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

Breast Ptosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05665335
• Other study ID #: APX-22-03-GR
• Status: Completed
• Phase: N/A
• Start date: November 28, 2022
• Est. completion date: April 26, 2024

Study information

• Verified date: May 2024
• Source: Apyx Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: April 26, 2024
• Est. primary completion date: April 26, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Ptosis

Intervention

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.

Locations

Country	Name	City	State
Greece	Metropolitan General Hospital	Athens

Sponsors (1)

Lead Sponsor	Collaborator
Apyx Medical

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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.	90-Day
Other	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
Other	Change in Breast Ptosis Classification at Day 180	Bilateral analysis of change to Ptosis Classification per the Eyck et al, Rainbow Scale for Assessing Breast Ptosis at baseline and at D180.	180-Day
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	Breast-Q Survey	Subjects will be asked to complete a Breast-Q survey at baseline and Day 180. Subjects will complete the Psychosocial Well-Being and Sexual Well-Being questionnaires. Analysis of change in scores will be assessed between baseline and Day 180.	180-Day
Other	Adverse Events	Analysis of adverse events through the D180.	180-Day
Other	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
Other	Average Reported 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
Other	Average Reported 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
Other	Average Reported 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
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.	180-Day
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.	90-Day