Trial Outcomes & Findings for A Post-Market Study in Greece of a Minimally Invasive Breast Lift Procedure Utilizing the Renuvion APR System (NCT NCT05665335)
NCT ID: NCT05665335
Last Updated: 2025-05-14
Results Overview
Improvement in breast ptosis as determined by a masked, qualitative assessment of photographs at 180-days post-treatment compared to baseline by blinded independent reviewers.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
15 participants
Primary outcome timeframe
180-Day
Results posted on
2025-05-14
Participant Flow
Participant milestones
| Measure |
Renuvion APR System
Subjects treated with the Renuvion APR system in both breasts.
Renuvion APR System: The treatment area is defined as superior most not to exceed a horizontal line from the superior aspect of the axilla to the midline; inferior most not to cross the junction of the breast with the abdomen (inframammary fold). Lateral border to the outermost curvature of the breast or a vertical line drawn from the preaxillary line to the IMF; medial most to the innermost curvature of the breast up to 1 cm lateral to the sternal midline. The procedure will be in the intradermal and subdermal planes in the full breast area, without penetrating the breast gland.
Renuvion APR System settings will be 60-70% Power, 1.5 LPM, and up to 6 retrograde or 3 antegrade/retrograde passes, with a minimum of 2 incision sites.
|
|---|---|
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Overall Study
STARTED
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15
|
|
Overall Study
COMPLETED
|
15
|
|
Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Post-Market Study in Greece of a Minimally Invasive Breast Lift Procedure Utilizing the Renuvion APR System
Baseline characteristics by cohort
| Measure |
Renuvion APR System
n=15 Participants
Subjects treated with the Renuvion APR system in both breasts.
Renuvion APR System: The treatment area is defined as superior most not to exceed a horizontal line from the superior aspect of the axilla to the midline; inferior most not to cross the junction of the breast with the abdomen (inframammary fold). Lateral border to the outermost curvature of the breast or a vertical line drawn from the preaxillary line to the IMF; medial most to the innermost curvature of the breast up to 1 cm lateral to the sternal midline. The procedure will be in the intradermal and subdermal planes in the full breast area, without penetrating the breast gland.
Renuvion APR System settings will be 60-70% Power, 1.5 LPM, and up to 6 retrograde or 3 antegrade/retrograde passes, with a minimum of 2 incision sites.
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|---|---|
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Age, Continuous
|
38 Years
STANDARD_DEVIATION 9.1 • n=93 Participants
|
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Sex: Female, Male
Female
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15 Participants
n=93 Participants
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Sex: Female, Male
Male
|
0 Participants
n=93 Participants
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|
Race/Ethnicity, Customized
Nationality · Greek
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12 Participants
n=93 Participants
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|
Race/Ethnicity, Customized
Nationality · Albanian
|
1 Participants
n=93 Participants
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|
Race/Ethnicity, Customized
Nationality · Brazilian
|
2 Participants
n=93 Participants
|
|
Region of Enrollment
Greece
|
15 participants
n=93 Participants
|
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Breast Cup Size
Cup Size A
|
2 Participants
n=93 Participants
|
|
Breast Cup Size
Cup Size B
|
13 Participants
n=93 Participants
|
|
ASA Status
ASA I
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13 Participants
n=93 Participants
|
|
ASA Status
ASA II
|
2 Participants
n=93 Participants
|
|
Rainbow Scale for Breast Ptosis
Grade I
|
0 Participants
n=93 Participants
|
|
Rainbow Scale for Breast Ptosis
Grade II
|
15 Participants
n=93 Participants
|
|
Rainbow Scale for Breast Ptosis
Grade III
|
0 Participants
n=93 Participants
|
|
Rainbow Scale for Breast Ptosis
Grade IV
|
0 Participants
n=93 Participants
|
|
Rainbow Scale for Breast Ptosis
Grade V
|
0 Participants
n=93 Participants
|
|
Breast-Q Survey
Confident in a social setting?
|
3.4 Average units on a scale
STANDARD_DEVIATION 0.9 • n=93 Participants
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|
Breast-Q Survey
Good about yourself?
|
3.6 Average units on a scale
STANDARD_DEVIATION 0.7 • n=93 Participants
|
|
Breast-Q Survey
Confident in your clothes?
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3.1 Average units on a scale
STANDARD_DEVIATION 0.6 • n=93 Participants
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|
Breast-Q Survey
Of equal worth to other women?
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3.2 Average units on a scale
STANDARD_DEVIATION 0.9 • n=93 Participants
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|
Breast-Q Survey
Attractive?
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3.2 Average units on a scale
STANDARD_DEVIATION 0.7 • n=93 Participants
|
|
Breast-Q Survey
Accepting of your body?
|
3.2 Average units on a scale
STANDARD_DEVIATION 0.8 • n=93 Participants
|
|
Breast-Q Survey
Self-assured?
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3.7 Average units on a scale
STANDARD_DEVIATION 0.6 • n=93 Participants
|
|
Breast-Q Survey
Confident about your body?
|
3.0 Average units on a scale
STANDARD_DEVIATION 0.5 • n=93 Participants
|
|
Breast-Q Survey
Self-confident?
|
3.9 Average units on a scale
STANDARD_DEVIATION 0.4 • n=93 Participants
|
|
Breast-Q Survey
Sexually attractive in your clothes?
