Surgical IncisionNCT05897723
Fractional Radiofrequency for Reduction of Surgical Scar Formation
A study testing Fractional Radiofrequency in people with Surgical Incision, run by Venus Concept at 1 site in United States.
Trial summary
Safety and Efficacy of Fractional Radiofrequency for the Reduction of Surgical Scar Formation Read more about this study
- Who is it for?
- Ages 21 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Surgical Incision
- What is being tested?
- Fractional Radiofrequency
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2023to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy, female subjects 21-75 years of age who are seeking pre-treatment for the prevention of surgical scars.
- Able to read, understand and voluntarily provide written Informed Consent.
- Able and willing to comply with the treatment/follow-up schedule and requirements.
- Willing to avoid direct sunlight to the treatment area for the duration of the study.
- 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.
Who cannot join
- Subjects with any implantable metal device in the treatment area
- Pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body (e.g. cochlear implant).
- Permanent implant in the treated area, such as metal plates and screws, or an injected chemical substance.
- Current or history of any kind of cancer, or dysplastic nevi.
- Severe concurrent conditions, such as cardiac disorders.
- Pregnancy or intending to become pregnant during the study and nursing.
Show all 15Show fewer
- Impaired immune system due to immunosuppressive diseases, such as AIDS and HIV, or use of immunosuppressive medications.
- History of diseases stimulated by heat, such as recurrent herpes simplex in the treatment area; may be enrolled only following a prophylactic regime.
- Poorly controlled endocrine disorders, such as diabetes.
- Any active condition in the treatment area, such as sores, psoriasis, eczema, and rash.
- History of skin disorders, such as keloids, abnormal wound healing, as well as very dry and fragile skin.
- History of bleeding coagulopathies, or use of anticoagulants.
- Use of isotretinoin (Accutane®) within six months prior to treatment or at physician discretion.
- Treating over tattoo or permanent makeup.
- Excessively tanned skin from sun, tanning beds or tanning creams within the last two weeks.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
UT Southwestern Medical Center, Department of Plastic Surgery
Dallas, Texas, 75390
Jennifer Barillas, (214) 645-8907 ext. 9132, Jennifer.Barillas@utsouthwestern.edu
About this study
Official title: Safety and Efficacy of Fractional Radiofrequency for the Reduction of Surgical Scar Formation
Safety and Efficacy of Fractional Radiofrequency for the Reduction of Surgical Scar Formation
Read the detailed 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.
- Conditions
- Surgical Incision
- Being tested
- Fractional Radiofrequency
- Medical subject headings
- Surgical Wound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fractional RadiofrequencyDevice
Fractional Radiofrequency (RF) delivering nano-fractional RF energy, causing fractional ablation and coagulation at the treatment site.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | 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. Receives: Device: Fractional Radiofrequency |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 3- and 6-months after treatment
Secondary outcomes (5)
Subject Satisfaction
Subject satisfaction of treatment using the Subject Satisfaction Scale
Measured: 3- and 6-months after treatment
Histological Assessment
Histological assessment of the treated and the untreated (control) area.
Measured: 1-, 3- and 6-months after treatment
Scar Morphology
Scar morphology will be digitally analyzed using 3D photography camera
Measured: Baseline, 3- and 6-months after treatment
Ultrasonography
High ultrasonography will be used to analyze scar thickness, epidermal thickness and skin density
Measured: Baseline, 3- and 6-months after treatment
Colorimetry
- Colorimetry assessment will be used to establish a clinically acceptable objective assessment of patients' scars
Measured: Baseline, 3- and 6-months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2023
- Study start1 Sep 2023
- Primary completion31 May 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical IncisionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Non-randomized, single-center, split-body, evaluator blinded
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Venus Concept
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05897723
- Sponsor's protocol ID
- VI0120
- Status last verified
- Mar 2024
- First submitted
- 1 Jun 2023
- Last updated
- 28 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: No IPD sharing plan.
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Fractional Radiofrequency for the Reduction of Surgical Scar Formation
- ClinicalTrials.gov ID
- NCT05897723
- Acronym / sponsor ID
- VI0120
- Conditions
- Surgical Incision
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Venus ConceptIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 31 May 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 9 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Safety and Efficacy of Fractional Radiofrequency for the Reduction of Surgical Scar Formation
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Non-randomized, single-center, split-body, evaluator blinded
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Device: Fractional RadiofrequencyAll 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. |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Healthy, female subjects 21-75 years of age who are seeking pre-treatment for the prevention of surgical scars.
- Able to read, understand and voluntarily provide written Informed Consent.
- Able and willing to comply with the treatment/follow-up schedule and requirements.
- Willing to avoid direct sunlight to the treatment area for the duration of the study.
- 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.
Key exclusion criteria (15 listed)
- Subjects with any implantable metal device in the treatment area
- Pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body (e.g. cochlear implant).
- Permanent implant in the treated area, such as metal plates and screws, or an injected chemical substance.
- Current or history of any kind of cancer, or dysplastic nevi.
- Severe concurrent conditions, such as cardiac disorders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fractional RadiofrequencyFractional Radiofrequency (RF) delivering nano-fractional RF energy, causing fractional ablation and coagulation at the treatment site. | Device | Treatment Group |
Primary outcome
Independent blinded assessment
Time frame: 6-months after treatment
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.
Principle Investigator (PI) evaluation of the scar(s)
Time frame: 3- and 6-months after treatment
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.
5 secondary outcomes
Subject Satisfaction
Time frame: 3- and 6-months after treatment
Histological Assessment
Time frame: 1-, 3- and 6-months after treatment
Scar Morphology
Time frame: Baseline, 3- and 6-months after treatment
Ultrasonography
Time frame: Baseline, 3- and 6-months after treatment
Colorimetry
Time frame: Baseline, 3- and 6-months after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2025.
- Individual participant dataSharing planned: No. No IPD sharing plan.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fractional Radiofrequency in people with Surgical Incision, run by Venus Concept at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrea Biro, MSc. (8889070115, abiro@venusconcept.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Independent blinded assessment (time frame: 6-months after treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2025.