Safety and Efficacy Evaluation of the XERF Device for Aesthetic Treatments
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 4
研究概览
简要总结
The goal of this clinical study is to evaluate the safety and clinical effectiveness of the XERF noninvasive dual-frequency monopolar radiofrequency device for aesthetic improvement of facial aging, including fine lines and wrinkles, eyebrow lifting, and tightening of lax tissue in the lower face, submental area, and neck in healthy adults.
Up to 60 participants may be enrolled across up to five clinical sites in the United States. Participants receive XERF treatments using 6.78 MHz and 2.0 MHz energy; most undergo two sessions approximately four weeks apart (the protocol allows up to three). Standardized photographs are taken at baseline and follow-up visits.
Outcomes are assessed approximately 30 and 90 days after the final treatment. Effectiveness is evaluated using investigator-assessed global aesthetic improvement and participant-reported satisfaction, while safety and tolerability are assessed through procedural pain ratings and monitoring of adverse events throughout the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •22 - 70 years old
- •Is willing to undergo study device use.
- •Has not received any toxin/filler in the treatment area in the past 6 months and agrees to not receive any throughout the study.
- •Willing to maintain current diet and exercise routine throughout study duration.
- •Understands and accepts the study condition to not receive any other procedures to the treatment area or to undergo any procedures, take any medications, supplements, or partake in any treatments indicated for weight loss or body contouring throughout the length of the study.
- •Understands and accepts the study condition of and agrees that he or she is able to be present for all study visits.
- •Willing to comply with all requirements of the study and is able to provide written informed consent.
排除标准
- •Is female and pregnant, has been pregnant within the last 3 months, is currently breast feeding, or planning a pregnancy during the study period.
- •Has an implanted pacemaker, internal ventricular fibrillation controller (AICD), or any electrical device.
- •Has a metal implant that interferes with the transmission of energy to the electrical field.
- •Has received permanent fillers or facial implants.
- •Has a detected pathological abnormality.
- •Has a medical condition with potentially decreased function of the peripheral nervous tissue, such as but not limited to diabetes or multiple sclerosis.
- •Has an infection or infected tissue in the treatment area.
- •Unable or not willing to follow instructions for pre- and post-treatment care
- •Recent history of smoking (1 month)
- •Has unrealistic treatment expectations.
- •Has a history of herpes simplex in which the patient is not willing/able to receive preventive antiviral therapy.
- •Has a blood disorder and taking aspirin or blood disorder medications.
- •Has a malignant disease, cancer, or uncontrolled autoimmune disease.
- •Had previous surgical or cosmetic procedures in the treatment area in the last 3 months that could interfere with the treatment procedure (including but not limited to dermabrasion, chemical peels, laser skin resurfacing, fat augmentations, topical retinoids and radiofrequency treatments)
- •Currently enrolled in an investigational drug or device trial, or has received an investigational drug or been treated with an investigational device within the area to be treated 6 months prior to entering this study
- •Has any condition or is in a situation which, in the investigator's opinion, may put the subject at significant risk, may confound study results, or may interfere significantly with the subject's participation.