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3.1 Average units on a scale
STANDARD_DEVIATION 0.7 • n=93 Participants
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|
Breast-Q Survey
Comfortable/at ease during sexual activity?
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3.4 Average units on a scale
STANDARD_DEVIATION 0.8 • n=93 Participants
|
|
Breast-Q Survey
Confident sexually?
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3.2 Average units on a scale
STANDARD_DEVIATION 0.7 • n=93 Participants
|
|
Breast-Q Survey
Sexy when unclothed?
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2.5 Average units on a scale
STANDARD_DEVIATION 0.6 • n=93 Participants
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|
Breast-Q Survey
Confident sexually about how your breasts look when unclothed?
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2.3 Average units on a scale
STANDARD_DEVIATION 0.5 • n=93 Participants
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|
Average Reported Pain by Subject
0
|
15 Participants
n=93 Participants
|
|
Average Reported Pain by Subject
1
|
0 Participants
n=93 Participants
|
|
Average Reported Pain by Subject
2
|
0 Participants
n=93 Participants
|
|
Average Reported Pain by Subject
3
|
0 Participants
n=93 Participants
|
|
Average Reported Pain by Subject
4
|
0 Participants
n=93 Participants
|
|
Average Reported Pain by Subject
5
|
0 Participants
n=93 Participants
|
|
Average Reported Pain by Subject
6
|
0 Participants
n=93 Participants
|
|
Average Reported Pain by Subject
7
|
0 Participants
n=93 Participants
|
|
Average Reported Pain by Subject
8
|
0 Participants
n=93 Participants
|
|
Average Reported Pain by Subject
9
|
0 Participants
n=93 Participants
|
|
Average Reported Pain by Subject
10
|
0 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 180-DayImprovement in breast ptosis as determined by a masked, qualitative assessment of photographs at 180-days post-treatment compared to baseline by blinded independent reviewers.
Outcome measures
| Measure |
Renuvion APR System
n=15 Participants
Subjects treated with the Renuvion APR system in both breasts.
Renuvion APR System: The treatment area is defined as superior most not to exceed a horizontal line from the superior aspect of the axilla to the midline; inferior most not to cross the junction of the breast with the abdomen (inframammary fold). Lateral border to the outermost curvature of the breast or a vertical line drawn from the preaxillary line to the IMF; medial most to the innermost curvature of the breast up to 1 cm lateral to the sternal midline. The procedure will be in the intradermal and subdermal planes in the full breast area, without penetrating the breast gland.
Renuvion APR System settings will be 60-70% Power, 1.5 LPM, and up to 6 retrograde or 3 antegrade/retrograde passes, with a minimum of 2 incision sites.
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|---|---|
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Independent Photographic Review of Before and After Images Compared to Baseline Compared to D180.
|
11 Participants
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SECONDARY outcome
Timeframe: 90-DayImprovement in breast ptosis as determined by a masked, qualitative assessment of photographs at 90-days post-treatment compared to baseline by blinded independent reviewers.
Outcome measures
| Measure |
Renuvion APR System
n=15 Participants
Subjects treated with the Renuvion APR system in both breasts.
Renuvion APR System: The treatment area is defined as superior most not to exceed a horizontal line from the superior aspect of the axilla to the midline; inferior most not to cross the junction of the breast with the abdomen (inframammary fold). Lateral border to the outermost curvature of the breast or a vertical line drawn from the preaxillary line to the IMF; medial most to the innermost curvature of the breast up to 1 cm lateral to the sternal midline. The procedure will be in the intradermal and subdermal planes in the full breast area, without penetrating the breast gland.
Renuvion APR System settings will be 60-70% Power, 1.5 LPM, and up to 6 retrograde or 3 antegrade/retrograde passes, with a minimum of 2 incision sites.
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|---|---|
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Independent Photographic Review of Before and After Images Compared to Baseline at D90.
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10 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 30-DayBilateral analysis of change to Morphometric breast measurements as per Brown, An Analysis of Ptosis at baseline and at D30.
Outcome measures
| Measure |
Renuvion APR System
n=15 Participants
Subjects treated with the Renuvion APR system in both breasts.
Renuvion APR System: The treatment area is defined as superior most not to exceed a horizontal line from the superior aspect of the axilla to the midline; inferior most not to cross the junction of the breast with the abdomen (inframammary fold). Lateral border to the outermost curvature of the breast or a vertical line drawn from the preaxillary line to the IMF; medial most to the innermost curvature of the breast up to 1 cm lateral to the sternal midline. The procedure will be in the intradermal and subdermal planes in the full breast area, without penetrating the breast gland.
Renuvion APR System settings will be 60-70% Power, 1.5 LPM, and up to 6 retrograde or 3 antegrade/retrograde passes, with a minimum of 2 incision sites.
