Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

Safety and Efficacy Evaluation of the Xerf Device for Aesthetic Treatments

8 mei 2026 bijgewerkt door: CynosureLutronic

Safety and Efficacy Evaluation of the XERF Device for Aesthetic Treatments

The goal of this clinical study is to evaluate the safety and clinical effectiveness of the XERF noninvasive dual-frequency monopolar radiofrequency device for aesthetic improvement of facial aging, including fine lines and wrinkles, eyebrow lifting, and tightening of lax tissue in the lower face, submental area, and neck in healthy adults.

Up to 60 participants may be enrolled across up to five clinical sites in the United States. Participants receive XERF treatments using 6.78 MHz and 2.0 MHz energy; most undergo two sessions approximately four weeks apart (the protocol allows up to three). Standardized photographs are taken at baseline and follow-up visits.

Outcomes are assessed approximately 30 and 90 days after the final treatment. Effectiveness is evaluated using investigator-assessed global aesthetic improvement and participant-reported satisfaction, while safety and tolerability are assessed through procedural pain ratings and monitoring of adverse events throughout the study.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Werkelijk)

40

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigde Staten
    • Illinois
      • Naperville, Illinois, Verenigde Staten, 60563
        • Oak Dermatology
    • Maryland
      • Hunt Valley, Maryland, Verenigde Staten, 21030
        • Maryland Dermatology Laser, Skin, & Vein Institute, LLC
    • New Jersey
      • Montclair, New Jersey, Verenigde Staten, 07042
        • New Jersey Plastic Surgery
    • Pennsylvania
      • Devon, Pennsylvania, Verenigde Staten, 19333
        • Laser & Skin Surgery Center of Pennsylvania

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Ja

Beschrijving

Inclusion Criteria:

  • 22 - 70 years old
  • Is willing to undergo study device use.
  • Has not received any toxin/filler in the treatment area in the past 6 months and agrees to not receive any throughout the study.
  • Willing to maintain current diet and exercise routine throughout study duration.
  • Understands and accepts the study condition to not receive any other procedures to the treatment area or to undergo any procedures, take any medications, supplements, or partake in any treatments indicated for weight loss or body contouring throughout the length of the study.
  • Understands and accepts the study condition of and agrees that he or she is able to be present for all study visits.
  • Willing to comply with all requirements of the study and is able to provide written informed consent.

Exclusion Criteria:

  • Is female and pregnant, has been pregnant within the last 3 months, is currently breast feeding, or planning a pregnancy during the study period.
  • Has an implanted pacemaker, internal ventricular fibrillation controller (AICD), or any electrical device.
  • Has a metal implant that interferes with the transmission of energy to the electrical field.
  • Has received permanent fillers or facial implants.
  • Has a detected pathological abnormality.
  • Has a medical condition with potentially decreased function of the peripheral nervous tissue, such as but not limited to diabetes or multiple sclerosis.
  • Has an infection or infected tissue in the treatment area.
  • Unable or not willing to follow instructions for pre- and post-treatment care
  • Recent history of smoking (1 month)
  • Has unrealistic treatment expectations.
  • Has a history of herpes simplex in which the patient is not willing/able to receive preventive antiviral therapy.
  • Has a blood disorder and taking aspirin or blood disorder medications.
  • Has a malignant disease, cancer, or uncontrolled autoimmune disease.
  • Had previous surgical or cosmetic procedures in the treatment area in the last 3 months that could interfere with the treatment procedure (including but not limited to dermabrasion, chemical peels, laser skin resurfacing, fat augmentations, topical retinoids and radiofrequency treatments)
  • Currently enrolled in an investigational drug or device trial, or has received an investigational drug or been treated with an investigational device within the area to be treated 6 months prior to entering this study
  • Has any condition or is in a situation which, in the investigator's opinion, may put the subject at significant risk, may confound study results, or may interfere significantly with the subject's participation.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: XERF Treatment
Apparaat: Noninvasive dual-frequency monopolar radiofrequency
Participants received treatment with a noninvasive contact monopolar radiofrequency (RF) device (XERF) operating at 6.78 MHz and 2.0 MHz. The device delivers RF energy using depth-dependent settings (Shallow, Middle, and Deep) selected based on the target condition and facial anatomic zone. Treatments were performed with the EFFECTOR 60 tip using sliding mode, stamping mode, or a combination, after facial cleansing and application of a thin film of ultrasound gel. Adjustable cryogen gas cooling (ICD Levels 1-3) was used for epidermal protection and comfort; no topical anesthesia was used. Participants underwent two treatment sessions approximately 4 weeks apart (the protocol allowed up to three sessions). The number of shots and total energy delivered (joules) were recorded for each treatment area.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Clinician-Scored Global Aesthetic Improvement Scale (GAIS) Responder Rate
Tijdsspanne: 90 days after the final treatment
Proportion of participants with a GAIS score ≥3 (on a 5-point scale, 1-5), assessed by site principal investigators using standardized clinical photographs. A GAIS score ≥3 was considered an effective clinical improvement.
90 days after the final treatment

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Patient Satisfaction Score (PSS) Responder Rate
Tijdsspanne: 30 and 90 days after the final treatment
Proportion of participants with a Patient Satisfaction Score (PSS) ≥4 on a 6-point scale (1 = extreme dissatisfaction; 6 = significant satisfaction), assessed at follow-up visits.
30 and 90 days after the final treatment
Clinician-Scored Global Aesthetic Improvement Scale (GAIS) Responder Rate at 30 Days
Tijdsspanne: 30 days after the final treatment
Proportion of participants with a GAIS score ≥3 on a 5-point scale (1-5), assessed by site principal investigators using standardized clinical photographs. GAIS ≥3 was considered effective improvement.
30 days after the final treatment
Incidence of Adverse Events
Tijdsspanne: From first treatment through 90 days after the final treatment
Number and proportion of participants experiencing treatment-emergent adverse events, documented throughout the study and follow-up.
From first treatment through 90 days after the final treatment

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

CynosureLutronic

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

20 januari 2025

Primaire voltooiing (Werkelijk)

12 augustus 2025

Studie voltooiing (Werkelijk)

12 augustus 2025

Studieregistratiedata

Eerst ingediend

5 februari 2026

Eerst ingediend dat voldeed aan de QC-criteria

8 mei 2026

Eerst geplaatst (Werkelijk)

14 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

14 mei 2026

Laatste update ingediend die voldeed aan QC-criteria

8 mei 2026

Laatst geverifieerd

1 mei 2026

Meer informatie

Termen gerelateerd aan deze studie

Andere studie-ID-nummers

  • LMP24001

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Ja

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren