An interventional study of Renuvion APR System and Gynecomastia Correction Surgery in Gynecomastia, sponsored by Apyx Medical. Completed at 1 site in United States. Open to male participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-02-08.
Sponsored by Apyx Medical · Not applicable, Interventional, and Treatment
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.
22 studies on the registry are indexed under Gynecomastia; 5 are open to participants now.
This study's enrollment of 10 is below the median of 40 across 13 interventional studies indexed under Gynecomastia.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: Renuvion APR System · Procedure: Gynecomastia Correction Surgery
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.
Procedure: Gynecomastia Correction Surgery
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.
Gynecomastia correction surgery as per the investigators standard treatment of care utilizing liposuction.
Analysis of Bilateral Occurrence of Adverse Events
Analysis of bilateral occurrence of adverse events by study arm.
Time frame: Through Day 180
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.
Time frame: Day 30, 90, 180
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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: Day 180
Patients were recruited from a single site in the United States.
| Milestone | Gynecomastia Surgery Only | Gynecomastia Surgery Followed by Renuvion |
|---|---|---|
| Started | 10 | 10 |
| Completed | 10 | 10 |
| Not completed | 0 | 0 |
Analysis of bilateral occurrence of adverse events by study arm.
| Number of Events | Gynecomastia Surgery Followed by Renuvion | Gynecomastia Surgery Only |
|---|---|---|
| Number of Expected Treatment Effects | 42 | 38 |
| Number of Adverse Events | 6 | 7 |
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.
| cm | Gynecomastia Surgery Followed by Renuvion | Gynecomastia Surgery Only |
|---|---|---|
| Change from Baseline to D30 | -0.29 ± 0.37 | -0.31 ± 0.52 |
| Change from Baseline to D90 | -0.49 ± 0.51 | -0.59 ± 0.51 |
| Change from Baseline to D180 | -0.59 ± 0.53 | -0.72 ± 0.5 |
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.
| cm | Gynecomastia Surgery Followed by Renuvion | Gynecomastia Surgery Only |
|---|---|---|
| Change from Baseline to D30 | -0.11 ± .022 | -0.24 ± 0.29 |
| Change from Baseline to D90 | -0.16 ± 0.27 | -0.28 ± 0.22 |
| Change from Baseline to D180 | -0.17 ± 0.23 | -0.29 ± 0.26 |
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.
| cm | Gynecomastia Surgery Followed by Renuvion | Gynecomastia Surgery Only |
|---|---|---|
| Change in Suprasternal Notch to Nipple from Baseline to D30 | -0.1 (-1.0 to 0.5) | 0 (-0.5 to 0.2) |
| Change in Suprasternal Notch to Nipple from Baseline to D90 | -0.1 (-1.0 to 1.0) | 0 (-1.0 to 0.5) |