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|---|---|
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Change in Morphometric Breast Measurements at Day 30
SNN-N: Suprasternal notch to nipple distance
|
-0.7 cm change from baseline
Standard Deviation 0.5
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Change in Morphometric Breast Measurements at Day 30
IMC-N: Inframammary crease to nipple distance
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-0.3 cm change from baseline
Standard Deviation 0.5
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|
Change in Morphometric Breast Measurements at Day 30
MCL-N: Midclavicular line to nipple distance
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-0.7 cm change from baseline
Standard Deviation 0.5
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Change in Morphometric Breast Measurements at Day 30
NAC: nipple-areola complex diameter
|
-0.1 cm change from baseline
Standard Deviation 0.4
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|
Change in Morphometric Breast Measurements at Day 30
PROJ: maximum point of breast projection measured perpendicular to the chest wall
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-0.2 cm change from baseline
Standard Deviation 1.2
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Change in Morphometric Breast Measurements at Day 30
N-N: nipple to nipple distance
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-0.3 cm change from baseline
Standard Deviation 1.0
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|
Change in Morphometric Breast Measurements at Day 30
SSN-IMC: vertical distance from the suprasternal notch to the inframammary crease
|
-0.5 cm change from baseline
Standard Deviation 0.6
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Change in Morphometric Breast Measurements at Day 30
SSN-base: vertical distance from the suprasternal notch to the lowest point on the base
|
-0.9 cm change from baseline
Standard Deviation 0.8
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OTHER_PRE_SPECIFIED outcome
Timeframe: 90-DayBilateral analysis of change to Morphometric breast measurements as per Brown, An Analysis of Ptosis at baseline and at D90.
Outcome measures
| Measure |
Renuvion APR System
n=15 Participants
Subjects treated with the Renuvion APR system in both breasts.
Renuvion APR System: The treatment area is defined as superior most not to exceed a horizontal line from the superior aspect of the axilla to the midline; inferior most not to cross the junction of the breast with the abdomen (inframammary fold). Lateral border to the outermost curvature of the breast or a vertical line drawn from the preaxillary line to the IMF; medial most to the innermost curvature of the breast up to 1 cm lateral to the sternal midline. The procedure will be in the intradermal and subdermal planes in the full breast area, without penetrating the breast gland.
Renuvion APR System settings will be 60-70% Power, 1.5 LPM, and up to 6 retrograde or 3 antegrade/retrograde passes, with a minimum of 2 incision sites.
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|---|---|
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Change in Morphometric Breast Measurements at Day 90
SNN-N: measurements taken at the mid nipple diameter on both sides
|
-0.9 cm change from baseline
Standard Deviation 0.5
|
|
Change in Morphometric Breast Measurements at Day 90
IMC-N: measurement taken from the base of the breast to the base of the nipple
|
-0.6 cm change from baseline
Standard Deviation 0.6
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|
Change in Morphometric Breast Measurements at Day 90
MCL-N: measurement taken from the mid clavicle to the mid nipple
|
-0.8 cm change from baseline
Standard Deviation 0.6
|
|
Change in Morphometric Breast Measurements at Day 90
NAC: nipple-areola complex diameter
|
-01. cm change from baseline
Standard Deviation 0.5
|
|
Change in Morphometric Breast Measurements at Day 90
PROJ: maximum point of breast projection measured perpendicular to the chest wall
|
0 cm change from baseline
Standard Deviation 1.2
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|
Change in Morphometric Breast Measurements at Day 90
N-N: measurements taken at the mid nipple diameter on both sides
|
-0.3 cm change from baseline
Standard Deviation 1.1
|
|
Change in Morphometric Breast Measurements at Day 90
SSN-IMC: vertical distance from the suprasternal notch to the inframammary crease
|
-0.7 cm change from baseline
Standard Deviation 0.8
|
|
Change in Morphometric Breast Measurements at Day 90
SSN-base: vertical distance from the suprasternal notch to the lowest point on the base
|
-1.1 cm change from baseline
Standard Deviation 0.8
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 180-DayBilateral analysis of change to Morphometric breast measurements as per Brown, An Analysis of Ptosis at baseline and at D180.
Outcome measures
| Measure |
Renuvion APR System
n=15 Participants
Subjects treated with the Renuvion APR system in both breasts.
Renuvion APR System: The treatment area is defined as superior most not to exceed a horizontal line from the superior aspect of the axilla to the midline; inferior most not to cross the junction of the breast with the abdomen (inframammary fold). Lateral border to the outermost curvature of the breast or a vertical line drawn from the preaxillary line to the IMF; medial most to the innermost curvature of the breast up to 1 cm lateral to the sternal midline. The procedure will be in the intradermal and subdermal planes in the full breast area, without penetrating the breast gland.
Renuvion APR System settings will be 60-70% Power, 1.5 LPM, and up to 6 retrograde or 3 antegrade/retrograde passes, with a minimum of 2 incision sites.
