Back to resultsRenuvion APR System When Used as an Adjunct Procedure In Gynecomastia Surgery
Primary Purpose
Gynecomastia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Renuvion APR System
Sponsored by
About this trial
This is an interventional treatment trial for Gynecomastia focused on measuring Renuvion, Helium Plasma
Eligibility Criteria
Inclusion Criteria:
- Male subjects, ages 18 - 75 years old.
- ASA Physical Status Classification System Class I and Class II subjects.
- Clinical diagnosis of primary or secondary Gynecomastia.
- Gynecomastia Rohrich Grade IIA or higher.
- Symmetrical gynecomastia Rohrich grades.
- Symmetrical chest measurements (no more than 3% variance between sides).
- Scheduled for Gynecomastia surgery.
- 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.
- 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.
- 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.
Exclusion Criteria:
- Subjects without clinical diagnosis of primary Gynecomastia and/or a clinical diagnosis of gynecomastia with secondary causes such as medications, drugs, or testicular tumors.
- Subjects presenting with ASA Physical Status Classification System Classes III or higher.
- Gynecomastia Rohrich Grade I.
- Non-symmetrical gynecomastia Rohrich grades.
- Non-symmetrical chest measurements (more than 3% variance between sides).
- Previous treatment or surgery in the breast 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.
- Use of endermology post-procedure for the duration of the study.
- 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.
Sites / Locations
- West End Plastic Surgery
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Bilateral gynecomastia surgery with Renuvion APR System right side
Bilateral gynecomastia surgery with Renuvion APR System left side
Arm Description
The gynecomastia surgery and Renuvion APR System use will be as per investigator's standard clinical practice. The Renuvion APR System will be used on the right side only. The treated side will be randomized and the patient and Independent Reviewer will be blinded as to which side of the chest received Renuvion.
The gynecomastia surgery and Renuvion APR System use will be as per investigator's standard clinical practice. The Renuvion APR System will be used on the left side only. The treated side will be randomized and the patient and Independent Reviewer will be blinded as to which side of the chest received Renuvion.
Outcomes
Primary Outcome Measures
Analysis of bilateral occurrence of adverse events
Analysis of bilateral occurrence of adverse events
Secondary Outcome Measures
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.
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.
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.
Bilateral analysis of skin excised during the procedure by Gynecomastia Grade
Measurement of the amount of skin excised (if any).
Bilateral analysis of gland tissue removal methods during the procedure by Gynecomastia Grade.
Measurement of the amount of gland tissue removed (if any).
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
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
The subject will complete a bilateral Patient Satisfaction Questionnaire
Evaluation of satisfaction for the right side and for the left side.
Baseline images compared to Day 30, 90, and 180 images will be assessed for correct identification of Renuvion-treated side by blinded Independent Photographic Reviewers
Three experienced, blinded photographic reviewers will perform a qualitative analysis/review of pre-treatment and post-treatment sets of images for each subject. Images will be provided in a blinded and randomized order. Each blinded reviewer will choose which side of the chest was treated with Renuvion. Success will be correct identification of treated side of the chest by at least 2 of the 3 reviewers.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05093049
Brief Title
Renuvion APR System When Used as an Adjunct Procedure In Gynecomastia Surgery
Official Title
A Pilot Study of the Renuvion APR System When Used as an Adjunct Procedure In Gynecomastia Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
October 22, 2021 (Actual)
Primary Completion Date
August 17, 2022 (Actual)
Study Completion Date
August 17, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Apyx Medical
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief 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 will be conducted at up to 3 investigational centers in the United States.
Detailed 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 will be conducted at up to 3 investigational centers in the United States.
At baseline, the grade of gynecomastia will be 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 will be as per investigator's standard clinical practice. During the procedure, fat transfer and treatment of the lateral chest and/or axilla is not allowed. The Renuvion APR System will be used on one side only. The treated side will be randomized and the patient will be blinded as to which side of the chest received Renuvion. Procedure data and adverse events will be captured. Endermology is not allowed post-procedure. Post-procedure compression will be used for 2-3 weeks with a standard compression vest for all subjects.
Follow-up images, grade of gynecomastia, and male chest measurements will be taken at D30/D90/D180.
All images will be assessed for correct identification of Renuvion-treated side by blinded Independent Photographic Reviewers (IPR) following the D180 visit.
