An interventional study of Renuvion APR System in Breast Ptosis, sponsored by Apyx Medical. Completed at 1 site in Greece. Open to female participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-14.
Sponsored by Apyx Medical · Not applicable, Interventional, and Treatment
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.
Apyx Medical is the lead sponsor of 11 studies on the registry; 1 is open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 8 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
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.
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.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
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.
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.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects treated with the Renuvion APR system in both breasts.
Device: 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.
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.
Time frame: 180-Day
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.
Time frame: 90-Day
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.
Time frame: 30-Day
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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?
Time frame: 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.
Time frame: 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"
Time frame: 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"
Time frame: 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"
Time frame: 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"
Time frame: 180-Day
| Milestone | Renuvion APR System |
|---|---|
| Started | 15 |
| Completed | 15 |
| Not completed | 0 |
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.
| Participants | Renuvion APR System |
|---|---|
| Independent Photographic Review of Before and After Images Compared to Baseline Compared to D180. | 11 |
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.
| Participants | Renuvion APR System |
|---|---|
| Independent Photographic Review of Before and After Images Compared to Baseline at D90. | 10 |
Bilateral analysis of change to Morphometric breast measurements as per Brown, An Analysis of Ptosis at baseline and at D30.
| cm change from baseline | Renuvion APR System |
|---|---|
| SNN-N: Suprasternal notch to nipple distance | -0.7 ± 0.5 |
| IMC-N: Inframammary crease to nipple distance | -0.3 ± 0.5 |
| MCL-N: Midclavicular line to nipple distance | -0.7 ± 0.5 |
| NAC: nipple-areola complex diameter | -0.1 ± 0.4 |
| PROJ: maximum point of breast projection measured perpendicular to the chest wall | -0.2 ± 1.2 |
| N-N: nipple to nipple distance | -0.3 ± 1.0 |
| SSN-IMC: vertical distance from the suprasternal notch to the inframammary crease | -0.5 ± 0.6 |
| SSN-base: vertical distance from the suprasternal notch to the lowest point on the base | -0.9 ± 0.8 |
Bilateral analysis of change to Morphometric breast measurements as per Brown, An Analysis of Ptosis at baseline and at D90.
| cm change from baseline | Renuvion APR System |
|---|---|
| SNN-N: measurements taken at the mid nipple diameter on both sides | -0.9 ± 0.5 |
| IMC-N: measurement taken from the base of the breast to the base of the nipple | -0.6 ± 0.6 |
| MCL-N: measurement taken from the mid clavicle to the mid nipple | -0.8 ± 0.6 |
| NAC: nipple-areola complex diameter | -01. ± 0.5 |
| PROJ: maximum point of breast projection measured perpendicular to the chest wall | 0 ± 1.2 |
| N-N: measurements taken at the mid nipple diameter on both sides | -0.3 ± 1.1 |
| SSN-IMC: vertical distance from the suprasternal notch to the inframammary crease | -0.7 ± 0.8 |
| SSN-base: vertical distance from the suprasternal notch to the lowest point on the base | -1.1 ± 0.8 |
Bilateral analysis of change to Morphometric breast measurements as per Brown, An Analysis of Ptosis at baseline and at D180.
| cm change from baseline | Renuvion APR System |
|---|---|
| SNN-N: measurements taken at the mid nipple diameter on both sides | -1.2 ± 0.7 |
| IMC-N: measurement taken from the base of the breast to the base of the nipple | -0.6 ± 0.5 |
| MCL-N: measurement taken from the mid clavicle to the mid nipple | -0.9 ± 0.7 |
| NAC: nipple-areola complex diameter | 0.1 ± 0.4 |
| PROJ: maximum point of breast projection measured perpendicular to the chest wall | 0.3 ± 1.2 |
| N-N: measurements taken at the mid nipple diameter on both sides | 0 ± 1.1 |
| SSN-IMC: vertical distance from the suprasternal notch to the inframammary crease | -0.8 ± 1.0 |
| SSN-base: vertical distance from the suprasternal notch to the lowest point on the base | -1.5 ± 1.0 |
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.
| Participants | Renuvion APR System |
|---|---|
| Grade I | 6 |
| Grade II | 9 |
| Grade III | 0 |
| Grade IV | 0 |
| Grade V | 0 |
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.
| Participants | Renuvion APR System |
|---|---|
| Very Much Improved | 1 |
| Much Improved | 10 |
| Improved | 4 |
| No Change | 0 |
| Worse | 0 |
| Much Worse | 0 |
| Very Much Worse | 0 |
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.
| Participants | Renuvion APR System |
|---|---|
| Very Much Improved | 4 |
| Much Improved | 9 |
| Improved | 2 |
| No Change | 0 |
| Worse | 0 |
| Much Worse | 0 |
| Very Much Worse | 0 |
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.
| Participants | Renuvion APR System |
|---|---|
| Very Much Improved | 10 |
| Much Improved | 5 |
| Improved | 0 |
| No Change | 0 |
| Worse | 0 |
| Much Worse | 0 |
| Very Much Worse | 0 |
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.
| Participants | Renuvion APR System |
|---|---|
| Very Much Improved | 1 |
| Much Improved | 11 |
| Improved | 3 |
| No Change | 0 |
| Worse | 0 |
| Much Worse | 0 |
| Very Much Worse | 0 |
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.
