ELIXIR MDTM Satisfaction Clinical Trial
2026年6月24日 更新者：Elixir MD Inc
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.
研究概览
研究类型
介入性
注册 (估计的)
148
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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California
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Los Angeles、California、美国、90048
- Cedars-Sinai Medical Center
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
是的
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：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.
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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.
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假比较器：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.
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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.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in FACE-Q and Body Metrics Questionnaire Score
大体时间：From baseline (POD0) to postoperative day 10 (POD10)
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Patient-reported satisfaction assessed using FACE-Q (facial surgery) or Body Metrics Questionnaire (body surgery) scores, measured before and after each session
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From baseline (POD0) to postoperative day 10 (POD10)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Mid-term Satisfaction Score (FACE-Q or Body Metrics Questionnaire)
大体时间：Postoperative day 30 (POD30)
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Mid-term patient-reported satisfaction assessed using FACE-Q (facial surgery) or Body Metrics Questionnaire (body surgery) at postoperative day 30
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Postoperative day 30 (POD30)
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Blinded Edema Score on Standardized Photographs
大体时间：POD1, 3, 7, 10, and 30
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Blinded evaluation of edema by independent evaluator using standardized, de-identified photographs assessed at POD1, 3, 7, 10, and 30
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POD1, 3, 7, 10, and 30
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Percent Bruised Area (Ecchymosis)
大体时间：POD1, 3, 7, 10, and 30
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Percent of bruised area evaluated from standardized, de-identified photographs by independent blinded evaluator
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POD1, 3, 7, 10, and 30
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Days from Surgery to Self-Reported Return to Usual Activities
大体时间：POD10 and POD30
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Number of days from surgery date to self-reported resumption of usual daily activities, collected at POD10 and POD30
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POD10 and POD30
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Incidence of Device-Related Adverse Events (AEs), Serious Adverse Events (SAEs), and UADEs
大体时间：Through postoperative day 30 (POD30)
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Incidence and severity of device-related adverse events, serious adverse events, and unanticipated adverse device effects (UADEs) through postoperative day 30
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Through postoperative day 30 (POD30)
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Visual Analog Scale (VAS) Pain Score
大体时间：POD1, 2, 3, 5, 7, 10, and 30
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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)
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POD1, 2, 3, 5, 7, 10, and 30
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2025年12月9日
初级完成 (估计的)
2026年10月1日
研究完成 (估计的)
2026年10月1日
研究注册日期
首次提交
2026年6月24日
首先提交符合 QC 标准的
2026年6月24日
首次发布 (实际的)
2026年6月30日
研究记录更新
最后更新发布 (实际的)
2026年6月30日
上次提交的符合 QC 标准的更新
2026年6月24日
最后验证
2026年6月1日
更多信息
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