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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Renuvion APR System | Experimental | Subjects treated with the Renuvion APR system in both breasts. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Renuvion APR System | Device | 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. |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Morphometric Breast Measurements at Day 30 | Bilateral analysis of change to Morphometric breast measurements as per Brown, An Analysis of Ptosis at baseline and at D30. | 30-Day |
| Change in Morphometric Breast Measurements at Day 90 |
Inclusion Criteria:
Exclusion Criteria:
Female subjects
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| Name | Affiliation | Role |
|---|---|---|
| Aris Sterodimas, MD, MSc, PhD | Metropolitan General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Metropolitan General Hospital | Athens | 15562 | Greece |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40236884 | Result | Sterodimas A, Moutafis A, Nicaretta B, Champsas G. A Prospective Study on Helium-Based Plasma Radiofrequency for Minimally Invasive Breast Lift Scarless Mastopexy. Aesthet Surg J Open Forum. 2025 Mar 5;7:ojaf004. doi: 10.1093/asjof/ojaf004. eCollection 2025. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Renuvion APR System | Subjects treated with the Renuvion APR system in both breasts. Renuvion APR System: 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Renuvion APR System | Subjects treated with the Renuvion APR system in both breasts. Renuvion APR System: 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. |
| 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 | 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. | Posted | Count of Participants | Participants | 180-Day |
|
Adverse events and expected treatment effects were evaluated over the 180-day follow-up period.
Adverse events and expected treatment effects (ETEs) were collected.
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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 | Renuvion APR System | Subjects treated with the Renuvion APR system in both breasts. Renuvion APR System: 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kari Larson, Sr. Director of Clinical Affairs | Apyx Medical | 8012440058 | kari.larson@apyxmedical.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 | Sep 23, 2022 | Mar 24, 2025 | Prot_SAP_000.pdf |
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|
Bilateral analysis of change to Morphometric breast measurements as per Brown, An Analysis of Ptosis at baseline and at D90.
| 90-Day |
| Change in Morphometric Breast Measurements at Day 180 | Bilateral analysis of change to Morphometric breast measurements as per Brown, An Analysis of Ptosis at baseline and at D180. | 180-Day |
| Change in Breast Ptosis Classification at Day 180 | Evaluation by the investigator grading the amount of visual breast ptosis (breast laxity) by the Rainbow scale of ptosis includes 5 grades: a Grade I (no ptosis), Grade II (minimal ptosis), Grade III (moderate ptosis), Grade IV (more than moderate ptosis), V (severe ptosis) scale. | 180-Day |
| Investigator Global Aesthetic Improvement Scale (GAIS) at Day 30 | The investigator will grade the overall improvement of treatment area as very much improved, much improved, improved, no change, worse, much worse, or very much worse. | 30-Day |
| Investigator Global Aesthetic Improvement Scale (GAIS) at Day 90 | The investigator will grade the overall improvement of treatment area as very much improved, much improved, improved, no change, worse, much worse, or very much worse. | 90-Day |
| Investigator Global Aesthetic Improvement Scale (GAIS) at Day 180 | The investigator will grade the overall improvement of treatment area as very much improved, much improved, improved, no change, worse, much worse, or very much worse. | 180-Day |
| Subject Global Aesthetic Improvement Scale (GAIS) at Day 30 | The Subject will grade overall improvement of treatment area as very much improved, much improved, improved, no change, worse, much worse, or very much worse. | 30-Day |
| Subject Global Aesthetic Improvement Scale (GAIS) at Day 90 | The Subject will grade overall improvement of treatment area as very much improved, much improved, improved, no change, worse, much worse, or very much worse. | 90-Day |
