Trial Outcomes & Findings for Renuvion APR System When Used as an Adjunct Procedure In Gynecomastia Surgery (NCT NCT05093049)

NCT ID: NCT05093049

Last Updated: 2024-02-08

Results Overview

Analysis of bilateral occurrence of adverse events by study arm.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 10 participants
• Primary outcome timeframe: Through Day 180
• Results posted on: 2024-02-08

Participant Flow

Patients were recruited from a single site in the 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.

Unit of analysis: Treatment Modality

Participant milestones

Measure	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.	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.
Overall Study STARTED	10 10	10 10
Overall Study COMPLETED	10 10	10 10
Overall Study NOT COMPLETED	0 0	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	All Subjects n=10 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	41 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants
BMI	26.5 kg/m^2 n=5 Participants
Rohrich Classification of Gynecomastia Grade IIA	8 Participants n=5 Participants
Rohrich Classification of Gynecomastia Grade IIB	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: Through Day 180

Population: Healthy, male adult subjects, ages 18 - 75 years old who meet the inclusion/exclusion criteria.

Analysis of bilateral occurrence of adverse events by study arm.

Outcome measures

Measure	Gynecomastia Surgery Followed by Renuvion n=10 Participants 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.	Gynecomastia Surgery Only n=10 Participants Patients receiving gynecomastia correction surgery were randomly assigned to the left or the right side of the chest in a split-body randomized design.
Analysis of Bilateral Occurrence of Adverse Events Number of Expected Treatment Effects	42 Number of Events	38 Number of Events
Analysis of Bilateral Occurrence of Adverse Events Number of Adverse Events	6 Number of Events	7 Number of Events

SECONDARY outcome

Timeframe: Day 30, 90, 180

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.

Outcome measures

Measure	Gynecomastia Surgery Followed by Renuvion n=10 Participants 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.	Gynecomastia Surgery Only n=10 Participants Patients receiving gynecomastia correction surgery were randomly assigned to the left or the right side of the chest in a split-body randomized design.
Bilateral Analysis of Change to Soft-Tissue Pinch Thickness of the Upper Pole Change from Baseline to D30	-0.29 cm Standard Deviation 0.37	-0.31 cm Standard Deviation 0.52
Bilateral Analysis of Change to Soft-Tissue Pinch Thickness of the Upper Pole Change from Baseline to D90	-0.49 cm Standard Deviation 0.51	-0.59 cm Standard Deviation 0.51
Bilateral Analysis of Change to Soft-Tissue Pinch Thickness of the Upper Pole Change from Baseline to D180	-0.59 cm Standard Deviation 0.53	-0.72 cm Standard Deviation 0.5

SECONDARY outcome

Timeframe: Day 30, 90, 180

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.

Outcome measures

Measure	Gynecomastia Surgery Followed by Renuvion n=10 Participants 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.	Gynecomastia Surgery Only n=10 Participants Patients receiving gynecomastia correction surgery were randomly assigned to the left or the right side of the chest in a split-body randomized design.
Bilateral Analysis of Change to Soft-Tissue Pinch Thickness at the Inframammary Fold Change from Baseline to D30	-0.11 cm Standard Deviation .022	-0.24 cm Standard Deviation 0.29
Bilateral Analysis of Change to Soft-Tissue Pinch Thickness at the Inframammary Fold Change from Baseline to D90	-0.16 cm Standard Deviation 0.27	-0.28 cm Standard Deviation 0.22
Bilateral Analysis of Change to Soft-Tissue Pinch Thickness at the Inframammary Fold Change from Baseline to D180	-0.17 cm Standard Deviation 0.23	-0.29 cm Standard Deviation 0.26

SECONDARY outcome

Timeframe: Day 30, 90, 180

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.

