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

NCT03467724 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2024-07-29

Study results available
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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

DEVICE

Fractional Radiofrequency (FRF)

Fractional radiofrequency will be delivered to the area of the surgical scar.

Sponsors & Collaborators

  • Venus Concept

    lead INDUSTRY

Principal Investigators

  • Kai O. Kaye · Ocean Clinic

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-01-23
Primary Completion
2020-04-13
Completion
2020-04-13

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03467724 on ClinicalTrials.gov