| Change in Suprasternal Notch to Nipple from Baseline to D180 | -0.3 (-0.3 to -1.0) | -0.1 (-1.0 to 0.5) |
| Change in Internipple Distance from Baseline to D30 | -0.4 (-2.5 to 1.0) | -0.4 (-2.5 to 1.0) |
| Change in Internipple Distance from Baseline to D90 | -0.7 (-2.5 to 0) | -0.7 (-2.5 to 0) |
| Change in Internipple Distance from Baseline to D180 | -0.8 (-2.0 to 0) | -0.8 (-2.0 to 0) |
| Change in Suprasternal Notch to Nipple Plane from Baseline to D30 | -1.8 (-6.0 to 0.5) | -2.0 (-6.5 to 0.5) |
| Change in Suprasternal Notch to Nipple Plane from Baseline to D90 | -3.5 (-6.5 to -3.5) | -3.5 (-7.0 to 0) |
| Change in Suprasternal Notch to Nipple Plane from Baseline to D180 | -3.4 (-7.0 to -3.4) | -3.5 (-7.5 to -0.5) |
| Change in Midclavicular Point to Nipple from Baseline to D30 | 0.1 (-0.5 to 0.5) | 0 (-1.0 to 0.5) |
| Change in Midclavicular Point to Nipple from Baseline to D90 | 0.2 (-1.0 to 3.0) | 0.3 (-1.5 to 4.5) |
| Change in Midclavicular Point to Nipple from Baseline to D180 | 0.1 (-1.5 to 2.5) | 0.3 (-1.0 to 4.0) |
| Change in Nipple Plane to Umbilicus from Baseline to D30 | -0.4 (-1.5 to 0.5) | -0.4 (-1.5 to 0.5) |
| Change in Nipple Plane to Umbilicus from Baseline to D90 | -0.4 (-2.0 to 1.0) | -0.4 (-2.0 to 1.0) |
| Change in Nipple Plane to Umbilicus from Baseline to D180 | -0.3 (-1.5 to 0.5) | -0.3 (-1.5 to 0.6) |
| Change in Umbilicus to Pubic Symphysis from Baseline to D30 | 0 (0 to 0) | 0 (0 to 0) |
| Change in Umbilicus to Pubic Symphysis from Baseline to D90 | 0 (0 to 0) | 0 (0 to 0) |
| Change in Umbilicus to Pubic Symphysis from Baseline to D180 | 0 (0 to 0) | 0 (0 to 0) |
| Change in Coracoid Process to Nipple Plane from Baseline to D30 | 0.1 (-1.0 to 0.5) | -0.1 (-1.0 to 0.5) |
| Change in Coracoid Process to Nipple Plane from Baseline to D90 | 0.2 (-1.5 to 1.0) | 0.1 (-1.5 to 1.5) |
| Change in Coracoid Process to Nipple Plane from Baseline to D180 | 0.1 (-2.0 to 1.0) | 0.2 (-1.5 to 1.0) |
| Change in Nipple Plane to Medial Epicondyle from Baseline to D30 | -0.1 (-1.0 to 1.0) | -0.1 (-1.3 to 1.0) |
| Change in Nipple Plane to Medial Epicondyle from Baseline to D90 | -0.2 (-1.0 to 1.5) | -0.3 (-1.5 to 1.5) |
| Change in Nipple Plane to Medial Epicondyle from Baseline to D180 | -0.2 (-1.0 to 2.0) | -0.4 (-1.5 to 1.5) |
| Change in Coracoid Process to Medial Epicondyle from Baseline to D30 | 0 (0 to 0) | 0 (0 to 0) |
| Change in Coracoid Process to Medial Epicondyle from Baseline to D90 | 0 (0 to 0) | 0 (0 to 0) |
| Change in Coracoid Process to Medial Epicondyle from Baseline to D180 | 0 (0 to 0) | 0 (0 to 0) |
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
No measurements were reported for this outcome.
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.
