GynecomastiaNCT05093049
Renuvion APR System When Used as an Adjunct Procedure In Gynecomastia Surgery
A study testing Renuvion APR System and Gynecomastia Correction Surgery in people with Gynecomastia, run by Apyx Medical at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Gynecomastia
- What is being tested?
- Renuvion APR System and Gynecomastia Correction Surgery
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Oct 2021to 17 Aug 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
West End Plastic Surgery
Washington D.C., District of Columbia, 20037
About this study
Official title: A Pilot Study of the Renuvion APR System When Used as an Adjunct Procedure In Gynecomastia Surgery
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.
Read the 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 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.
- Conditions
- Gynecomastia
- Being tested
- Renuvion APR System, Gynecomastia Correction Surgery
- Keywords
- Renuvion, Helium Plasma
- Medical subject headings
- Gynecomastia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Renuvion APR SystemDevice
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 SurgeryProcedure or surgery
Gynecomastia correction surgery as per the investigators standard treatment of care utilizing liposuction.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Renuvion APR System; Procedure: Gynecomastia Correction Surgery |
| 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. Receives: Procedure: Gynecomastia Correction Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis of Bilateral Occurrence of Adverse Events
Analysis of bilateral occurrence of adverse events by study arm.
Measured: Through Day 180
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: Day 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2021
- Study start22 Oct 2021
- Primary completion17 Aug 2022
- Study completion17 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for GynecomastiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Apyx Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Paul G Ruff, MD, Principal investigator, West End Plastic Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05093049
- Sponsor's protocol ID
- APX-21-02
- Status last verified
- Feb 2024
- First submitted
- 13 Oct 2021
- Last updated
- 8 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of the Renuvion APR System When Used as an Adjunct Procedure In Gynecomastia Surgery
- ClinicalTrials.gov ID
- NCT05093049
- Acronym / sponsor ID
- APX-21-02
- Conditions
- Gynecomastia
- Keywords
- Renuvion, Helium Plasma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Apyx MedicalIndustry (pharma, biotech, devices)
- Study start
- 22 Oct 2021 (actual)
- Primary completion
- 17 Aug 2022 (actual)
- Study completion
- 17 Aug 2022 (actual)
- First posted
- 26 Oct 2021 (actual)
- Results
- Posted 8 Feb 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gynecomastia Surgery Followed by Renuvion | Active comparator | Device: Renuvion APR System, Procedure: Gynecomastia Correction SurgeryPatients 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 | Procedure: Gynecomastia Correction SurgeryPatients 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (16 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Renuvion APR SystemThe 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. | Device | Gynecomastia Surgery Followed by Renuvion |
| Gynecomastia Correction SurgeryGynecomastia correction surgery as per the investigators standard treatment of care utilizing liposuction. | Procedure or surgery | Gynecomastia Surgery Followed by Renuvion, Gynecomastia Surgery Only |
Primary outcome
Analysis of Bilateral Occurrence of Adverse Events
Time frame: Through Day 180
Analysis of bilateral occurrence of adverse events by study arm.
9 secondary outcomes
Bilateral Analysis of Change to Soft-Tissue Pinch Thickness of the Upper Pole
Time frame: Day 30, 90, 180
Bilateral Analysis of Change to Soft-Tissue Pinch Thickness at the Inframammary Fold
Time frame: Day 30, 90, 180
Bilateral Analysis of Male Chest Measurements
Time frame: Day 30, 90, 180
Bilateral Analysis of the Amount of Skin Excised During the Procedure by Gynecomastia Grade (Rohrich Classification)
Time frame: Procedure
Gland Tissue Removal by Number of Participants
Time frame: Procedure
Bilateral Physician Global Aesthetic Improvement Scale
Time frame: Day 30, 90, 180
Bilateral Subject Global Aesthetic Improvement Scale
Time frame: Day 30, 90, 180
Bilateral Patient Satisfaction Questionnaire
Time frame: Day 30, 90, 180
Correct Identification of Renuvion-treated Side by Blinded Independent Photographic Reviewers
Time frame: Day 180
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul G Ruff, MD principal investigator
West End Plastic Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Renuvion APR System and Gynecomastia Correction Surgery in people with Gynecomastia, run by Apyx Medical at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analysis of Bilateral Occurrence of Adverse Events (time frame: Through Day 180). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2024.