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NCT07585591 · ClinicalTrials.gov registry record · NA
Safety and Efficacy Evaluation of the Xerf Device for Aesthetic Treatments
A NA study, sponsored by CynosureLutronic.
- Completed
- Registry status
- NA
- Development phase
- 40
- Enrollment target
NCT07585591: Completed NA study, sponsored by CynosureLutronic.
NCT07585591 is a NA study that has completed, run by CynosureLutronic. The registered enrollment target is 40 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07585591, a NA study, has completed, sponsored by CynosureLutronic.
- COMPLETED
- Registry status
- NA
- Development phase
- 40 participants
- Enrollment target
Study Summary
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.
Primary Outcome
Proportion of participants with a GAIS score ≥3 (on a 5-point scale, 1-5), assessed by site principal investigators using standardized clinical photographs. A GAIS score ≥3 was considered an effective clinical improvement.
Interventions
- DEVICE Noninvasive dual-frequency monopolar radiofrequency
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2025-01-20 |
| Est. Completion | 2025-08-12 |
| Phase | NA |
What the finished NCT07585591 record still lists
NCT07585591 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 1 intervention - of which Noninvasive dual-frequency monopolar radiofrequency is the first listed.
NCT07585591 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07585591 about?
NCT07585591 is a clinical study titled "Safety and Efficacy Evaluation of the Xerf Device for Aesthetic Treatments". 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, s...
What is the current status of trial NCT07585591?
This trial is currently completed. It is a NA study. The enrollment target is 40 participants. The study started on 2025-01-20. Estimated completion is 2025-08-12.
What interventions are being tested in trial NCT07585591?
The interventions under investigation include: Noninvasive dual-frequency monopolar radiofrequency (DEVICE).
Who is sponsoring clinical trial NCT07585591?
This trial is sponsored by CynosureLutronic, which has 9 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07585591's enrollment target sits among peer trials
40 1447th of 2000 higher than 465 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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