Safety and Efficacy Evaluation of the Xerf Device for Aesthetic Treatments

简要摘要

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.