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| Name | Class |
|---|---|
| Cedars-Sinai Medical Center | OTHER |
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This study aims to assess patient satisfaction from the use of the ELIXIR MDâ„¢ photobiomodulation (PBM) device in the perioperative period of facial and body reconstructive surgery at Cedars-Sinai Medical Center. The ELIXIR MDâ„¢ 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 MDâ„¢ 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Photobiomodulation | Device | The ELIXIR MDâ„¢ 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Mid-term Satisfaction Score (FACE-Q or Body Metrics Questionnaire) | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | United States |
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| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D028022 | Low-Level Light Therapy |
| ID | Term |
|---|---|
| D053685 | Laser Therapy |
| D013812 | Therapeutics |
| D010789 | Phototherapy |
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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) | 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 | 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 | 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 | 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 |