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ELIXIR MDTM Satisfaction Clinical Trial

24. juni 2026 opdateret af: Elixir MD Inc

Efficacy and Safety of the Photobiomodulation Device ELIXIR in Postoperative Plastic Surgery: A Randomized Clinical Trial

This study aims to assess patient satisfaction from the use of the ELIXIR MD™ photobiomodulation (PBM) device in the perioperative period of facial and body reconstructive surgery at Cedars-Sinai Medical Center. The ELIXIR MD™ device is FDA-cleared (510(k), product code GEX) and delivers low-level, multi-wavelength light energy to targeted tissues to promote cellular repair, reduce inflammation, and enhance patient recovery. Participants undergoing elective facial or body plastic surgery will be randomized 1:1 to receive either active ELIXIR MD™ PBM treatment or sham (placebo) treatment. A total of 8 treatment sessions are scheduled: one preoperative session and sessions on POD 0, 1, 2, 3, 5, 7, and 10, each lasting 20 minutes. A final follow-up visit occurs at POD 30. Patient-reported outcomes (FACE-Q and Body Metrics Questionnaire), blinded edema and ecchymosis assessments via standardized photography, pain scores (VAS), and time to return to usual activities will be evaluated. The study enrolls 148 participants (74 per arm) with equal representation of facial and body surgery patients.

Studieoversigt

Status

Aktiv, ikke rekrutterende

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

148

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • California
      • Los Angeles, California, Forenede Stater, 90048
        • Cedars-Sinai Medical Center

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ja

Beskrivelse

Inclusion Criteria:

  1. Provision of signed and dated informed consent form
  2. Stated willingness to comply with all study procedures and availability for the duration of the study
  3. Male or female, aged > 18 years old
  4. In good general health as evidenced by medical history
  5. Patients presenting to the plastic surgery department at Cedars Sinai for facial or body plastic surgery
  6. Agreement to adhere to Lifestyle Considerations throughout study duration

Exclusion Criteria:

  1. Patient under 18 years of age
  2. Blepharoplasty (the need for protective eyewear makes it impossible to include this surgery)
  3. Antecedent of carcinoma, pregnancy, epilepsy, and thyroid conditions
  4. Antecedent of photosensitive disease such as Lupus, porphyria, xeroderma pigmentosum
  5. Patient taking medications that cause photosensitivity, including: Chlorpromazine (unless not taken within last 8 days), Griseofulvin (unless not taken within last 5 days), Isotretinoin (unless not taken within last 6 months), Tetracyclines (unless not taken within last 5 days), Methotrexate (unless not taken within last 3 days), Amiodarone (at physician's discretion), Hydroquinone (unless not taken within last 2 weeks)

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Active ELIXIR MD PBM
Participants receive active ELIXIR MD photobiomodulation (PBM) treatment using the ELIXIR MD device. Sessions include Detox protocol pre-op, Cellular Repair protocol POD 0-7, and NeoXcell or Roxium protocol at POD 10. Each session is 20 minutes.
Enhed: Photobiomodulation
The ELIXIR MD™ photobiomodulation (PBM) device is an FDA-cleared (510(k), GEX classification) medical-grade light therapy system. It delivers low-level, multi-wavelength light energy (blue 417nm, yellow 590-599nm, red 633nm) to targeted tissues. Three protocols are used: Detox (417nm blue light, pre-op), Cellular Repair (599nm yellow light, POD 0-7), and NeoXcell (633+590nm, POD 10 for light skin types Fitzpatrick I-III) or Roxium (417+590nm, POD 10 for darker skin types Fitzpatrick IV-V). Each session is 20 minutes. Manufactured by Yassen Wellness LLC, regulation 21 CFR 878.4810.
Sham-komparator: Sham/Placebo Control
Participants undergo identical sessions with the ELIXIR MD device with light output disabled. Operational cues (fan, sound, indicator) are mimicked. All participants wear protective eyewear and cannot determine if the device is activated.
Enhed: Photobiomodulation
The ELIXIR MD™ photobiomodulation (PBM) device is an FDA-cleared (510(k), GEX classification) medical-grade light therapy system. It delivers low-level, multi-wavelength light energy (blue 417nm, yellow 590-599nm, red 633nm) to targeted tissues. Three protocols are used: Detox (417nm blue light, pre-op), Cellular Repair (599nm yellow light, POD 0-7), and NeoXcell (633+590nm, POD 10 for light skin types Fitzpatrick I-III) or Roxium (417+590nm, POD 10 for darker skin types Fitzpatrick IV-V). Each session is 20 minutes. Manufactured by Yassen Wellness LLC, regulation 21 CFR 878.4810.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in FACE-Q and Body Metrics Questionnaire Score
Tidsramme: From baseline (POD0) to postoperative day 10 (POD10)
Patient-reported satisfaction assessed using FACE-Q (facial surgery) or Body Metrics Questionnaire (body surgery) scores, measured before and after each session
From baseline (POD0) to postoperative day 10 (POD10)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Mid-term Satisfaction Score (FACE-Q or Body Metrics Questionnaire)
Tidsramme: Postoperative day 30 (POD30)
Mid-term patient-reported satisfaction assessed using FACE-Q (facial surgery) or Body Metrics Questionnaire (body surgery) at postoperative day 30
Postoperative day 30 (POD30)
Blinded Edema Score on Standardized Photographs
Tidsramme: POD1, 3, 7, 10, and 30
Blinded evaluation of edema by independent evaluator using standardized, de-identified photographs assessed at POD1, 3, 7, 10, and 30
POD1, 3, 7, 10, and 30
Percent Bruised Area (Ecchymosis)
Tidsramme: POD1, 3, 7, 10, and 30
Percent of bruised area evaluated from standardized, de-identified photographs by independent blinded evaluator
POD1, 3, 7, 10, and 30
Days from Surgery to Self-Reported Return to Usual Activities
Tidsramme: POD10 and POD30
Number of days from surgery date to self-reported resumption of usual daily activities, collected at POD10 and POD30
POD10 and POD30
Incidence of Device-Related Adverse Events (AEs), Serious Adverse Events (SAEs), and UADEs
Tidsramme: Through postoperative day 30 (POD30)
Incidence and severity of device-related adverse events, serious adverse events, and unanticipated adverse device effects (UADEs) through postoperative day 30
Through postoperative day 30 (POD30)
Visual Analog Scale (VAS) Pain Score
Tidsramme: POD1, 2, 3, 5, 7, 10, and 30
Patient-rated pain on a 0-10 Visual Analog Scale (VAS) after each session and at 1 month (0 = no pain, 10 = worst pain imaginable)
POD1, 2, 3, 5, 7, 10, and 30

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Elixir MD Inc

Samarbejdspartnere

Cedars-Sinai Medical Center

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

9. december 2025

Primær færdiggørelse (Anslået)

1. oktober 2026

Studieafslutning (Anslået)

1. oktober 2026

Datoer for studieregistrering

Først indsendt

24. juni 2026

Først indsendt, der opfyldte QC-kriterier

24. juni 2026

Først opslået (Faktiske)

30. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

30. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

24. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • STUDY00004528

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ja

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