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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gynecomastia Surgery Followed by Renuvion | Active Comparator | Patients receiving gynecomastia correction surgery followed by Renuvion treatment were randomly assigned to the left or the right side of the chest in a split-body randomized design. The gynecomastia surgery and Renuvion APR System use will be as per investigator's standard clinical practice. |
|
| Gynecomastia Surgery Only | Active Comparator | Patients receiving gynecomastia correction surgery followed by Renuvion treatment were randomly assigned to the left or the right side of the chest in a split-body randomized design. The gynecomastia surgery will be as per investigator's standard clinical practice. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Renuvion APR System | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Analysis of Bilateral Occurrence of Adverse Events | Analysis of bilateral occurrence of adverse events by study arm. | Through Day 180 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Bilateral Analysis of Change to Soft-Tissue Pinch Thickness at the Inframammary Fold |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul G Ruff, MD | West End Plastic Surgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West End Plastic Surgery | Washington D.C. | District of Columbia | 20037 | United States |
All ten subjects in need of gynecomastia correction surgery were treated in a bilateral randomized design. One side of the chest received gynecomastia surgery. The other side received gynecomastia surgery followed by treatment with Renuvion.
Patients were recruited from a single site in the United States.
| ID | Title | Description |
|---|---|---|
| FG000 | Gynecomastia Surgery Only | Patients receiving gynecomastia correction surgery were randomly assigned to the left or the right side of the chest in a split-body randomized design. |
| FG001 | Gynecomastia Surgery Followed by Renuvion | Patients receiving gynecomastia correction surgery followed by Renuvion treatment were randomly assigned to the left or the right side of the chest in a split-body randomized design. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Male subjects were enrolled who needed gynecomastia correction surgery.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Subjects | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Analysis of Bilateral Occurrence of Adverse Events | Analysis of bilateral occurrence of adverse events by study arm. | Healthy, male adult subjects, ages 18 - 75 years old who meet the inclusion/exclusion criteria. | Posted | Number | Number of Events | Through Day 180 |
|
180 days
An expected treatment effect was defined as any typical treatment side-effect of Renuvion APR System of mild to moderate severity and lasting up to a typical maximum duration. An adverse event was defined as any new medical problem, or exacerbation of an existing problem, experienced by a subject while enrolled in the study, whether or not it is considered device-related by the investigator.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Liposuction + Renuvion Side of Chest | The gynecomastia surgery and Renuvion APR System were used as per investigator's standard clinical practice. During the procedure, fat transfer and treatment of the lateral chest and/or axilla were not allowed. The Renuvion APR System was used on one side only. The 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blister | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
Limitations include limited subject numbers, potential variation in subject positioning between visits which can affect measurements, and split body design which due to natural body asymmetry between sides made it challenging to interpret results of the cohorts.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Director of Clinical Affairs | Apyx Medical | 801-244-0058 | kari.larson@apyxmedical.com |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 21, 2021 | Sep 18, 2023 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D006177 | Gynecomastia |
| ID | Term |
|---|---|
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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|
| Gynecomastia Correction Surgery | Procedure | Gynecomastia correction surgery as per the investigators standard treatment of care utilizing liposuction. |
|
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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| BMI | Mean | Full Range | kg/m^2 |
|
| Rohrich Classification of Gynecomastia | 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 | Count of Participants | Participants |
|
|
|
| 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. | Posted | Mean | Standard Deviation | cm | 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. | Posted | Mean | Standard Deviation | cm | 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. | Posted | Mean | Full Range | cm | 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 | None of the patients in this study had skin excised during treatment, thus none were analyzed for this endpoint which was looking at how much skin was excised by their Gynecomastia Grade. In the case of this study, it was none. | Posted | 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. | Posted | Number | participants | 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 | Posted | Count of Participants | Participants | 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 | Posted | Count of Participants | Participants | 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. | Posted | Count of Participants | Participants | 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. | Posted | Number | Correctly identified side. | Day 180 |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 4 |
| 10 |
| EG001 | Liposuction-only Side of the Chest | The gynecomastia surgery and Renuvion APR System were used as per investigator's standard clinical practice. During the procedure, fat transfer and treatment of the lateral chest and/or axilla were not allowed. The Renuvion APR System was used on one side only. The 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. | 0 | 10 | 0 | 10 | 5 | 10 |
| Subcutaneous Induration | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Headache | General disorders | Non-systematic Assessment |
|
| Nausea | General disorders | Non-systematic Assessment |
|
| Surface Paresthesia | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
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| Change from Baseline to D180 |
|
| Change from Baseline to D180 |
|
| Change in Suprasternal Notch to Nipple from Baseline to D180 |
|
| Change in Internipple Distance from Baseline to D30 |
|
| Change in Internipple Distance from Baseline to D90 |
|
| Change in Internipple Distance from Baseline to D180 |
|
| Change in Suprasternal Notch to Nipple Plane from Baseline to D30 |
|
| Change in Suprasternal Notch to Nipple Plane from Baseline to D90 |
|
| Change in Suprasternal Notch to Nipple Plane from Baseline to D180 |
|
| Change in Midclavicular Point to Nipple from Baseline to D30 |
|
| Change in Midclavicular Point to Nipple from Baseline to D90 |
|
| Change in Midclavicular Point to Nipple from Baseline to D180 |
|
| Change in Nipple Plane to Umbilicus from Baseline to D30 |
|
| Change in Nipple Plane to Umbilicus from Baseline to D90 |
|
| Change in Nipple Plane to Umbilicus from Baseline to D180 |
|
| Change in Umbilicus to Pubic Symphysis from Baseline to D30 |
|
| Change in Umbilicus to Pubic Symphysis from Baseline to D90 |
|
| Change in Umbilicus to Pubic Symphysis from Baseline to D180 |
|
| Change in Coracoid Process to Nipple Plane from Baseline to D30 |
|
| Change in Coracoid Process to Nipple Plane from Baseline to D90 |
|
| Change in Coracoid Process to Nipple Plane from Baseline to D180 |
|
| Change in Nipple Plane to Medial Epicondyle from Baseline to D30 |
|
| Change in Nipple Plane to Medial Epicondyle from Baseline to D90 |
|
| Change in Nipple Plane to Medial Epicondyle from Baseline to D180 |
|
| Change in Coracoid Process to Medial Epicondyle from Baseline to D30 |
|
| Change in Coracoid Process to Medial Epicondyle from Baseline to D90 |
|
| Change in Coracoid Process to Medial Epicondyle from Baseline to D180 |
|
| Improved |
|
| No Change |
|
| Worse |
|
| Much Worse |
|
| Very Much Worse |
|
| D90 |
|
| D180 |
|
| Improved |
|
| No Change |
|
| Worse |
|
| Much Worse |
|
| Very Much Worse |
|
| D90 |
|
| D180 |
|
| Noted improvement in skin texture in the treatment area |
|
| Noticed a difference in the sides of the chest |
|
| Believed this side side looked better |
|
| Requested a balancing procedure |
|
| Would recommend the procedure to a friend |
|