An interventional study of Fractional Radiofrequency in Surgical Incision, sponsored by Venus Concept. Recruiting at 1 site in United States. Open to female participants aged 21 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-28.
Sponsored by Venus Concept · Not applicable, Interventional, and Treatment
Safety and Efficacy of Fractional Radiofrequency for the Reduction of Surgical Scar Formation
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.
315 studies on the registry are indexed under Surgical Wound; 57 are open to participants now.
This study's planned enrollment of 20 is below the median of 66 across 242 interventional studies indexed under Surgical Wound.
Browse Surgical Wound studies →Venus Concept is the lead sponsor of 34 studies on the registry; 4 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 12 (92%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All enrolled subjects will undergo breast reduction or breast mastectomy in which scar assessment will be made after pre-surgical treatment in a split-body design, involving a single treatment of RF application 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 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.
Device: Fractional Radiofrequency
Fractional Radiofrequency (RF) delivering nano-fractional RF energy, causing fractional ablation and coagulation at the treatment site.
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.
Time frame: 6-months after treatment
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.
Time frame: 3- and 6-months after treatment
Subject Satisfaction
Subject satisfaction of treatment using the Subject Satisfaction Scale
Time frame: 3- and 6-months after treatment
Histological Assessment
Histological assessment of the treated and the untreated (control) area.
Time frame: 1-, 3- and 6-months after treatment
Scar Morphology
Scar morphology will be digitally analyzed using 3D photography camera
Time frame: Baseline, 3- and 6-months after treatment
Ultrasonography
High ultrasonography will be used to analyze scar thickness, epidermal thickness and skin density
Time frame: Baseline, 3- and 6-months after treatment
Colorimetry
o Colorimetry assessment will be used to establish a clinically acceptable objective assessment of patients' scars
Time frame: Baseline, 3- and 6-months after treatment
Plan to share: No — No IPD sharing plan.
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