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Recruiting NCT05897723

Fractional Radiofrequency for Reduction of Surgical Scar Formation

Trial Parameters

Condition Surgical Incision
Sponsor Venus Concept
Study Type INTERVENTIONAL
Phase N/A
Enrollment 20
Sex FEMALE
Min Age 21 Years
Max Age 75 Years
Start Date 2023-09-01
Completion 2025-05-31
Interventions
Fractional Radiofrequency

Brief Summary

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

Eligibility Criteria

Inclusion Criteria: 1. Healthy, female subjects 21-75 years of age who are seeking pre-treatment for the prevention of surgical scars. 2. Able to read, understand and voluntarily provide written Informed Consent. 3. Able and willing to comply with the treatment/follow-up schedule and requirements. 4. Willing to avoid direct sunlight to the treatment area for the duration of the study. 5. Women of child-bearing age are required to be using a reliable method of birth control at least 3 months prior to study enrollment and for the duration of the study, and have a negative Urine Pregnancy test at baseline. Exclusion Criteria: 1. Subjects with any implantable metal device in the treatment area 2. Pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body (e.g. cochlear implant). 3. Permanent implant in the treated area, such as metal plates and screws, or an injected chemical substance. 4. Current or history of any kind of cancer, or dysplastic nevi. 5

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