| Participants | Renuvion APR System |
|---|---|
| Very Much Improved | 4 |
| Much Improved | 8 |
| Improved | 3 |
| No Change | 0 |
| Worse | 0 |
| Much Worse | 0 |
| Very Much Worse | 0 |
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.
| Participants | Renuvion APR System |
|---|---|
| Very Much Improved | 10 |
| Much Improved | 5 |
| Improved | 0 |
| No Change | 0 |
| Worse | 0 |
| Much Worse | 0 |
| Very Much Worse | 0 |
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?
| participants | Renuvion APR System |
|---|---|
| Yes, Improvement Noticed in Breast Area | 15 |
| Yes, Less Sagging Breasts | 15 |
| Yes, Breasts Look Higher on Chest | 15 |
| Yes, Nipple Placement is Improved | 15 |
| Yes, Breasts Appear More Youthful | 15 |
| Yes, Would recommend to friends and family | 15 |
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.
| average units on a scale | Renuvion APR System |
|---|---|
| Confident in a social setting? | 4.3 ± 0.5 |
| Good about yourself? | 4.5 ± 0.5 |
| Confident in your clothes? | 4.5 ± 0.5 |
| Of equal worth to other women? | 4.3 ± 0.5 |
| Attractive? | 4.2 ± 0.6 |
| Accepting of your body? | 4.4 ± 0.6 |
| Self-assured? | 4.4 ± 0.5 |
| Confident about your body? | 4.5 ± 0.5 |
| Self-confident? | 4.7 ± 0.5 |
| Sexually attractive in your clothes? | 4.2 ± 0.6 |
| Comfortable/at ease during sexual activity? | 4.3 ± 0.6 |
| Confident sexually? | 4.3 ± 0.5 |
| Sexy when unclothed? | 4.4 ± 0.6 |
| Confident sexually about how your breasts look when unclothed? | 4.2 ± 0.6 |
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"
| Participants | Renuvion APR System |
|---|---|
| 0 | 15 |
| 1 | 0 |
| 2 | 0 |
| 3 | 0 |
| 4 | 0 |
| 5 | 0 |
| 6 | 0 |
| 7 | 0 |
| 8 | 0 |
| 9 | 0 |
| 10 | 0 |
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"
| Participants | Renuvion APR System |
|---|---|
| 0 | 15 |
| 1 | 0 |
| 2 | 0 |
| 3 | 0 |
| 4 | 0 |
| 5 | 0 |
| 6 | 0 |
| 7 | 0 |
| 8 | 0 |
| 9 | 0 |
| 10 | 0 |
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"
| Participants | Renuvion APR System |
|---|---|
| 0 | 15 |
| 1 | 0 |
| 2 | 0 |
| 3 | 0 |
| 4 | 0 |
| 5 | 0 |
| 6 | 0 |
| 7 | 0 |
| 8 | 0 |
| 9 | 0 |
| 10 | 0 |
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"
| Participants | Renuvion APR System |
|---|---|
| 0 | 15 |
| 1 | 0 |
| 2 | 0 |
| 3 | 0 |
| 4 | 0 |
| 5 | 0 |
| 6 | 0 |
| 7 | 0 |
| 8 | 0 |
| 9 | 0 |
| 10 | 0 |
Collected over Adverse events and expected treatment effects were evaluated over the 180-day follow-up period.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Renuvion APR System | 0/15 (0%) | 0/15 (0%) | 0/15 (0%) |
| Age, Continuous(Years) | Renuvion APR System |
|---|---|
| Mean | 38 ± 9.1 |
| Sex: Female, Male(Participants) | Renuvion APR System |
|---|---|
| Female | 15 |
| Male | 0 |
| Race/Ethnicity, Customized(Participants) | Renuvion APR System |
|---|---|
| Nationality — Greek | 12 |
| Nationality — Albanian | 1 |
| Nationality — Brazilian | 2 |
| Region of Enrollment(participants) | Renuvion APR System |
|---|---|
| Greece | 15 |
| Breast Cup Size(Participants) | Renuvion APR System |
|---|---|
| Cup Size A | 2 |
| Cup Size B | 13 |
| ASA Status(Participants) | Renuvion APR System |
|---|---|
| ASA I | 13 |
| ASA II | 2 |
| Rainbow Scale for Breast Ptosis(Participants) | Renuvion APR System |
|---|---|
| Grade I | 0 |
| Grade II | 15 |
| Grade III | 0 |
| Grade IV | 0 |
| Grade V | 0 |
| Breast-Q Survey(Average units on a scale) | Renuvion APR System |
|---|---|
| Confident in a social setting? | 3.4 ± 0.9 |
| Good about yourself? | 3.6 ± 0.7 |
| Confident in your clothes? | 3.1 ± 0.6 |
| Of equal worth to other women? | 3.2 ± 0.9 |
| Attractive? | 3.2 ± 0.7 |
| Accepting of your body? | 3.2 ± 0.8 |
| Self-assured? | 3.7 ± 0.6 |
| Confident about your body? | 3.0 ± 0.5 |
| Self-confident? | 3.9 ± 0.4 |
| Sexually attractive in your clothes? | 3.1 ± 0.7 |
| Comfortable/at ease during sexual activity? | 3.4 ± 0.8 |
| Confident sexually? | 3.2 ± 0.7 |
| Sexy when unclothed? | 2.5 ± 0.6 |
| Confident sexually about how your breasts look when unclothed? | 2.3 ± 0.5 |
1 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
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