Postoperative ComplicationsNCT07676643
ELIXIR MDTM Satisfaction Clinical Trial
A study testing Photobiomodulation in people with Postoperative Complications and Plastic Surgery, run by Elixir MD Inc at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Postoperative Complications, Plastic Surgery
- What is being tested?
- Photobiomodulation
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 148 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Dec 2025to Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Cedars-Sinai Medical Center
Los Angeles, California, 90048
About this study
Official title: 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.
- Conditions
- Postoperative Complications, Plastic Surgery
- Being tested
- Photobiomodulation
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhotobiomodulationDevice
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Photobiomodulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From baseline (POD0) to postoperative day 10 (POD10)
Secondary outcomes (6)
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
Measured: Postoperative day 30 (POD30)
Blinded Edema Score on Standardized Photographs
Blinded evaluation of edema by independent evaluator using standardized, de-identified photographs assessed at POD1, 3, 7, 10, and 30
Measured: POD1, 3, 7, 10, and 30
Percent Bruised Area (Ecchymosis)
Percent of bruised area evaluated from standardized, de-identified photographs by independent blinded evaluator
Measured: 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
Measured: 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
Measured: 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)
Measured: POD1, 2, 3, 5, 7, 10, and 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2026
- Study start9 Dec 2025
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 148 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Elixir MD Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Cedars-Sinai Medical Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07676643
- Sponsor's protocol ID
- STUDY00004528
- Status last verified
- Jun 2026
- First submitted
- 24 Jun 2026
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of the Photobiomodulation Device ELIXIR in Postoperative Plastic Surgery: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07676643
- Acronym / sponsor ID
- STUDY00004528
- Conditions
- Postoperative Complications, Plastic Surgery
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 148 participants (estimated)
- Lead sponsor
- Elixir MD IncIndustry (pharma, biotech, devices)
- Collaborators
- Cedars-Sinai Medical Center
- Study start
- 9 Dec 2025 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 30 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active ELIXIR MD PBM | Experimental | Device: PhotobiomodulationParticipants 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/Placebo Control | Sham comparator | Device: PhotobiomodulationParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PhotobiomodulationThe 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. | Device | Active ELIXIR MD PBM, Sham/Placebo Control |
Primary outcome
Change in FACE-Q and Body Metrics Questionnaire Score
Time frame: 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
6 secondary outcomes
Mid-term Satisfaction Score (FACE-Q or Body Metrics Questionnaire)
Time frame: Postoperative day 30 (POD30)
Blinded Edema Score on Standardized Photographs
Time frame: POD1, 3, 7, 10, and 30
Percent Bruised Area (Ecchymosis)
Time frame: POD1, 3, 7, 10, and 30
Days from Surgery to Self-Reported Return to Usual Activities
Time frame: POD10 and POD30
Incidence of Device-Related Adverse Events (AEs), Serious Adverse Events (SAEs), and UADEs
Time frame: Through postoperative day 30 (POD30)
Visual Analog Scale (VAS) Pain Score
Time frame: POD1, 2, 3, 5, 7, 10, and 30
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Photobiomodulation in people with Postoperative Complications and Plastic Surgery, run by Elixir MD Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in FACE-Q and Body Metrics Questionnaire Score (time frame: From baseline (POD0) to postoperative day 10 (POD10)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.