Outcome measures

Measure	Gynecomastia Surgery Followed by Renuvion n=10 Participants 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.	Gynecomastia Surgery Only n=10 Participants Patients receiving gynecomastia correction surgery were randomly assigned to the left or the right side of the chest in a split-body randomized design.
Bilateral Analysis of Male Chest Measurements Change in Midclavicular Point to Nipple from Baseline to D30	0.1 cm Interval -0.5 to 0.5	0 cm Interval -1.0 to 0.5
Bilateral Analysis of Male Chest Measurements Change in Nipple Plane to Umbilicus from Baseline to D30	-0.4 cm Interval -1.5 to 0.5	-0.4 cm Interval -1.5 to 0.5
Bilateral Analysis of Male Chest Measurements Change in Nipple Plane to Umbilicus from Baseline to D90	-0.4 cm Interval -2.0 to 1.0	-0.4 cm Interval -2.0 to 1.0
Bilateral Analysis of Male Chest Measurements Change in Coracoid Process to Medial Epicondyle from Baseline to D180	0 cm Interval 0.0 to 0.0	0 cm Interval 0.0 to 0.0
Bilateral Analysis of Male Chest Measurements Change in Suprasternal Notch to Nipple from Baseline to D30	-0.1 cm Interval -1.0 to 0.5	0 cm Interval -0.5 to 0.2
Bilateral Analysis of Male Chest Measurements Change in Suprasternal Notch to Nipple from Baseline to D90	-0.1 cm Interval -1.0 to 1.0	0 cm Interval -1.0 to 0.5
Bilateral Analysis of Male Chest Measurements Change in Suprasternal Notch to Nipple from Baseline to D180	-0.3 cm Interval -0.3 to -1.0	-0.1 cm Interval -1.0 to 0.5
Bilateral Analysis of Male Chest Measurements Change in Internipple Distance from Baseline to D30	-0.4 cm Interval -2.5 to 1.0	-0.4 cm Interval -2.5 to 1.0
Bilateral Analysis of Male Chest Measurements Change in Internipple Distance from Baseline to D90	-0.7 cm Interval -2.5 to 0.0	-0.7 cm Interval -2.5 to 0.0
Bilateral Analysis of Male Chest Measurements Change in Internipple Distance from Baseline to D180	-0.8 cm Interval -2.0 to 0.0	-0.8 cm Interval -2.0 to 0.0
Bilateral Analysis of Male Chest Measurements Change in Suprasternal Notch to Nipple Plane from Baseline to D30	-1.8 cm Interval -6.0 to 0.5	-2.0 cm Interval -6.5 to 0.5
Bilateral Analysis of Male Chest Measurements Change in Suprasternal Notch to Nipple Plane from Baseline to D90	-3.5 cm Interval -6.5 to -3.5	-3.5 cm Interval -7.0 to 0.0
Bilateral Analysis of Male Chest Measurements Change in Suprasternal Notch to Nipple Plane from Baseline to D180	-3.4 cm Interval -7.0 to -3.4	-3.5 cm Interval -7.5 to -0.5
Bilateral Analysis of Male Chest Measurements Change in Midclavicular Point to Nipple from Baseline to D90	0.2 cm Interval -1.0 to 3.0	0.3 cm Interval -1.5 to 4.5
Bilateral Analysis of Male Chest Measurements Change in Midclavicular Point to Nipple from Baseline to D180	0.1 cm Interval -1.5 to 2.5	0.3 cm Interval -1.0 to 4.0
Bilateral Analysis of Male Chest Measurements Change in Nipple Plane to Umbilicus from Baseline to D180	-0.3 cm Interval -1.5 to 0.5	-0.3 cm Interval -1.5 to 0.6
Bilateral Analysis of Male Chest Measurements Change in Umbilicus to Pubic Symphysis from Baseline to D30	0 cm Interval 0.0 to 0.0	0 cm Interval 0.0 to 0.0
Bilateral Analysis of Male Chest Measurements Change in Umbilicus to Pubic Symphysis from Baseline to D90	0 cm Interval 0.0 to 0.0	0 cm Interval 0.0 to 0.0
Bilateral Analysis of Male Chest Measurements Change in Umbilicus to Pubic Symphysis from Baseline to D180	0 cm Interval 0.0 to 0.0	0 cm Interval 0.0 to 0.0
Bilateral Analysis of Male Chest Measurements Change in Coracoid Process to Nipple Plane from Baseline to D30	0.1 cm Interval -1.0 to 0.5	-0.1 cm Interval -1.0 to 0.5
Bilateral Analysis of Male Chest Measurements Change in Coracoid Process to Nipple Plane from Baseline to D90	0.2 cm Interval -1.5 to 1.0	0.1 cm Interval -1.5 to 1.5
Bilateral Analysis of Male Chest Measurements Change in Coracoid Process to Nipple Plane from Baseline to D180	0.1 cm Interval -2.0 to 1.0	0.2 cm Interval -1.5 to 1.0
Bilateral Analysis of Male Chest Measurements Change in Nipple Plane to Medial Epicondyle from Baseline to D30	-0.1 cm Interval -1.0 to 1.0	-0.1 cm Interval -1.3 to 1.0
Bilateral Analysis of Male Chest Measurements Change in Nipple Plane to Medial Epicondyle from Baseline to D90	-0.2 cm Interval -1.0 to 1.5	-0.3 cm Interval -1.5 to 1.5
Bilateral Analysis of Male Chest Measurements Change in Nipple Plane to Medial Epicondyle from Baseline to D180	-0.2 cm Interval -1.0 to 2.0	-0.4 cm Interval -1.5 to 1.5
Bilateral Analysis of Male Chest Measurements Change in Coracoid Process to Medial Epicondyle from Baseline to D30	0 cm Interval 0.0 to 0.0	0 cm Interval 0.0 to 0.0
Bilateral Analysis of Male Chest Measurements Change in Coracoid Process to Medial Epicondyle from Baseline to D90	0 cm Interval 0.0 to 0.0	0 cm Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: Procedure

