Clinical trial NCT05665335: A Post-Market Study in Greece of a Minimally Invasive Breast Lift Procedure Utilizing the Renuvion APR System
Official title: A Post-Market Study of a Minimally Invasive Beast Lift Procedure Utilizing the Renuvion APR System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Ptosis
Lead sponsor: Apyx Medical
Sponsor class: INDUSTRY
First posted: 2022-12-27
Enrollment: 15
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Independent Photographic Review of Before and After Images Compared to Baseline Compared to D180.
timeFrame: 180-Day
Secondary outcomes:
measure: Independent Photographic Review of Before and After Images Compared to Baseline at D90.
timeFrame: 90-Day
Other outcomes:
measure: Change in Morphometric Breast Measurements at Day 30
timeFrame: 30-Day
measure: Change in Morphometric Breast Measurements at Day 90
timeFrame: 90-Day
measure: Change in Morphometric Breast Measurements at Day 180
timeFrame: 180-Day
measure: Change in Breast Ptosis Classification at Day 180
timeFrame: 180-Day
measure: Investigator Global Aesthetic Improvement Scale (GAIS) at Day 30
timeFrame: 30-Day
measure: Investigator Global Aesthetic Improvement Scale (GAIS) at Day 90
timeFrame: 90-Day
measure: Investigator Global Aesthetic Improvement Scale (GAIS) at Day 180
timeFrame: 180-Day
measure: Subject Global Aesthetic Improvement Scale (GAIS) at Day 30
timeFrame: 30-Day
measure: Subject Global Aesthetic Improvement Scale (GAIS) at Day 90
timeFrame: 90-Day
measure: Subject Global Aesthetic Improvement Scale (GAIS) at Day 180
timeFrame: 180-Day
measure: Patient Satisfaction Questionnaire (PSQ) at Day 180
timeFrame: 180-Day
measure: Breast-Q Survey
timeFrame: 180-Day
measure: Average Reported by Subject at Procedure
timeFrame: Procedure Day 0 (within 60 minutes following treatment)
measure: Average Reported Pain by Subject at Day 30
timeFrame: 30-Day
measure: Average Reported Pain by Subject at Day 90
timeFrame: 90-Day
measure: Average Reported Pain by Subject at Day 180
timeFrame: 180-Day
Locations:
city: Athens
country: Greece
facility: Metropolitan General Hospital
Study officials:
affiliation: Metropolitan General Hospital
name: Aris Sterodimas, MD, MSc, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.