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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05897723
Other study ID # VI0120
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 1, 2023
Est. completion date December 2024

Study information

Verified date March 2024
Source Venus Concept
Contact Andrea Biro, MSc.
Phone 8889070115
Email abiro@venusconcept.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date December 2024
Est. primary completion date October 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 21 Years to 75 Years
Eligibility 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. Severe concurrent conditions, such as cardiac disorders. 6. Pregnancy or intending to become pregnant during the study and nursing. 7. Impaired immune system due to immunosuppressive diseases, such as AIDS and HIV, or use of immunosuppressive medications. 8. History of diseases stimulated by heat, such as recurrent herpes simplex in the treatment area; may be enrolled only following a prophylactic regime. 9. Poorly controlled endocrine disorders, such as diabetes. 10. Any active condition in the treatment area, such as sores, psoriasis, eczema, and rash. 11. History of skin disorders, such as keloids, abnormal wound healing, as well as very dry and fragile skin. 12. History of bleeding coagulopathies, or use of anticoagulants. 13. Use of isotretinoin (Accutane®) within six months prior to treatment or at physician discretion. 14. Treating over tattoo or permanent makeup. 15. Excessively tanned skin from sun, tanning beds or tanning creams within the last two weeks.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Fractional Radiofrequency
Fractional Radiofrequency (RF) delivering nano-fractional RF energy, causing fractional ablation and coagulation at the treatment site.

Locations

Country Name City State
United States UT Southwestern Medical Center, Department of Plastic Surgery Dallas Texas

Sponsors (1)

Lead Sponsor Collaborator
Venus Concept

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Independent blinded assessment Independent blinded evaluator assessment of the surgical scar sites using the Global Aesthetic Improvement Scale (GAIS), comparing follow-up visit photographs for both the treated and untreated sides. 6-months after treatment
Primary Principle Investigator (PI) evaluation of the scar(s) PI evaluation of the scar(s) using the Manchester Scar Scale (MSS) at 3 and 6 months post-treatment for both the treated and untreated sides. Non-invasive skin assessments will be evaluated to document scar morphology, scar thickness/density and colorimetry for both the treated and untreated sides. 3- and 6-months after treatment
Secondary Subject Satisfaction Subject satisfaction of treatment using the Subject Satisfaction Scale 3- and 6-months after treatment
Secondary Histological Assessment Histological assessment of the treated and the untreated (control) area. 1-, 3- and 6-months after treatment
Secondary Scar Morphology Scar morphology will be digitally analyzed using 3D photography camera Baseline, 3- and 6-months after treatment
Secondary Ultrasonography High ultrasonography will be used to analyze scar thickness, epidermal thickness and skin density Baseline, 3- and 6-months after treatment
Secondary Colorimetry o Colorimetry assessment will be used to establish a clinically acceptable objective assessment of patients' scars Baseline, 3- and 6-months after treatment
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