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|---|---|
|
Change in Morphometric Breast Measurements at Day 180
SNN-N: measurements taken at the mid nipple diameter on both sides
|
-1.2 cm change from baseline
Standard Deviation 0.7
|
|
Change in Morphometric Breast Measurements at Day 180
IMC-N: measurement taken from the base of the breast to the base of the nipple
|
-0.6 cm change from baseline
Standard Deviation 0.5
|
|
Change in Morphometric Breast Measurements at Day 180
MCL-N: measurement taken from the mid clavicle to the mid nipple
|
-0.9 cm change from baseline
Standard Deviation 0.7
|
|
Change in Morphometric Breast Measurements at Day 180
NAC: nipple-areola complex diameter
|
0.1 cm change from baseline
Standard Deviation 0.4
|
|
Change in Morphometric Breast Measurements at Day 180
PROJ: maximum point of breast projection measured perpendicular to the chest wall
|
0.3 cm change from baseline
Standard Deviation 1.2
|
|
Change in Morphometric Breast Measurements at Day 180
N-N: measurements taken at the mid nipple diameter on both sides
|
0 cm change from baseline
Standard Deviation 1.1
|
|
Change in Morphometric Breast Measurements at Day 180
SSN-IMC: vertical distance from the suprasternal notch to the inframammary crease
|
-0.8 cm change from baseline
Standard Deviation 1.0
|
|
Change in Morphometric Breast Measurements at Day 180
SSN-base: vertical distance from the suprasternal notch to the lowest point on the base
|
-1.5 cm change from baseline
Standard Deviation 1.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 180-DayEvaluation by the investigator grading the amount of visual breast ptosis (breast laxity) by the Rainbow scale of ptosis includes 5 grades: a Grade I (no ptosis), Grade II (minimal ptosis), Grade III (moderate ptosis), Grade IV (more than moderate ptosis), V (severe ptosis) scale.
Outcome measures
| Measure |
Renuvion APR System
n=15 Participants
Subjects treated with the Renuvion APR system in both breasts.
Renuvion APR System: The treatment area is defined as superior most not to exceed a horizontal line from the superior aspect of the axilla to the midline; inferior most not to cross the junction of the breast with the abdomen (inframammary fold). Lateral border to the outermost curvature of the breast or a vertical line drawn from the preaxillary line to the IMF; medial most to the innermost curvature of the breast up to 1 cm lateral to the sternal midline. The procedure will be in the intradermal and subdermal planes in the full breast area, without penetrating the breast gland.
Renuvion APR System settings will be 60-70% Power, 1.5 LPM, and up to 6 retrograde or 3 antegrade/retrograde passes, with a minimum of 2 incision sites.
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|---|---|
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Change in Breast Ptosis Classification at Day 180
Grade III
|
0 Participants
|
|
Change in Breast Ptosis Classification at Day 180
Grade IV
|
0 Participants
|
|
Change in Breast Ptosis Classification at Day 180
Grade V
|
0 Participants
|
|
Change in Breast Ptosis Classification at Day 180
Grade I
|
6 Participants
|
|
Change in Breast Ptosis Classification at Day 180
Grade II
|
9 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 30-DayThe investigator will grade the overall improvement of treatment area as very much improved, much improved, improved, no change, worse, much worse, or very much worse.
Outcome measures
| Measure |
Renuvion APR System
n=15 Participants
Subjects treated with the Renuvion APR system in both breasts.
Renuvion APR System: The treatment area is defined as superior most not to exceed a horizontal line from the superior aspect of the axilla to the midline; inferior most not to cross the junction of the breast with the abdomen (inframammary fold). Lateral border to the outermost curvature of the breast or a vertical line drawn from the preaxillary line to the IMF; medial most to the innermost curvature of the breast up to 1 cm lateral to the sternal midline. The procedure will be in the intradermal and subdermal planes in the full breast area, without penetrating the breast gland.
Renuvion APR System settings will be 60-70% Power, 1.5 LPM, and up to 6 retrograde or 3 antegrade/retrograde passes, with a minimum of 2 incision sites.
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|---|---|
|
Investigator Global Aesthetic Improvement Scale (GAIS) at Day 30
Very Much Improved
|
1 Participants
|
|
Investigator Global Aesthetic Improvement Scale (GAIS) at Day 30
Much Improved
|
10 Participants
|
|
Investigator Global Aesthetic Improvement Scale (GAIS) at Day 30
Improved
|
4 Participants
|
|
Investigator Global Aesthetic Improvement Scale (GAIS) at Day 30
No Change
|
0 Participants
|
|
Investigator Global Aesthetic Improvement Scale (GAIS) at Day 30
Worse
|
0 Participants
|
|
Investigator Global Aesthetic Improvement Scale (GAIS) at Day 30
Much Worse
|
0 Participants
|
|
Investigator Global Aesthetic Improvement Scale (GAIS) at Day 30
Very Much Worse
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 90-DayThe investigator will grade the overall improvement of treatment area as very much improved, much improved, improved, no change, worse, much worse, or very much worse.
Outcome measures
| Measure |
Renuvion APR System
n=15 Participants
Subjects treated with the Renuvion APR system in both breasts.
Renuvion APR System: The treatment area is defined as superior most not to exceed a horizontal line from the superior aspect of the axilla to the midline; inferior most not to cross the junction of the breast with the abdomen (inframammary fold). Lateral border to the outermost curvature of the breast or a vertical line drawn from the preaxillary line to the IMF; medial most to the innermost curvature of the breast up to 1 cm lateral to the sternal midline. The procedure will be in the intradermal and subdermal planes in the full breast area, without penetrating the breast gland.