Population: 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.

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Procedure

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.

Outcome measures

Measure	Gynecomastia Surgery Followed by Renuvion n=10 Participants 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.	Gynecomastia Surgery Only n=10 Participants Patients receiving gynecomastia correction surgery were randomly assigned to the left or the right side of the chest in a split-body randomized design.
Gland Tissue Removal by Number of Participants Excision	2 participants	2 participants
Gland Tissue Removal by Number of Participants No Excision	8 participants	8 participants

SECONDARY outcome

Timeframe: Day 30, 90, 180

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

Outcome measures

Measure	Gynecomastia Surgery Followed by Renuvion n=10 Participants 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.	Gynecomastia Surgery Only n=10 Participants Patients receiving gynecomastia correction surgery were randomly assigned to the left or the right side of the chest in a split-body randomized design.
Bilateral Physician Global Aesthetic Improvement Scale D30 · Very Much Improved	2 Participants	2 Participants
Bilateral Physician Global Aesthetic Improvement Scale D30 · Much Improved	5 Participants	4 Participants
Bilateral Physician Global Aesthetic Improvement Scale D30 · Improved	2 Participants	4 Participants
Bilateral Physician Global Aesthetic Improvement Scale D30 · No Change	1 Participants	0 Participants
Bilateral Physician Global Aesthetic Improvement Scale D30 · Worse	0 Participants	0 Participants
Bilateral Physician Global Aesthetic Improvement Scale D30 · Much Worse	0 Participants	0 Participants
Bilateral Physician Global Aesthetic Improvement Scale D30 · Very Much Worse	0 Participants	0 Participants
Bilateral Physician Global Aesthetic Improvement Scale D90 · Very Much Improved	6 Participants	2 Participants
Bilateral Physician Global Aesthetic Improvement Scale D90 · Much Improved	2 Participants	7 Participants
Bilateral Physician Global Aesthetic Improvement Scale D90 · Improved	2 Participants	1 Participants
Bilateral Physician Global Aesthetic Improvement Scale D90 · No Change	0 Participants	0 Participants
Bilateral Physician Global Aesthetic Improvement Scale D90 · Worse	0 Participants	0 Participants
Bilateral Physician Global Aesthetic Improvement Scale D90 · Much Worse	0 Participants	0 Participants
Bilateral Physician Global Aesthetic Improvement Scale D90 · Very Much Worse	0 Participants	0 Participants
Bilateral Physician Global Aesthetic Improvement Scale D180 · Very Much Improved	6 Participants	6 Participants
Bilateral Physician Global Aesthetic Improvement Scale D180 · Much Improved	4 Participants	3 Participants
Bilateral Physician Global Aesthetic Improvement Scale D180 · Improved	0 Participants	1 Participants
Bilateral Physician Global Aesthetic Improvement Scale D180 · No Change	0 Participants	0 Participants
Bilateral Physician Global Aesthetic Improvement Scale D180 · Worse	0 Participants	0 Participants
Bilateral Physician Global Aesthetic Improvement Scale D180 · Much Worse	0 Participants	0 Participants
Bilateral Physician Global Aesthetic Improvement Scale D180 · Very Much Worse	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Day 30, 90, 180