| Subject Global Aesthetic Improvement Scale (GAIS) at Day 180 | The Subject will grade overall improvement of treatment area as very much improved, much improved, improved, no change, worse, much worse, or very much worse. | 180-Day |
| Patient Satisfaction Questionnaire (PSQ) at Day 180 | Subjects will be asked to complete a satisfaction survey referring to the assessment of baseline photos, current photos, and a mirror. Yes/No - Did you notice any improvement in the laxity or sagginess of your breasts? If yes, checkbox - Less sagging, Breasts look higher on the chest, Nipple placement is improved, Breasts appear more youthful, and/or Other. How would you characterize your satisfaction with the treatment? - very satisfied, satisfied, slightly satisfied, neither satisfied or dissatisfied, slightly dissatisfied, dissatisfied, very dissatisfied. Yes/No - Would you recommend this treatment to your friends and family members? | 180-Day |
| Breast-Q Survey | Subjects will complete the Psychosocial Well-Being and Sexual Well-Being questionnaires. Subjects were instructed "With your breasts in mind, in the past week, how often have you felt:". Responses were 5 options: 1 - None of the time, 2 - A little of the time, 3 - Some of the time, 4 - Most of the time, 5 - All of the time. | 180-Day |
| Average Reported by Subject at Procedure | Study subjects will be asked to complete a 11-point Numeric Rating Scale (NRS) for the level of pain and discomfort associated with the study procedure. Rating Scale where 0 is "No Pain" and 10 is "Worst Possible Pain" | Procedure Day 0 (within 60 minutes following treatment) |
| Average Reported Pain by Subject at Day 30 | Study subjects will be asked to complete a 11-point Numeric Rating Scale (NRS) for the level of pain and discomfort associated with the study procedure. Rating Scale where 0 is "No Pain" and 10 is "Worst Possible Pain" | 30-Day |
| Average Reported Pain by Subject at Day 90 | Study subjects will be asked to complete a 11-point Numeric Rating Scale (NRS) for the level of pain and discomfort associated with the study procedure. Rating Scale where 0 is "No Pain" and 10 is "Worst Possible Pain" | 90-Day |
| Average Reported Pain by Subject at Day 180 | Study subjects will be asked to complete a 11-point Numeric Rating Scale (NRS) for the level of pain and discomfort associated with the study procedure. Rating Scale where 0 is "No Pain" and 10 is "Worst Possible Pain" | 180-Day |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Breast Cup Size | Hemicircumference measured across the maximum projection of the breast from the medial inflection point to the lateral inflection point where the breast creates a crease in the skin when the breast is displaced or pushed medially or laterally. A Cup = 17.0 cm. B Cup = 19.5 cm. C Cup = 21.5 cm. D Cup = 23.5 cm. DD Cup = 25.0 cm. | Count of Participants | Participants |
|
| ASA Status | Evaluation by the investigator determining patient health by the American Society of Anesthesiologists Scale: ASA I = A normal healthy patient ASA II = A patient with mild systemic disease ASA III = A patient with severe systemic disease ASA IV = A patient with severe systemic disease that is a constant threat to life ASA V = A moribund patient who is not expected to survive without the operation ASA VI = A declared brain-dead patient whose organs are being removed for donor purposes. | Count of Participants | Participants |
|
| Rainbow Scale for Breast Ptosis | Evaluation by the investigator grading the amount of visual breast ptosis (breast laxity) by the Rainbow scale of ptosis includes 5 grades: a Grade I (no ptosis), Grade II (minimal ptosis), Grade III (moderate ptosis), Grade IV (more than moderate ptosis), V (severe ptosis) scale. | Count of Participants | Participants |
|
| Breast-Q Survey | Subjects will complete the Psychosocial Well-Being and Sexual Well-Being questionnaires. Subjects were instructed "With your breasts in mind, in the past week, how often have you felt:". Responses were 5 options: 1 - None of the time, 2 - A little of the time, 3 - Some of the time, 4 - Most of the time, 5 - All of the time. | Mean | Standard Deviation | Average units on a scale |
|