Renuvion APR System settings will be 60-70% Power, 1.5 LPM, and up to 6 retrograde or 3 antegrade/retrograde passes, with a minimum of 2 incision sites.
|
|---|---|
|
Investigator Global Aesthetic Improvement Scale (GAIS) at Day 90
Very Much Improved
|
4 Participants
|
|
Investigator Global Aesthetic Improvement Scale (GAIS) at Day 90
Much Improved
|
9 Participants
|
|
Investigator Global Aesthetic Improvement Scale (GAIS) at Day 90
Improved
|
2 Participants
|
|
Investigator Global Aesthetic Improvement Scale (GAIS) at Day 90
No Change
|
0 Participants
|
|
Investigator Global Aesthetic Improvement Scale (GAIS) at Day 90
Worse
|
0 Participants
|
|
Investigator Global Aesthetic Improvement Scale (GAIS) at Day 90
Much Worse
|
0 Participants
|
|
Investigator Global Aesthetic Improvement Scale (GAIS) at Day 90
Very Much Worse
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 180-DayThe investigator will grade the overall improvement of treatment area as very much improved, much improved, improved, no change, worse, much worse, or very much worse.
Outcome measures
| Measure |
Renuvion APR System
n=15 Participants
Subjects treated with the Renuvion APR system in both breasts.
Renuvion APR System: The treatment area is defined as superior most not to exceed a horizontal line from the superior aspect of the axilla to the midline; inferior most not to cross the junction of the breast with the abdomen (inframammary fold). Lateral border to the outermost curvature of the breast or a vertical line drawn from the preaxillary line to the IMF; medial most to the innermost curvature of the breast up to 1 cm lateral to the sternal midline. The procedure will be in the intradermal and subdermal planes in the full breast area, without penetrating the breast gland.
Renuvion APR System settings will be 60-70% Power, 1.5 LPM, and up to 6 retrograde or 3 antegrade/retrograde passes, with a minimum of 2 incision sites.
|
|---|---|
|
Investigator Global Aesthetic Improvement Scale (GAIS) at Day 180
Very Much Improved
|
10 Participants
|
|
Investigator Global Aesthetic Improvement Scale (GAIS) at Day 180
Much Improved
|
5 Participants
|
|
Investigator Global Aesthetic Improvement Scale (GAIS) at Day 180
Improved
|
0 Participants
|
|
Investigator Global Aesthetic Improvement Scale (GAIS) at Day 180
No Change
|
0 Participants
|
|
Investigator Global Aesthetic Improvement Scale (GAIS) at Day 180
Worse
|
0 Participants
|
|
Investigator Global Aesthetic Improvement Scale (GAIS) at Day 180
Much Worse
|
0 Participants
|
|
Investigator Global Aesthetic Improvement Scale (GAIS) at Day 180
Very Much Worse
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 30-DayThe Subject will grade overall improvement of treatment area as very much improved, much improved, improved, no change, worse, much worse, or very much worse.
Outcome measures
| Measure |
Renuvion APR System
n=15 Participants
Subjects treated with the Renuvion APR system in both breasts.
Renuvion APR System: The treatment area is defined as superior most not to exceed a horizontal line from the superior aspect of the axilla to the midline; inferior most not to cross the junction of the breast with the abdomen (inframammary fold). Lateral border to the outermost curvature of the breast or a vertical line drawn from the preaxillary line to the IMF; medial most to the innermost curvature of the breast up to 1 cm lateral to the sternal midline. The procedure will be in the intradermal and subdermal planes in the full breast area, without penetrating the breast gland.
Renuvion APR System settings will be 60-70% Power, 1.5 LPM, and up to 6 retrograde or 3 antegrade/retrograde passes, with a minimum of 2 incision sites.
|
|---|---|
|
Subject Global Aesthetic Improvement Scale (GAIS) at Day 30
Improved
|
3 Participants
|
|
Subject Global Aesthetic Improvement Scale (GAIS) at Day 30
No Change
|
0 Participants
|
|
Subject Global Aesthetic Improvement Scale (GAIS) at Day 30
Worse
|
0 Participants
|
|
Subject Global Aesthetic Improvement Scale (GAIS) at Day 30
Much Worse
|
0 Participants
|
|
Subject Global Aesthetic Improvement Scale (GAIS) at Day 30
Very Much Worse
|
0 Participants
|
|
Subject Global Aesthetic Improvement Scale (GAIS) at Day 30
Very Much Improved
|
1 Participants
|
|
Subject Global Aesthetic Improvement Scale (GAIS) at Day 30
Much Improved
|
11 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 90-DayThe Subject will grade overall improvement of treatment area as very much improved, much improved, improved, no change, worse, much worse, or very much worse.
Outcome measures
| Measure |
Renuvion APR System
n=15 Participants
Subjects treated with the Renuvion APR system in both breasts.
Renuvion APR System: The treatment area is defined as superior most not to exceed a horizontal line from the superior aspect of the axilla to the midline; inferior most not to cross the junction of the breast with the abdomen (inframammary fold). Lateral border to the outermost curvature of the breast or a vertical line drawn from the preaxillary line to the IMF; medial most to the innermost curvature of the breast up to 1 cm lateral to the sternal midline. The procedure will be in the intradermal and subdermal planes in the full breast area, without penetrating the breast gland.
