ELIXIR MDTM Satisfaction Clinical Trial
NCT: NCT07676643 · ACTIVE_NOT_RECRUITING
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.
Frequently Asked Questions
What is ELIXIR MDTM Satisfaction Clinical Trial?
ELIXIR MDTM Satisfaction Clinical Trial is a clinical trial registered under NCT07676643. Current status: ACTIVE_NOT_RECRUITING.
What is the status of NCT07676643?
The current status of NCT07676643 (ELIXIR MDTM Satisfaction Clinical Trial) is: ACTIVE_NOT_RECRUITING.
When did ELIXIR MDTM Satisfaction Clinical Trial start?
ELIXIR MDTM Satisfaction Clinical Trial started on 2025-12-09.
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Official Source
View on ClinicalTrials.gov →Data sourced from ClinicalTrials.gov API. For the most current status, refer to the official record.