| Average Reported Pain by Subject | Study subjects will be asked to complete a 11-point Numeric Rating Scale (NRS) for the level of pain and discomfort associated with the study procedure. Rating Scale where 0 is "No Pain" and 10 is "Worst Possible Pain". | Count of Participants | Participants |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | 90-Day |
|
|
|
| Other Pre-specified | Change in Morphometric Breast Measurements at Day 30 | Bilateral analysis of change to Morphometric breast measurements as per Brown, An Analysis of Ptosis at baseline and at D30. | Posted | Mean | Standard Deviation | cm change from baseline | 30-Day |
|
|
|
| Other Pre-specified | Change in Morphometric Breast Measurements at Day 90 | Bilateral analysis of change to Morphometric breast measurements as per Brown, An Analysis of Ptosis at baseline and at D90. | Posted | Mean | Standard Deviation | cm change from baseline | 90-Day |
|
|
|
| Other Pre-specified | Change in Morphometric Breast Measurements at Day 180 | Bilateral analysis of change to Morphometric breast measurements as per Brown, An Analysis of Ptosis at baseline and at D180. | Posted | Mean | Standard Deviation | cm change from baseline | 180-Day |
|
|
|
| Other Pre-specified | Change in Breast Ptosis Classification at Day 180 | Evaluation by the investigator grading the amount of visual breast ptosis (breast laxity) by the Rainbow scale of ptosis includes 5 grades: a Grade I (no ptosis), Grade II (minimal ptosis), Grade III (moderate ptosis), Grade IV (more than moderate ptosis), V (severe ptosis) scale. | Posted | Count of Participants | Participants | 180-Day |
|
|
|
| Other Pre-specified | Investigator Global Aesthetic Improvement Scale (GAIS) at Day 30 | The investigator will grade the overall improvement of treatment area as very much improved, much improved, improved, no change, worse, much worse, or very much worse. | Posted | Count of Participants | Participants | 30-Day |
|
|
|
| Other Pre-specified | Investigator Global Aesthetic Improvement Scale (GAIS) at Day 90 | The investigator will grade the overall improvement of treatment area as very much improved, much improved, improved, no change, worse, much worse, or very much worse. | Posted | Count of Participants | Participants | 90-Day |
|
|
|
| Other Pre-specified | Investigator Global Aesthetic Improvement Scale (GAIS) at Day 180 | The investigator will grade the overall improvement of treatment area as very much improved, much improved, improved, no change, worse, much worse, or very much worse. | Posted | Count of Participants | Participants | 180-Day |
|
|
|
| Other Pre-specified | Subject Global Aesthetic Improvement Scale (GAIS) at Day 30 | The Subject will grade overall improvement of treatment area as very much improved, much improved, improved, no change, worse, much worse, or very much worse. | Posted | Count of Participants | Participants | 30-Day |
|
|
|
| Other Pre-specified | Subject Global Aesthetic Improvement Scale (GAIS) at Day 90 | The Subject will grade overall improvement of treatment area as very much improved, much improved, improved, no change, worse, much worse, or very much worse. | Posted | Count of Participants | Participants | 90-Day |
|
|
|
| Other Pre-specified | Subject Global Aesthetic Improvement Scale (GAIS) at Day 180 | The Subject will grade overall improvement of treatment area as very much improved, much improved, improved, no change, worse, much worse, or very much worse. | Posted | Count of Participants | Participants | 180-Day |
|
|
|
| Other Pre-specified | Patient Satisfaction Questionnaire (PSQ) at Day 180 | Subjects will be asked to complete a satisfaction survey referring to the assessment of baseline photos, current photos, and a mirror. Yes/No - Did you notice any improvement in the laxity or sagginess of your breasts? If yes, checkbox - Less sagging, Breasts look higher on the chest, Nipple placement is improved, Breasts appear more youthful, and/or Other. How would you characterize your satisfaction with the treatment? - very satisfied, satisfied, slightly satisfied, neither satisfied or dissatisfied, slightly dissatisfied, dissatisfied, very dissatisfied. Yes/No - Would you recommend this treatment to your friends and family members? | Posted | Number | participants | 180-Day |
|
|
|