Renuvion APR System settings will be 60-70% Power, 1.5 LPM, and up to 6 retrograde or 3 antegrade/retrograde passes, with a minimum of 2 incision sites.
|
|---|---|
|
Subject Global Aesthetic Improvement Scale (GAIS) at Day 90
Much Worse
|
0 Participants
|
|
Subject Global Aesthetic Improvement Scale (GAIS) at Day 90
Very Much Worse
|
0 Participants
|
|
Subject Global Aesthetic Improvement Scale (GAIS) at Day 90
Worse
|
0 Participants
|
|
Subject Global Aesthetic Improvement Scale (GAIS) at Day 90
Very Much Improved
|
4 Participants
|
|
Subject Global Aesthetic Improvement Scale (GAIS) at Day 90
Much Improved
|
8 Participants
|
|
Subject Global Aesthetic Improvement Scale (GAIS) at Day 90
Improved
|
3 Participants
|
|
Subject Global Aesthetic Improvement Scale (GAIS) at Day 90
No Change
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 180-DayThe Subject will grade overall improvement of treatment area as very much improved, much improved, improved, no change, worse, much worse, or very much worse.
Outcome measures
| Measure |
Renuvion APR System
n=15 Participants
Subjects treated with the Renuvion APR system in both breasts.
Renuvion APR System: The treatment area is defined as superior most not to exceed a horizontal line from the superior aspect of the axilla to the midline; inferior most not to cross the junction of the breast with the abdomen (inframammary fold). Lateral border to the outermost curvature of the breast or a vertical line drawn from the preaxillary line to the IMF; medial most to the innermost curvature of the breast up to 1 cm lateral to the sternal midline. The procedure will be in the intradermal and subdermal planes in the full breast area, without penetrating the breast gland.
Renuvion APR System settings will be 60-70% Power, 1.5 LPM, and up to 6 retrograde or 3 antegrade/retrograde passes, with a minimum of 2 incision sites.
|
|---|---|
|
Subject Global Aesthetic Improvement Scale (GAIS) at Day 180
Very Much Improved
|
10 Participants
|
|
Subject Global Aesthetic Improvement Scale (GAIS) at Day 180
Much Improved
|
5 Participants
|
|
Subject Global Aesthetic Improvement Scale (GAIS) at Day 180
Improved
|
0 Participants
|
|
Subject Global Aesthetic Improvement Scale (GAIS) at Day 180
No Change
|
0 Participants
|
|
Subject Global Aesthetic Improvement Scale (GAIS) at Day 180
Worse
|
0 Participants
|
|
Subject Global Aesthetic Improvement Scale (GAIS) at Day 180
Much Worse
|
0 Participants
|
|
Subject Global Aesthetic Improvement Scale (GAIS) at Day 180
Very Much Worse
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 180-DaySubjects will be asked to complete a satisfaction survey referring to the assessment of baseline photos, current photos, and a mirror. Yes/No - Did you notice any improvement in the laxity or sagginess of your breasts? If yes, checkbox - Less sagging, Breasts look higher on the chest, Nipple placement is improved, Breasts appear more youthful, and/or Other. How would you characterize your satisfaction with the treatment? - very satisfied, satisfied, slightly satisfied, neither satisfied or dissatisfied, slightly dissatisfied, dissatisfied, very dissatisfied. Yes/No - Would you recommend this treatment to your friends and family members?
Outcome measures
| Measure |
Renuvion APR System
n=15 Participants
Subjects treated with the Renuvion APR system in both breasts.
Renuvion APR System: The treatment area is defined as superior most not to exceed a horizontal line from the superior aspect of the axilla to the midline; inferior most not to cross the junction of the breast with the abdomen (inframammary fold). Lateral border to the outermost curvature of the breast or a vertical line drawn from the preaxillary line to the IMF; medial most to the innermost curvature of the breast up to 1 cm lateral to the sternal midline. The procedure will be in the intradermal and subdermal planes in the full breast area, without penetrating the breast gland.
Renuvion APR System settings will be 60-70% Power, 1.5 LPM, and up to 6 retrograde or 3 antegrade/retrograde passes, with a minimum of 2 incision sites.
|
|---|---|
|
Patient Satisfaction Questionnaire (PSQ) at Day 180
Yes, Improvement Noticed in Breast Area
|
15 participants
|
|
Patient Satisfaction Questionnaire (PSQ) at Day 180
Yes, Less Sagging Breasts
|
15 participants
|
|
Patient Satisfaction Questionnaire (PSQ) at Day 180
Yes, Breasts Look Higher on Chest
|
15 participants
|
|
Patient Satisfaction Questionnaire (PSQ) at Day 180
Yes, Nipple Placement is Improved
|
15 participants
|
|
Patient Satisfaction Questionnaire (PSQ) at Day 180
Yes, Breasts Appear More Youthful
|
15 participants
|
|
Patient Satisfaction Questionnaire (PSQ) at Day 180
Yes, Would recommend to friends and family
|
15 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 180-DaySubjects will complete the Psychosocial Well-Being and Sexual Well-Being questionnaires. Subjects were instructed "With your breasts in mind, in the past week, how often have you felt:". Responses were 5 options: 1 - None of the time, 2 - A little of the time, 3 - Some of the time, 4 - Most of the time, 5 - All of the time.