| participants | Gynecomastia Surgery Followed by Renuvion | Gynecomastia Surgery Only |
|---|---|---|
| Excision | 2 | 2 |
| No Excision | 8 | 8 |
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
| Participants | Gynecomastia Surgery Followed by Renuvion | Gynecomastia Surgery Only |
|---|---|---|
| D30 — Very Much Improved | 2 | 2 |
| D30 — Much Improved | 5 | 4 |
| D30 — Improved | 2 | 4 |
| D30 — No Change | 1 | 0 |
| D30 — Worse | 0 | 0 |
| D30 — Much Worse | 0 | 0 |
| D30 — Very Much Worse | 0 | 0 |
| D90 — Very Much Improved | 6 | 2 |
| D90 — Much Improved | 2 | 7 |
| D90 — Improved | 2 | 1 |
| D90 — No Change | 0 | 0 |
| D90 — Worse | 0 | 0 |
| D90 — Much Worse | 0 | 0 |
| D90 — Very Much Worse | 0 | 0 |
| D180 — Very Much Improved | 6 | 6 |
| D180 — Much Improved | 4 | 3 |
| D180 — Improved | 0 | 1 |
| D180 — No Change | 0 | 0 |
| D180 — Worse | 0 | 0 |
| D180 — Much Worse | 0 | 0 |
| D180 — Very Much Worse | 0 | 0 |
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
| Participants | Gynecomastia Surgery Followed by Renuvion | Gynecomastia Surgery Only |
|---|---|---|
| D30 — Very Much Improved | 4 | 3 |
| D30 — Much Improved | 4 | 4 |
| D30 — Improved | 2 | 3 |
| D30 — No Change | 0 | 0 |
| D30 — Worse | 0 | 0 |
| D30 — Much Worse | 0 | 0 |
| D30 — Very Much Worse | 0 | 0 |
| D90 — Very Much Improved | 4 | 5 |
| D90 — Much Improved | 5 | 5 |
| D90 — Improved | 1 | 0 |
| D90 — No Change | 0 | 0 |
| D90 — Worse | 0 | 0 |
| D90 — Much Worse | 0 | 0 |
| D90 — Very Much Worse | 0 | 0 |
| D180 — Very Much Improved | 5 | 5 |
| D180 — Much Improved | 3 | 4 |
| D180 — Improved | 2 | 1 |
| D180 — No Change | 0 | 0 |
| D180 — Worse | 0 | 0 |
| D180 — Much Worse | 0 | 0 |
| D180 — Very Much Worse | 0 | 0 |
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.
| Participants | Gynecomastia Surgery Followed by Renuvion | Gynecomastia Surgery Only |
|---|---|---|
| Happy with the results | 9 | 10 |
| Noted more chest definition | 8 | 8 |
| Noted improvement in skin texture in the treatment area | 6 | 5 |
| Noticed a difference in the sides of the chest | 9 | 9 |
| Believed this side side looked better | 3 | 6 |
| Requested a balancing procedure | 7 | 7 |
| Would recommend the procedure to a friend | 9 | 10 |
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.
| Correctly identified side. | All Study Participants |
|---|---|
| Correct Identification of Renuvion-treated Side by Blinded Independent Photographic Reviewers | 5 |
Collected over 180 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Liposuction + Renuvion Side of Chest | 0/10 (0%) | 0/10 (0%) | 4/10 (40%) |
| Liposuction-only Side of the Chest | 0/10 (0%) | 0/10 (0%) | 5/10 (50%) |
| Event | Liposuction + Renuvion Side of Chest | Liposuction-only Side of the Chest |
|---|---|---|
| HeadacheGeneral disorders | 2/10 | 2/10 |
| NauseaGeneral disorders | 2/10 | 2/10 |
| BlisterSkin and subcutaneous tissue disorders | 0/10 | 1/10 |
| Subcutaneous IndurationSkin and subcutaneous tissue disorders | 1/10 | 1/10 |
| Surface ParesthesiaSkin and subcutaneous tissue disorders | 1/10 | 1/10 |
Male subjects were enrolled who needed gynecomastia correction surgery.
| Age, Categorical(Participants) | All Subjects |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 10 |
| >=65 years | 0 |
| Age, Continuous(years) | All Subjects |
|---|---|
| Mean | 41 (19 to 64) |
| Sex: Female, Male(Participants) | All Subjects |
|---|---|
| Female | 0 |
| Male | 10 |
| Race (NIH/OMB)(Participants) | All Subjects |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 3 |
| White | 6 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | All Subjects |
|---|---|
| United States | 10 |
| BMI(kg/m^2) | All Subjects |
|---|---|
| Mean | 26.5 (20.6 to 30.8) |
| Rohrich Classification of Gynecomastia(Participants) | All Subjects |
|---|---|
| Grade IIA | 8 |
| Grade IIB | 2 |
Ran from Oct 2021 to primary completion in Aug 2022, 9 months.
Results were first posted in Feb 2024, 1 year 5 months after primary completion.
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