Renuvion APR System When Used as an Adjunct Procedure In Gynecomastia Surgery

Gynecomastia Clinical Trial

Official title:

A Pilot Study of the Renuvion APR System When Used as an Adjunct Procedure In Gynecomastia Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05093049
• Other study ID #: APX-21-02
• Status: Completed
• Phase: N/A
• Start date: October 22, 2021
• Est. completion date: August 17, 2022

Study information

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

Clinical Trial Summary

This is a prospective, multi-center, single-blinded, randomized study of up to 10 study subjects undergoing bilateral gynecomastia surgery with Renuvion APR System used as an adjunct procedure on one side. The study was conducted at a single investigational center in the United States.

Description:

This is a prospective, multi-center, single-blinded, randomized study of up to 10 study subjects undergoing bilateral gynecomastia surgery with Renuvion APR System used as an adjunct procedure on one side. The study was conducted at a single investigational center in the United States.

At baseline, the grade of gynecomastia was recorded by side, male chest measurements will be taken, and pre-surgery photographs taken in the frontal, lateral, and oblique views.

The gynecomastia surgery and Renuvion APR System use were as per investigator's standard clinical practice. During the procedure, fat transfer and treatment of the lateral chest and/or axilla was not allowed. The Renuvion APR System was used on one side only. The Renuvion treated side was randomized and the patient was blinded as to which side of the chest received Renuvion. Procedure data and adverse events were captured. Endermology was not allowed post-procedure. Post-procedure compression was used for 2-3 weeks with a standard compression vest for all subjects.

Follow-up images, grade of gynecomastia, and male chest measurements were taken at D30/D90/D180.

All images were assessed for correct identification of Renuvion-treated side by blinded Independent Photographic Reviewers (IPR) following the D180 visit.

Following study participation, the subject was offered an optional balancing treatment to the side not previously treated with Renuvion.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: August 17, 2022
• Est. primary completion date: August 17, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Male subjects, ages 18 - 75 years old.

2. ASA Physical Status Classification System Class I and Class II subjects.

3. Clinical diagnosis of primary or secondary Gynecomastia.

4. Gynecomastia Rohrich Grade IIA or higher.

5. Symmetrical gynecomastia Rohrich grades.

6. Symmetrical chest measurements (no more than 3% variance between sides).

7. Scheduled for Gynecomastia surgery.

8. Willing to have Renuvion APR System as an adjunct procedure on one side understanding that an optional balancing procedure may be provided post-study exit.

9. Understands and accepts the obligation not to undergo any other procedures or treatments in the areas to be treated during study participation.

10. Absence of physical conditions unacceptable to the investigator.

11. Willing and able to comply with protocol requirements, including study-required images/photos, assessments/measurements, and returning for follow-up visits.

12. Willing to release rights for the use of study photos, including in publication.

13. Able to read, understand, sign, and date the informed consent.

Exclusion Criteria:

1. Subjects without clinical diagnosis of primary Gynecomastia and/or a clinical diagnosis of gynecomastia with secondary causes such as medications, drugs, or testicular tumors.

2. Subjects presenting with ASA Physical Status Classification System Classes III or higher.

3. Gynecomastia Rohrich Grade I.

4. Non-symmetrical gynecomastia Rohrich grades.

5. Non-symmetrical chest measurements (more than 3% variance between sides).

6. Previous treatment or surgery in the breast area.

7. Active systemic or local skin disease that may alter wound healing.

8. Significant or uncontrolled medical condition that in the opinion of the investigator participation in the study may compromise the patient's health.

9. History of autoimmune disease (excluding Hashimoto's thyroiditis).

10. Known susceptibility to keloid formation or hypertrophic scarring.

11. Cancerous or pre-cancerous lesions in the area to be treated.

12. Possesses a surgically implanted electronic device (i.e. pacemaker).

13. Serious mental health illness such as dementia or schizophrenia; psychiatric hospitalization in the past two years.

14. Use of endermology post-procedure for the duration of the study.

15. Participation in any other investigational study within 30 days prior to consent and throughout study participation.

16. Subject who, in the opinion of the investigator, is not an appropriate candidate for the study.

Related Conditions & MeSH terms

• Gynecomastia

Intervention

Device:
• Renuvion APR System
The Renuvion APR Handpiece (K191542) is a sterile, single use electrosurgical (monopolar) device intended to be used in conjunction with compatible generators for the percutaneous delivery of radiofrequency energy and/or helium plasma for cutting, coagulation and ablation of soft tissue. The Renuvion APR Handpiece is compatible with the Electrosurgical Generators BVX-200H/P (K170188), and APYX-JS3/RS3 (K192867) owned by Apyx Medical that are indicated for delivery of radiofrequency energy and/or helium gas plasma to cut, coagulate, and ablate soft tissue during open and laparoscopic surgical procedures.