Outcome measures
| Measure |
Renuvion APR System
n=15 Participants
Subjects treated with the Renuvion APR system in both breasts.
Renuvion APR System: The treatment area is defined as superior most not to exceed a horizontal line from the superior aspect of the axilla to the midline; inferior most not to cross the junction of the breast with the abdomen (inframammary fold). Lateral border to the outermost curvature of the breast or a vertical line drawn from the preaxillary line to the IMF; medial most to the innermost curvature of the breast up to 1 cm lateral to the sternal midline. The procedure will be in the intradermal and subdermal planes in the full breast area, without penetrating the breast gland.
Renuvion APR System settings will be 60-70% Power, 1.5 LPM, and up to 6 retrograde or 3 antegrade/retrograde passes, with a minimum of 2 incision sites.
|
|---|---|
|
Breast-Q Survey
Confident in a social setting?
|
4.3 average units on a scale
Standard Deviation 0.5
|
|
Breast-Q Survey
Good about yourself?
|
4.5 average units on a scale
Standard Deviation 0.5
|
|
Breast-Q Survey
Confident in your clothes?
|
4.5 average units on a scale
Standard Deviation 0.5
|
|
Breast-Q Survey
Of equal worth to other women?
|
4.3 average units on a scale
Standard Deviation 0.5
|
|
Breast-Q Survey
Attractive?
|
4.2 average units on a scale
Standard Deviation 0.6
|
|
Breast-Q Survey
Accepting of your body?
|
4.4 average units on a scale
Standard Deviation 0.6
|
|
Breast-Q Survey
Self-assured?
|
4.4 average units on a scale
Standard Deviation 0.5
|
|
Breast-Q Survey
Confident about your body?
|
4.5 average units on a scale
Standard Deviation 0.5
|
|
Breast-Q Survey
Self-confident?
|
4.7 average units on a scale
Standard Deviation 0.5
|
|
Breast-Q Survey
Sexually attractive in your clothes?
|
4.2 average units on a scale
Standard Deviation 0.6
|
|
Breast-Q Survey
Comfortable/at ease during sexual activity?
|
4.3 average units on a scale
Standard Deviation 0.6
|
|
Breast-Q Survey
Confident sexually?
|
4.3 average units on a scale
Standard Deviation 0.5
|
|
Breast-Q Survey
Sexy when unclothed?
|
4.4 average units on a scale
Standard Deviation 0.6
|
|
Breast-Q Survey
Confident sexually about how your breasts look when unclothed?
|
4.2 average units on a scale
Standard Deviation 0.6
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Procedure Day 0 (within 60 minutes following treatment)Study subjects will be asked to complete a 11-point Numeric Rating Scale (NRS) for the level of pain and discomfort associated with the study procedure. Rating Scale where 0 is "No Pain" and 10 is "Worst Possible Pain"
Outcome measures
| Measure |
Renuvion APR System
n=15 Participants
Subjects treated with the Renuvion APR system in both breasts.
Renuvion APR System: The treatment area is defined as superior most not to exceed a horizontal line from the superior aspect of the axilla to the midline; inferior most not to cross the junction of the breast with the abdomen (inframammary fold). Lateral border to the outermost curvature of the breast or a vertical line drawn from the preaxillary line to the IMF; medial most to the innermost curvature of the breast up to 1 cm lateral to the sternal midline. The procedure will be in the intradermal and subdermal planes in the full breast area, without penetrating the breast gland.
Renuvion APR System settings will be 60-70% Power, 1.5 LPM, and up to 6 retrograde or 3 antegrade/retrograde passes, with a minimum of 2 incision sites.
|
|---|---|
|
Average Reported by Subject at Procedure
0
|
15 Participants
|
|
Average Reported by Subject at Procedure
1
|
0 Participants
|
|
Average Reported by Subject at Procedure
2
|
0 Participants
|
|
Average Reported by Subject at Procedure
3
|
0 Participants
|
|
Average Reported by Subject at Procedure
4
|
0 Participants
|
|
Average Reported by Subject at Procedure
5
|
0 Participants
|
|
Average Reported by Subject at Procedure
6
|
0 Participants
|
|
Average Reported by Subject at Procedure
7
|
0 Participants
|
|
Average Reported by Subject at Procedure
8
|
0 Participants
|
|
Average Reported by Subject at Procedure
9
|
0 Participants
|
|
Average Reported by Subject at Procedure
10
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 30-DayStudy subjects will be asked to complete a 11-point Numeric Rating Scale (NRS) for the level of pain and discomfort associated with the study procedure. Rating Scale where 0 is "No Pain" and 10 is "Worst Possible Pain"
Outcome measures
| Measure |
Renuvion APR System
n=15 Participants
Subjects treated with the Renuvion APR system in both breasts.
Renuvion APR System: The treatment area is defined as superior most not to exceed a horizontal line from the superior aspect of the axilla to the midline; inferior most not to cross the junction of the breast with the abdomen (inframammary fold). Lateral border to the outermost curvature of the breast or a vertical line drawn from the preaxillary line to the IMF; medial most to the innermost curvature of the breast up to 1 cm lateral to the sternal midline. The procedure will be in the intradermal and subdermal planes in the full breast area, without penetrating the breast gland.
