NCT05897723

Fractional Radiofrequency for Reduction of Surgical Scar Formation

Safety and Efficacy of Fractional Radiofrequency for the Reduction of Surgical Scar Formation

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Venus Concept · Industry
• Sex: Female
• Age: 21 Years – 75 Years
• Healthy volunteers: Accepted

Summary

Safety and Efficacy of Fractional Radiofrequency for the Reduction of Surgical Scar Formation

Detailed description

The study will evaluate up to 20 subjects scheduled to undergo breast reduction or breast mastectomy in which scar assessment can be made after pre-surgical treatment in a split-body design. The study will involve a single treatment of radiofrequency (RF) applied to one side of the surgical area(s) within 24 hours prior to the procedure. The subject will act as their own control, where one surgical area will be treated, and the other will not be and will act as the control. Tissue samples will be biopsied from the RF treated skin, as well as non-treated skin, at follow up visits. The samples will be used for histological evaluation to assess tissue structure and regeneration following surgery.

Conditions

• Surgical Incision

Interventions

Type	Name	Description
DEVICE	Fractional Radiofrequency	Fractional Radiofrequency (RF) delivering nano-fractional RF energy, causing fractional ablation and coagulation at the treatment site.

Timeline

• Start date: 2023-09-01
• Primary completion: 2025-05-31
• Completion: 2025-12-31
• First posted: 2023-06-09
• Last updated: 2025-03-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study