Breast PtosisNCT05665335
A Post-Market Study in Greece of a Minimally Invasive Breast Lift Procedure Utilizing the Renuvion APR System
A study testing Renuvion APR System in people with Breast Ptosis, run by Apyx Medical at 1 site in Greece.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Ptosis
- What is being tested?
- Renuvion APR System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteGreece
- Study dates
- 28 Nov 2022to 26 Apr 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Post-Market Study of a Minimally Invasive Beast Lift Procedure Utilizing the Renuvion APR System
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.
Read the detailed description
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.
- Conditions
- Breast Ptosis
- Being tested
- Renuvion APR System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Renuvion APR SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Renuvion APR System | Experimental | Subjects treated with the Renuvion APR system in both breasts. Receives: Device: Renuvion APR System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 180-Day
Secondary outcomes (1)
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.
Measured: 90-Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2022
- Study start28 Nov 2022
- Primary completion26 Apr 2024
- Study completion26 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast PtosisStudies 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
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Apyx Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Aris Sterodimas, MD, MSc, PhD, Principal investigator, Metropolitan General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05665335
- Sponsor's protocol ID
- APX-22-03-GR
- Status last verified
- Apr 2025
- First submitted
- 16 Dec 2022
- Last updated
- 14 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40236884
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post-Market Study of a Minimally Invasive Beast Lift Procedure Utilizing the Renuvion APR System
- ClinicalTrials.gov ID
- NCT05665335
- Acronym / sponsor ID
- APX-22-03-GR
- Conditions
- Breast Ptosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Apyx MedicalIndustry (pharma, biotech, devices)
- Study start
- 28 Nov 2022 (actual)
- Primary completion
- 26 Apr 2024 (actual)
- Study completion
- 26 Apr 2024 (actual)
- First posted
- 27 Dec 2022 (actual)
- Results
- Posted 14 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Renuvion APR System | Experimental | Device: Renuvion APR SystemSubjects treated with the Renuvion APR system in both breasts. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
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 |
|---|---|---|
| Renuvion APR SystemThe 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. | Device | Renuvion APR System |
Primary outcome
Independent Photographic Review of Before and After Images Compared to Baseline Compared to D180.
Time frame: 180-Day
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.
1 secondary outcome
Independent Photographic Review of Before and After Images Compared to Baseline at D90.
Time frame: 90-Day
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 40236884Sterodimas 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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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.
Aris Sterodimas, MD, MSc, PhD principal investigator
Metropolitan General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Renuvion APR System in people with Breast Ptosis, run by Apyx Medical at 1 site in Greece.
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 11 inclusion and 17 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: finished, as of the sponsor's last update on 14 May 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 Greece. 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?
Yes. Results are posted in the registry (first posted 14 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Independent Photographic Review of Before and After Images Compared to Baseline Compared to D180. (time frame: 180-Day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05665335, which also lists 1 linked publication.
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 14 May 2025.