Renuvion APR System settings will be 60-70% Power, 1.5 LPM, and up to 6 retrograde or 3 antegrade/retrograde passes, with a minimum of 2 incision sites.
|
|---|---|
|
Average Reported Pain by Subject at Day 30
0
|
15 Participants
|
|
Average Reported Pain by Subject at Day 30
1
|
0 Participants
|
|
Average Reported Pain by Subject at Day 30
2
|
0 Participants
|
|
Average Reported Pain by Subject at Day 30
3
|
0 Participants
|
|
Average Reported Pain by Subject at Day 30
4
|
0 Participants
|
|
Average Reported Pain by Subject at Day 30
5
|
0 Participants
|
|
Average Reported Pain by Subject at Day 30
6
|
0 Participants
|
|
Average Reported Pain by Subject at Day 30
7
|
0 Participants
|
|
Average Reported Pain by Subject at Day 30
8
|
0 Participants
|
|
Average Reported Pain by Subject at Day 30
9
|
0 Participants
|
|
Average Reported Pain by Subject at Day 30
10
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 90-DayStudy subjects will be asked to complete a 11-point Numeric Rating Scale (NRS) for the level of pain and discomfort associated with the study procedure. Rating Scale where 0 is "No Pain" and 10 is "Worst Possible Pain"
Outcome measures
| Measure |
Renuvion APR System
n=15 Participants
Subjects treated with the Renuvion APR system in both breasts.
Renuvion APR System: The treatment area is defined as superior most not to exceed a horizontal line from the superior aspect of the axilla to the midline; inferior most not to cross the junction of the breast with the abdomen (inframammary fold). Lateral border to the outermost curvature of the breast or a vertical line drawn from the preaxillary line to the IMF; medial most to the innermost curvature of the breast up to 1 cm lateral to the sternal midline. The procedure will be in the intradermal and subdermal planes in the full breast area, without penetrating the breast gland.
Renuvion APR System settings will be 60-70% Power, 1.5 LPM, and up to 6 retrograde or 3 antegrade/retrograde passes, with a minimum of 2 incision sites.
|
|---|---|
|
Average Reported Pain by Subject at Day 90
0
|
15 Participants
|
|
Average Reported Pain by Subject at Day 90
1
|
0 Participants
|
|
Average Reported Pain by Subject at Day 90
2
|
0 Participants
|
|
Average Reported Pain by Subject at Day 90
3
|
0 Participants
|
|
Average Reported Pain by Subject at Day 90
4
|
0 Participants
|
|
Average Reported Pain by Subject at Day 90
5
|
0 Participants
|
|
Average Reported Pain by Subject at Day 90
6
|
0 Participants
|
|
Average Reported Pain by Subject at Day 90
7
|
0 Participants
|
|
Average Reported Pain by Subject at Day 90
8
|
0 Participants
|
|
Average Reported Pain by Subject at Day 90
9
|
0 Participants
|
|
Average Reported Pain by Subject at Day 90
10
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 180-DayStudy subjects will be asked to complete a 11-point Numeric Rating Scale (NRS) for the level of pain and discomfort associated with the study procedure. Rating Scale where 0 is "No Pain" and 10 is "Worst Possible Pain"
Outcome measures
| Measure |
Renuvion APR System
n=15 Participants
Subjects treated with the Renuvion APR system in both breasts.
Renuvion APR System: The treatment area is defined as superior most not to exceed a horizontal line from the superior aspect of the axilla to the midline; inferior most not to cross the junction of the breast with the abdomen (inframammary fold). Lateral border to the outermost curvature of the breast or a vertical line drawn from the preaxillary line to the IMF; medial most to the innermost curvature of the breast up to 1 cm lateral to the sternal midline. The procedure will be in the intradermal and subdermal planes in the full breast area, without penetrating the breast gland.
Renuvion APR System settings will be 60-70% Power, 1.5 LPM, and up to 6 retrograde or 3 antegrade/retrograde passes, with a minimum of 2 incision sites.
|
|---|---|
|
Average Reported Pain by Subject at Day 180
0
|
15 Participants
|
|
Average Reported Pain by Subject at Day 180
1
|
0 Participants
|
|
Average Reported Pain by Subject at Day 180
2
|
0 Participants
|
|
Average Reported Pain by Subject at Day 180
3
|
0 Participants
|
|
Average Reported Pain by Subject at Day 180
4
|
0 Participants
|
|
Average Reported Pain by Subject at Day 180
5
|
0 Participants
|
|
Average Reported Pain by Subject at Day 180
6
|
0 Participants
|
|
Average Reported Pain by Subject at Day 180
7
|
0 Participants
|
|
Average Reported Pain by Subject at Day 180
8
|
0 Participants
|
|
Average Reported Pain by Subject at Day 180
9
|
0 Participants
|
|
Average Reported Pain by Subject at Day 180
10
|
0 Participants
|
Adverse Events
Renuvion APR System
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Kari Larson, Sr. Director of Clinical Affairs
Apyx Medical
Phone: 8012440058
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place