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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fractional radiofrequency (FRF) | Experimental | Subjects received 3 FRF treatments (monthly) over their scar following breast augmentation, abdominoplasty or face lift surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fractional Radiofrequency (FRF) | Device | Fractional radiofrequency will be delivered to the area of the surgical scar. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Improvement of Surgical Scars at 12 Months Compared to Baseline (Pre-treatment) as Evaluated by 3 Independent Blinded Reviewers Using the General Aesthetic Improvement Scale (GAIS). The GAIS Ranges From 3 (Very Much Improved) to -3 (Very Much Worse). | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of Surgical Scars at 12 Months as Evaluated by the Patients. | Patient and Observer Scar Assessment Scale (POSAS) was used to evaluate the scar for pain, itching, color, stiffness, thickness, and appearance compared to their normal skin using a numbered scale. The scale ranges from 7 (no scar) to 70 with higher scores being worse and suggesting a worse scar. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
1. Fitzpatrick skin types 5-6. 2. Implantable defibrillators, cardiac pacemakers, and other metal implants 3. Subjects with any implantable metal device in the treatment area 4. Pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body (e.g. cochlear implant).
5. Permanent implant in the treated area, such as metal plates and screws, or an injected chemical substance.
6. Current or history of any kind of cancer, or pre-malignant moles. 7. Severe concurrent conditions, such as cardiac disorders. 8. Pregnancy or intending to become pregnant during the study and nursing. 9. Impaired immune system due to immunosuppressive diseases, such as AIDS and HIV, or use of immunosuppressive medications.
10. History of diseases stimulated by heat, such as recurrent herpes simplex in the treatment area; may be enrolled only following a prophylactic regime.
11. Poorly controlled endocrine disorders, such as diabetes. 12. Any active condition in the treatment area, such as sores, psoriasis, eczema, and rash.
13. History of skin disorders, such as keloids, abnormal wound healing, as well as very dry and fragile skin.
14. History of bleeding coagulopathies, or use of anticoagulants. 15. Use of isotretinoin (Accutane®) within six months prior to treatment. 16. Treating over tattoo or permanent makeup. 17. Excessively tanned skin from sun, tanning beds or tanning creams within the last two weeks.
18. As per the practitioner's discretion, refrain from treating any condition which might make it unsafe for the patient.
Only female subjects are eligible for surgical scar treatment following breast augmentation and abdominoplasty. Both men and women are eligible for facelift scar treatments.
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| Name | Affiliation | Role |
|---|---|---|
| Kai O. Kaye | Ocean Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ocean Clinic | Marbella | Spain |
3 subjects failed screening and were not treated in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | FRF Treatment | Each subject received 3 VivaMD treatments (monthly). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | FRF Treatment | Each subject received 3 VivaMD treatments (monthly). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Improvement of Surgical Scars at 12 Months Compared to Baseline (Pre-treatment) as Evaluated by 3 Independent Blinded Reviewers Using the General Aesthetic Improvement Scale (GAIS). The GAIS Ranges From 3 (Very Much Improved) to -3 (Very Much Worse). | Posted | Mean | Standard Deviation | units on a scale | 12 months |
|
|
10 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | FRF Treatment | Each subject received 3 VivaMD treatments (monthly). | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Wound Healing Disorder (post-op) | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Affairs | Venus Concept | 1-888-907-0115 | mgronski@venusconcept.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 7, 2018 | Feb 13, 2024 | Prot_SAP_003.pdf |
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The subject will act as their own control. Each surgical scar will be compared at the 12-month follow-up to the pre-treatment baseline.
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The blinded reviewer will review the baseline photographs of the surgical scar(s) and compare them to the photographs taken at follow-up Month 12.
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| Subject Satisfaction With Treatment | Subjects will use the 5-point Likert Satisfaction scale where 4 is very satisfied, 3 is satisfied, 2 is having no opinion, 1 is unsatisfied and 0 is very unsatisfied to evaluate their satisfaction with the treatment. | 12 months |
| Adverse Event |
|
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
|
| Secondary | Assessment of Surgical Scars at 12 Months as Evaluated by the Patients. | Patient and Observer Scar Assessment Scale (POSAS) was used to evaluate the scar for pain, itching, color, stiffness, thickness, and appearance compared to their normal skin using a numbered scale. The scale ranges from 7 (no scar) to 70 with higher scores being worse and suggesting a worse scar. | Posted | Mean | Standard Error | units on a scale | 12 months |
|
|
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| Secondary | Subject Satisfaction With Treatment | Subjects will use the 5-point Likert Satisfaction scale where 4 is very satisfied, 3 is satisfied, 2 is having no opinion, 1 is unsatisfied and 0 is very unsatisfied to evaluate their satisfaction with the treatment. | Posted | Mean | Standard Deviation | units on a scale | 12 months |
|
|
|
| 51 |
| 0 |
| 51 |
| 3 |
| 51 |
| Enlargement of Scar | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
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