Procedure:
• Gynecomastia Correction Surgery
Gynecomastia correction surgery as per the investigators standard treatment of care utilizing liposuction.

Locations

Country	Name	City	State
United States	West End Plastic Surgery	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Apyx Medical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Analysis of Bilateral Occurrence of Adverse Events	Analysis of bilateral occurrence of adverse events by study arm.	Through Day 180
Secondary	Bilateral Analysis of Change to Soft-Tissue Pinch Thickness of the Upper Pole	A measurement of the soft-tissue pinch thickness of the upper pole, by isolating skin and subcutaneous tissue superior to the breast parenchyma, pinching firmly, and measuring the thickness with a caliper.	Day 30, 90, 180
Secondary	Bilateral Analysis of Change to Soft-Tissue Pinch Thickness at the Inframammary Fold	A measurement of soft-tissue pinch thickness at the inframammary fold by isolating skin and subcutaneous tissue at the inframammary fold, pinching firmly, and measuring the thickness with a caliper.	Day 30, 90, 180
Secondary	Bilateral Analysis of Male Chest Measurements	Measurement of suprasternal notch to nipple, inter-nipple distance, suprasternal notch to nipple plane, midclavicular point to nipple, nipple plane to umbilicus, umbilicus to pubic symphysis, coracoid process to nipple plane, nipple plane to medial epicondyle, and coracoid process to medial epicondyle.	Day 30, 90, 180
Secondary	Bilateral Analysis of the Amount of Skin Excised During the Procedure by Gynecomastia Grade (Rohrich Classification)	Bilateral measurement of the amount of skin excised during the procedure (if any) by Gynecomastia Grade (Rohrich Classification). Grade I (Minimal hypertrophy, <250g of breast tissue, without ptosis) I A: Primarily glandular* I B: Primarily fibrous* Grade II (Moderate hypertrophy, 250-500g of breast tissue, without ptosis) I A: Primarily glandular* I B: Primarily fibrous* Grade III (Severe hypertrophy, >500g of breast tissue, with grade I ptosis Glandular or fibrous*) Grade IV (Severe hypertrophy with grade I or III ptosis) Glandular or fibrous*; *Fatty and glandular tissue is determined by a pinch test medially, laterally, and beneath the nipple-areola complex	Procedure
Secondary	Gland Tissue Removal by Number of Participants	Bilateral analysis of the number of subjects with gland tissue removed by the during the procedure. The technique utilized for subjects in this study was a mixed surgical technique. The Investigator removed progressive strips of gland in a radial fashion until optimal extraction by palpation was achieved.	Procedure
Secondary	Bilateral Physician Global Aesthetic Improvement Scale	The Principal Investigator, sub-investigator or qualified clinician delegated by the principal investigator, will complete a bilateral Physician Global Aesthetic Improvement Scale assessing overall aesthetic improvement in the treatment area. Rating scale: Very Much Improved, Much Improved, Improved, No Change, Worse, Much Worse, Very Much Worse	Day 30, 90, 180
Secondary	Bilateral Subject Global Aesthetic Improvement Scale	The subject will complete a bilateral Subject Global Aesthetic Improvement Scale assessing overall aesthetic improvement in the treatment area. Rating scale: Very Much Improved, Much Improved, Improved, No Change, Worse, Much Worse, Very Much Worse	Day 30, 90, 180
Secondary	Bilateral Patient Satisfaction Questionnaire	The subject will complete a bilateral Patient Satisfaction Questionnaire for the evaluation of satisfaction for the right side and for the left side. Questions were Yes/No responses.	Day 30, 90, 180
Secondary	Correct Identification of Renuvion-treated Side by Blinded Independent Photographic Reviewers	Three experienced, blinded photographic reviewers performed a qualitative analysis/review of pre-treatment and post-treatment sets of images for each subject. Images were provided in a blinded and randomized order. Each blinded reviewer choose which side of the chest was treated with gynecomastia correction surgery followed by Renuvion treatment. Success was the correct identification of treated side of the chest by at least 2 of the 3 reviewers.	Day 180