NCT03467724

Treatment of Surgical Scars Following Breast Augmentation, Abdominoplasty or Face Lift

Clinical Evaluation of the Safety and Performance of Fractional RF for the Treatment of Surgical Scars Following Breast Augmentation, Abdominoplasty or Face Lift

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Venus Concept · Industry
• Sex: All
• Age: 20 Years – 75 Years
• Healthy volunteers: Accepted

Summary

Evaluator-blinded study of the safety and performance of fractional radiofrequency (FRF) for the treatment of surgical scars following breast augmentation, abdominoplasty or facelift. The study will enroll up to 50 female subjects requesting treatment of surgical scars following breast augmentation or abdominoplasty and up to 25 male and female subjects requesting treatment of surgical scars following facelift surgery. Subjects will receive a total of 3 treatments of their surgical scars at 1-month intervals. Subjects will be followed up at 10 months after their last treatment (12 months after the first treatment).

Conditions

• Surgical Scar
• Breast Augmentation
• Abdominoplasty
• Face Lift

Interventions

Type	Name	Description
DEVICE	Fractional Radiofrequency (FRF)	Fractional radiofrequency will be delivered to the area of the surgical scar.

Timeline

• Start date: 2018-01-23
• Primary completion: 2020-04-13
• Completion: 2020-04-13
• First posted: 2018-03-16
• Last updated: 2024-07-29
• Results posted: 2024-07-29

Locations

1 site across 1 country: Spain