Following study participation, the subject will be offered an optional balancing treatment to the side not previously treated with Renuvion.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gynecomastia
Keywords
Renuvion, Helium Plasma
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bilateral gynecomastia surgery with Renuvion APR System right side
Arm Type
Active Comparator
Arm Description
The gynecomastia surgery and Renuvion APR System use will be as per investigator's standard clinical practice. The Renuvion APR System will be used on the right side only. The treated side will be randomized and the patient and Independent Reviewer will be blinded as to which side of the chest received Renuvion.
Arm Title
Bilateral gynecomastia surgery with Renuvion APR System left side
Arm Type
Active Comparator
Arm Description
The gynecomastia surgery and Renuvion APR System use will be as per investigator's standard clinical practice. The Renuvion APR System will be used on the left side only. The treated side will be randomized and the patient and Independent Reviewer will be blinded as to which side of the chest received Renuvion.
Intervention Type
Device
Intervention Name(s)
Renuvion APR System
Intervention Description
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.
Primary Outcome Measure Information:
Title
Analysis of bilateral occurrence of adverse events
Description
Analysis of bilateral occurrence of adverse events
Time Frame
Through Day 180
Secondary Outcome Measure Information:
Title
Bilateral analysis of change to Soft-Tissue Pinch Thickness of the Upper Pole
Description
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.
Time Frame
Day 30, 90, 180
Title
Bilateral analysis of change to Soft-Tissue Pinch Thickness at the Inframammary Fold
Description
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.
Time Frame
Day 30, 90, 180
Title
Bilateral analysis of male chest measurements
Description
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.
Time Frame
Day 30, 90, 180
Title
Bilateral analysis of skin excised during the procedure by Gynecomastia Grade
Description
Measurement of the amount of skin excised (if any).
Time Frame
Day 30, 90, 180
Title
Bilateral analysis of gland tissue removal methods during the procedure by Gynecomastia Grade.
Description
Measurement of the amount of gland tissue removed (if any).
Time Frame
Day 30, 90, 180
Title
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
Description
Rating scale: Very Much Improved, Much Improved, Improved, No Change, Worse, Much Worse, Very Much Worse
Time Frame
Day 30, 90, 180
Title
The subject will complete a bilateral Subject Global Aesthetic Improvement Scale assessing overall aesthetic improvement in the treatment area
Description
Rating scale: Very Much Improved, Much Improved, Improved, No Change, Worse, Much Worse, Very Much Worse
Time Frame
Day 30, 90, 180
Title
The subject will complete a bilateral Patient Satisfaction Questionnaire
Description
Evaluation of satisfaction for the right side and for the left side.
Time Frame
Day 30, 90, 180
Title
Baseline images compared to Day 30, 90, and 180 images will be assessed for correct identification of Renuvion-treated side by blinded Independent Photographic Reviewers
Description
Three experienced, blinded photographic reviewers will perform a qualitative analysis/review of pre-treatment and post-treatment sets of images for each subject. Images will be provided in a blinded and randomized order. Each blinded reviewer will choose which side of the chest was treated with Renuvion. Success will be correct identification of treated side of the chest by at least 2 of the 3 reviewers.
Time Frame
Day 30, 90, 180
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Male subjects, ages 18 - 75 years old.
ASA Physical Status Classification System Class I and Class II subjects.
Clinical diagnosis of primary or secondary Gynecomastia.
Gynecomastia Rohrich Grade IIA or higher.
Symmetrical gynecomastia Rohrich grades.
Symmetrical chest measurements (no more than 3% variance between sides).
Scheduled for Gynecomastia surgery.
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.
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.
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.
Exclusion Criteria:
Subjects without clinical diagnosis of primary Gynecomastia and/or a clinical diagnosis of gynecomastia with secondary causes such as medications, drugs, or testicular tumors.
Subjects presenting with ASA Physical Status Classification System Classes III or higher.
Gynecomastia Rohrich Grade I.
Non-symmetrical gynecomastia Rohrich grades.
Non-symmetrical chest measurements (more than 3% variance between sides).
Previous treatment or surgery in the breast 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.
Use of endermology post-procedure for the duration of the study.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul G Ruff, MD
Organizational Affiliation
West End Plastic Surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
West End Plastic Surgery
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Renuvion APR System When Used as an Adjunct Procedure In Gynecomastia Surgery
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