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

Outcome measures

Measure	Gynecomastia Surgery Followed by Renuvion n=10 Participants 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.	Gynecomastia Surgery Only n=10 Participants Patients receiving gynecomastia correction surgery were randomly assigned to the left or the right side of the chest in a split-body randomized design.
Bilateral Subject Global Aesthetic Improvement Scale D30 · Very Much Improved	4 Participants	3 Participants
Bilateral Subject Global Aesthetic Improvement Scale D30 · Much Improved	4 Participants	4 Participants
Bilateral Subject Global Aesthetic Improvement Scale D30 · Improved	2 Participants	3 Participants
Bilateral Subject Global Aesthetic Improvement Scale D30 · No Change	0 Participants	0 Participants
Bilateral Subject Global Aesthetic Improvement Scale D30 · Worse	0 Participants	0 Participants
Bilateral Subject Global Aesthetic Improvement Scale D30 · Much Worse	0 Participants	0 Participants
Bilateral Subject Global Aesthetic Improvement Scale D30 · Very Much Worse	0 Participants	0 Participants
Bilateral Subject Global Aesthetic Improvement Scale D90 · Very Much Improved	4 Participants	5 Participants
Bilateral Subject Global Aesthetic Improvement Scale D90 · Much Improved	5 Participants	5 Participants
Bilateral Subject Global Aesthetic Improvement Scale D90 · Improved	1 Participants	0 Participants
Bilateral Subject Global Aesthetic Improvement Scale D90 · No Change	0 Participants	0 Participants
Bilateral Subject Global Aesthetic Improvement Scale D90 · Worse	0 Participants	0 Participants
Bilateral Subject Global Aesthetic Improvement Scale D90 · Much Worse	0 Participants	0 Participants
Bilateral Subject Global Aesthetic Improvement Scale D90 · Very Much Worse	0 Participants	0 Participants
Bilateral Subject Global Aesthetic Improvement Scale D180 · Very Much Improved	5 Participants	5 Participants
Bilateral Subject Global Aesthetic Improvement Scale D180 · Much Improved	3 Participants	4 Participants
Bilateral Subject Global Aesthetic Improvement Scale D180 · Improved	2 Participants	1 Participants
Bilateral Subject Global Aesthetic Improvement Scale D180 · No Change	0 Participants	0 Participants
Bilateral Subject Global Aesthetic Improvement Scale D180 · Worse	0 Participants	0 Participants
Bilateral Subject Global Aesthetic Improvement Scale D180 · Much Worse	0 Participants	0 Participants
Bilateral Subject Global Aesthetic Improvement Scale D180 · Very Much Worse	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Day 30, 90, 180

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.

Outcome measures

Measure	Gynecomastia Surgery Followed by Renuvion n=10 Participants 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.	Gynecomastia Surgery Only n=10 Participants Patients receiving gynecomastia correction surgery were randomly assigned to the left or the right side of the chest in a split-body randomized design.
Bilateral Patient Satisfaction Questionnaire Happy with the results	9 Participants	10 Participants
Bilateral Patient Satisfaction Questionnaire Noted more chest definition	8 Participants	8 Participants
Bilateral Patient Satisfaction Questionnaire Noted improvement in skin texture in the treatment area	6 Participants	5 Participants
Bilateral Patient Satisfaction Questionnaire Noticed a difference in the sides of the chest	9 Participants	9 Participants
Bilateral Patient Satisfaction Questionnaire Believed this side side looked better	3 Participants	6 Participants
Bilateral Patient Satisfaction Questionnaire Requested a balancing procedure	7 Participants	7 Participants
Bilateral Patient Satisfaction Questionnaire Would recommend the procedure to a friend	9 Participants	10 Participants

SECONDARY outcome

Timeframe: Day 180

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.

Outcome measures

Measure	Gynecomastia Surgery Followed by Renuvion n=10 Participants 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.	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.
Correct Identification of Renuvion-treated Side by Blinded Independent Photographic Reviewers	5 Correctly identified side.	—

Adverse Events

Liposuction + Renuvion Side of Chest

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Liposuction-only Side of the Chest

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Liposuction + Renuvion Side of Chest n=10 participants at risk 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.	Liposuction-only Side of the Chest n=10 participants at risk 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.
Skin and subcutaneous tissue disorders Blister	0.00% 0/10 • 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.	10.0% 1/10 • Number of events 1 • 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.
Skin and subcutaneous tissue disorders Subcutaneous Induration	10.0% 1/10 • Number of events 1 • 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.	10.0% 1/10 • Number of events 1 • 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.
General disorders Headache	20.0% 2/10 • Number of events 2 • 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.	20.0% 2/10 • Number of events 2 • 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.
General disorders Nausea	20.0% 2/10 • Number of events 2 • 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.	20.0% 2/10 • Number of events 2 • 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.
Skin and subcutaneous tissue disorders Surface Paresthesia	10.0% 1/10 • Number of events 1 • 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.	10.0% 1/10 • Number of events 1 • 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.

Additional Information

Senior Director of Clinical Affairs

Apyx Medical

Phone: 801-244-0058

Email: kari.larson@apyxmedical.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60