scores, digital image analysis, and durability of effect at 8-week and 12-week follow-ups.
The study consists of two sequential safety stages (Stage 1A and 1B; 20 subjects total) followed by the pivotal Stage 2 phase (approximately 253 subjects). Data from the safety stages will be reviewed by an independent Data Safety Monitoring Board (DSMB) prior to progression to Stage 2.
All treatments will be performed by trained investigators according to the protocol-defined parameters. Subjects will be evaluated at baseline, post-treatment, and during follow-up visits up to 6 months. The final statistical analysis will assess non-inferiority of ULTRAFORMER MPT PLUS to the predicate device with respect to the primary efficacy endpoint and confirm overall safety.
Tanulmány típusa
Beiratkozás (Becsült)
Fázis
- Nem alkalmazható
Kapcsolatok és helyek
Tanulmányi helyek
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California
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Los Angeles, California, Egyesült Államok, 90004
- Dermatology
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North Carolina
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Charlotte, North Carolina, Egyesült Államok, 28405
- Dermatology
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Wilmington, North Carolina, Egyesült Államok, 28405
- Dermatology
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Tennessee
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Nashville, Tennessee, Egyesült Államok, 37203
- Dermatology
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Washington
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Spokane, Washington, Egyesült Államok, 99204
- Dermatology
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Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
Egészséges önkénteseket fogad
Tanulmányozható nemek
Leírás
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.
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Kezelés
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Párhuzamos hozzárendelés
- Maszkolás: Egyetlen
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
|---|---|
|
Kísérleti: ULTRAFORMER MPT PLUS Group
ULTRAFORMER MPT PLUS (Classys Inc., Seoul, Korea) delivers high-intensity focused ultrasound (HIFU) energy to the subdermal tissue to induce neocollagenesis and tissue contraction for non-surgical skin tightening and lifting. |
ULTRAFORMER MPT PLUS (Classys Inc., Seoul, Korea) is a high-intensity focused ultrasound (HIFU) system that delivers focused energy at multiple depths to induce neocollagenesis and tissue contraction for non-surgical lifting and tightening of submental and neck tissue. The device includes both Default and MP modes and is under investigation under FDA IDE G250041. |
|
Aktív összehasonlító: Ulthera Comparator Group
The Ulthera® System (Merz Aesthetics, USA) uses focused ultrasound energy to lift and tighten submental and neck skin and serves as the reference comparator in this non-inferiority clinical trial. |
The Ulthera System (Merz Aesthetics, USA) is an FDA-cleared high-intensity focused ultrasound (HIFU) device indicated for non-invasive lifting and tightening of lax tissue in the submental and neck areas. It serves as the active comparator for this non-inferiority clinical study. |
Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Submental Area Lift [Time Frame: 90 Days Post-Treatment]
Időkeret: 90 Days Post-Treatment
|
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.). |
90 Days Post-Treatment
|
Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Submental Area Lift [Time Frame: 60 Days Post-Treatment]
Időkeret: 60 Days Post-Treatment
|
Submental Area Lift ≥ 20 mm² vs baseline. |
60 Days Post-Treatment
|
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Submental Area Lift [Time Frame: 90 Days Post-Treatment]
Időkeret: 90 Days Post-Treatment
|
Submental Area Lift ≥ 20 mm² vs baseline. |
90 Days Post-Treatment
|
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Change in Overall Lifting of Treated Tissue on Submental and Neck Regions [Time Frame: 60 and 90 Days Post-Treatment]
Időkeret: 60 and 90 Days Post-Treatment
|
Percentage of patients assessed to have improvement in skin laxity (lifted skin) by ≥ 2 of 3 independent blinded evaluators comparing pre-, 60-, and 90-day post-treatment images. Images will be prepared and randomized for review per Canfield SOPs (FDA K121700). |
60 and 90 Days Post-Treatment
|
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Global Aesthetic Improvement Scale (GAIS) Results [Time Frame: 60 and 90 Days Post-Treatment]
Időkeret: 60 and 90 Days Post-Treatment
|
Overall aesthetic improvement rated on a 5-point scale (1 = Very Much Improved to 5 = Worse) by the investigator comparing pre- and post-treatment photographs. Assessed by PI or delegated qualified staff at each visit. |
60 and 90 Days Post-Treatment
|
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Subject Satisfaction Questionnaire[Time Frame: 60 and 90 Days Post-Treatment]
Időkeret: 60 and 90 Days Post-Treatment
|
5-point Likert scale (1 = Very Satisfied to 5 = Very Dissatisfied). "Satisfied" = Very Satisfied or Satisfied. Completed at each follow-up visit. |
60 and 90 Days Post-Treatment
|
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Visual Analog Scale (VAS) - Pain Score[Time Frame:Immediately Post-Treatment]
Időkeret: Immediately Post-Treatment
|
Subject-reported pain (0 = No pain, 10 = Worst pain possible) recorded immediately after treatment completion. Pain management at investigator's discretion; if applicable, documented as AE. |
Immediately Post-Treatment
|
Együttműködők és nyomozók
Szponzor
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete (Tényleges)
Elsődleges befejezés (Becsült)
A tanulmány befejezése (Becsült)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Tényleges)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
Kulcsszavak
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- CS-483
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
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