ELIXIR MDTM Satisfaction Clinical Trial

Part of paid clinical trials in Los Angeles, California.

Sponsor
Elixir MD Inc
Study ID
NCT07676643
Status
Active Not Recruiting

Conditions

  • Plastic Surgery
  • Postoperative Complications

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Photobiomodulation — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Dec 9, 2025
Status verified
Jun 2026
Primary completion
Oct 31, 2026
Completion
Oct 31, 2026

Study Design

Enrollment
148 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: 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.
  • Sham Comparator: 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.

Primary Outcome Measure

Change in FACE-Q and Body Metrics Questionnaire Score [ Time Frame: From baseline (POD0) to postoperative day 10 (POD10) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Cedars-Sinai Medical CenterLos AngelesCalifornia90048-

Find similar trials in Los Angeles, CA

By research site
Cedars-Sinai Medical Center· Los Angeles, CA

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