A Post-Market Study in Greece of a Minimally Invasive Breast Lift Procedure Utilizing the Renuvion APR System

Study Overview
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Brief Summary
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This is a prospective, non-randomized, single-center, evaluator blinded study of up to 15 subjects undergoing a minimally invasive breast lift procedure utilizing the Renuvion APR System. Subjects will receive treatment with the Renuvion APR System to both breasts.

Detailed Description
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This is a prospective, non-randomized, single-center, evaluator blinded study of up to 15 subjects undergoing a minimally invasive breast lift procedure utilizing the Renuvion APR System. Subjects will receive treatment with the Renuvion APR System to both breasts. At baseline, the grade of breast ptosis, breast measurements and pre-surgery photographs will be taken using the site's camera system. Procedure data and adverse events will be captured. Follow-up visits will occur at 30, 90, and 180-days post-procedure. Subjects may also be seen back for follow-up at the investigator's discretion.

Official Title
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A Post-Market Study of a Minimally Invasive Beast Lift Procedure Utilizing the Renuvion APR System

Conditions
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Breast Ptosis

Intervention / Treatment
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* Device: Renuvion APR System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female subjects, ages 18 - 75 years old. ASA Physical Status Classification System Class I and Class II subjects. Breast Ptosis Class II and Class III as per the Eyck et al, Rainbow Scale for Assessing Breast Ptosis. Breast Cup Size A and Size B. Understands and accepts the obligation not to undergo any other procedures or treatments in the areas to be treated during study participation. Absence of physical conditions unacceptable to the investigator. Females of childbearing potential who are sexually active must be willing to use an approved method of birth control during study participation. Willing and able to comply with protocol requirements, including study-required images/photos, assessments/measurements, and returning for follow-up visits. Willing to release rights for the use of study photos, including in publication. Able to read, understand, sign, and date the informed consent. Able to communicate with the site via video and/or photographs, in the event of a virtual follow-up visit. Exclusion Criteria: Subjects presenting with ASA Physical Status Classification System Classes III or higher. Breast ptosis Class IV or more as per the Eyck et al, Rainbow Scale for Assessing Breast Ptosis. Breast Cup Size C, Size D or larger. Prior surgery or procedure in the breast area (i.e., implants, skin tightening procedures, breast reduction, etc.). Pregnant, lactating, or plans to become pregnant during study participation. Known hypersensitivity or allergy to tumescent anesthetic (lidocaine/ epinephrine). Known hypersensitivity or allergy to ibuprofen or other NSAIDS. Previous treatment in the study treatment area. Active systemic or local skin disease that may alter wound healing. Significant or uncontrolled medical condition that in the opinion of the investigator participation in the study may compromise the patient's health. History of autoimmune disease (excluding Hashimoto's thyroiditis). Known susceptibility to keloid formation or hypertrophic scarring. Cancerous or pre-cancerous lesions in the area to be treated. Possesses a surgically implanted electronic device (i.e., pacemaker). Serious mental health illness such as dementia or schizophrenia; psychiatric hospitalization in the past two years. Participation in any other investigational study within 30 days prior to consent and throughout study participation. Subject who, in the opinion of the investigator, is not an appropriate candidate for the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Renuvion APR System<br>Subjects treated with the Renuvion APR system in both breasts. | Device: Renuvion APR System<br>* The treatment area is defined as superior most not to exceed a horizontal line from the superior aspect of the axilla to the midline; inferior most not to cross the junction of the breast with the abdomen (inframammary fold). Lateral border to the outermost curvature of the breast or a vertical line drawn from the preaxillary line to the IMF; medial most to the innermost curvature of the breast up to 1 cm lateral to the sternal midline. The procedure will be in the intradermal and subdermal planes in the full breast area, without penetrating the breast gland. Renuvion APR System settings will be 60-70% Power, 1.5 LPM, and up to 6 retrograde or 3 antegrade/retrograde passes, with a minimum of 2 incision sites.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Independent Photographic Review of before and after images compared to baseline compared to D180. | Improvement in breast ptosis as determined by a masked, qualitative assessment of photographs at 180-days post-treatment compared to baseline by blinded independent reviewers. | 180-Day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Independent Photographic Review of before and after images compared to baseline at D90. | Improvement in breast ptosis as determined by a masked, qualitative assessment of photographs at 90-days post-treatment compared to baseline by blinded independent reviewers. | 90-Day |