| Other Pre-specified | Breast-Q Survey | Subjects will complete the Psychosocial Well-Being and Sexual Well-Being questionnaires. Subjects were instructed "With your breasts in mind, in the past week, how often have you felt:". Responses were 5 options: 1 - None of the time, 2 - A little of the time, 3 - Some of the time, 4 - Most of the time, 5 - All of the time. | Posted | Mean | Standard Deviation | average units on a scale | 180-Day |
|
|
|
| Other Pre-specified | Average Reported by Subject at Procedure | Study subjects will be asked to complete a 11-point Numeric Rating Scale (NRS) for the level of pain and discomfort associated with the study procedure. Rating Scale where 0 is "No Pain" and 10 is "Worst Possible Pain" | Posted | Count of Participants | Participants | Procedure Day 0 (within 60 minutes following treatment) |
|
|
|
| Other Pre-specified | Average Reported Pain by Subject at Day 30 | Study subjects will be asked to complete a 11-point Numeric Rating Scale (NRS) for the level of pain and discomfort associated with the study procedure. Rating Scale where 0 is "No Pain" and 10 is "Worst Possible Pain" | Posted | Count of Participants | Participants | 30-Day |
|
|
|
| Other Pre-specified | Average Reported Pain by Subject at Day 90 | Study subjects will be asked to complete a 11-point Numeric Rating Scale (NRS) for the level of pain and discomfort associated with the study procedure. Rating Scale where 0 is "No Pain" and 10 is "Worst Possible Pain" | Posted | Count of Participants | Participants | 90-Day |
|
|
|
| Other Pre-specified | Average Reported Pain by Subject at Day 180 | Study subjects will be asked to complete a 11-point Numeric Rating Scale (NRS) for the level of pain and discomfort associated with the study procedure. Rating Scale where 0 is "No Pain" and 10 is "Worst Possible Pain" | Posted | Count of Participants | Participants | 180-Day |
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
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|
| NAC: nipple-areola complex diameter |
|
| PROJ: maximum point of breast projection measured perpendicular to the chest wall |
|
| N-N: nipple to nipple distance |
|
| SSN-IMC: vertical distance from the suprasternal notch to the inframammary crease |
|
| SSN-base: vertical distance from the suprasternal notch to the lowest point on the base |
|
|
| NAC: nipple-areola complex diameter |
|
| PROJ: maximum point of breast projection measured perpendicular to the chest wall |
|
| N-N: measurements taken at the mid nipple diameter on both sides |
|
| SSN-IMC: vertical distance from the suprasternal notch to the inframammary crease |
|
| SSN-base: vertical distance from the suprasternal notch to the lowest point on the base |
|
|
| NAC: nipple-areola complex diameter |
|
| PROJ: maximum point of breast projection measured perpendicular to the chest wall |
|
| N-N: measurements taken at the mid nipple diameter on both sides |
|
| SSN-IMC: vertical distance from the suprasternal notch to the inframammary crease |
|
| SSN-base: vertical distance from the suprasternal notch to the lowest point on the base |
|
| Grade IV |
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| Grade V |
|
| No Change |
|
| Worse |
|
| Much Worse |
|
| Very Much Worse |
|
| No Change |
|
| Worse |
|
| Much Worse |
|
| Very Much Worse |
|
| No Change |
|
| Worse |
|
| Much Worse |
|
| Very Much Worse |
|
| No Change |
|
| Worse |
|
| Much Worse |
|
| Very Much Worse |
|
| No Change |
|
| Worse |
|
| Much Worse |
|
| Very Much Worse |
|
| No Change |
|
| Worse |
|
| Much Worse |
|
| Very Much Worse |
|
| Title | Measurements |
|---|---|
|
| Yes, Nipple Placement is Improved |
|
| Yes, Breasts Appear More Youthful |
|
| Yes, Would recommend to friends and family |
|
| Title | Measurements |
|---|---|
|
| Of equal worth to other women? |
|
| Attractive? |
|
| Accepting of your body? |
|
| Self-assured? |
|
| Confident about your body? |
|
| Self-confident? |
|
| Sexually attractive in your clothes? |
|
| Comfortable/at ease during sexual activity? |
|
| Confident sexually? |
|
| Sexy when unclothed? |
|
| Confident sexually about how your breasts look when unclothed? |
|
| 3 |
|
| 4 |
|
| 5 |
|
| 6 |
|
| 7 |
|
| 8 |
|
| 9 |
|
| 10 |
|
| 3 |
|
| 4 |
|
| 5 |
|
| 6 |
|
| 7 |
|
| 8 |
|
| 9 |
|
| 10 |
|
| 3 |
|
| 4 |
|
| 5 |
|
| 6 |
|
| 7 |
|
| 8 |
|
| 9 |
|
| 10 |
|
| 3 |
|
| 4 |
|
| 5 |
|
| 6 |
|
| 7 |
|
| 8 |
|
| 9 |
|
| 10 |
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