ELIXIR MDTM Satisfaction Clinical Trial

NCT07676643 | Active Not Recruiting FDA Device

• 1 other identifier: STUDY00004528
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postoperative Complications; Plastic Surgery

Outcome Measures

Primary Outcomes (1)

• Change in FACE-Q and Body Metrics Questionnaire Score

  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)

Secondary Outcomes (6)

• Mid-term Satisfaction Score (FACE-Q or Body Metrics Questionnaire)

  Postoperative day 30 (POD30)

• Blinded Edema Score on Standardized Photographs

  POD1, 3, 7, 10, and 30

• Percent Bruised Area (Ecchymosis)

  POD1, 3, 7, 10, and 30

• Days from Surgery to Self-Reported Return to Usual Activities

  POD10 and POD30

• Incidence of Device-Related Adverse Events (AEs), Serious Adverse Events (SAEs), and UADEs

  Through postoperative day 30 (POD30)

Study Arms (2)

Active ELIXIR MD PBM

EXPERIMENTAL

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.

Device: Photobiomodulation

Sham/Placebo Control

SHAM COMPARATOR

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.

Device: Photobiomodulation

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.

Active ELIXIR MD PBM; Sham/Placebo Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patient under 18 years of age
• Blepharoplasty (the need for protective eyewear makes it impossible to include this surgery)
• Antecedent of carcinoma, pregnancy, epilepsy, and thyroid conditions
• Antecedent of photosensitive disease such as Lupus, porphyria, xeroderma pigmentosum
• 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)

Sponsors & Collaborators

• Elixir MD Inc: lead
• Cedars-Sinai Medical Center: collaborator

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

MeSH Terms

Conditions

Postoperative Complications

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2026
• First Posted: June 30, 2026
• Study Start: December 9, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: June 30, 2026

Record last verified: 2026-06

Locations

US (1)