Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Other |
Change in Morphometric Breast Measurements at Day 30 |
Bilateral analysis of change to Morphometric breast measurements as per Brown, An Analysis of Ptosis at baseline and at D30. |
30-Day |
|
Other |
Change in Morphometric Breast Measurements at Day 90 |
Bilateral analysis of change to Morphometric breast measurements as per Brown, An Analysis of Ptosis at baseline and at D90. |
90-Day |
|
Other |
Change in Morphometric Breast Measurements at Day 180 |
Bilateral analysis of change to Morphometric breast measurements as per Brown, An Analysis of Ptosis at baseline and at D180. |
180-Day |
|
Other |
Change in Breast Ptosis Classification at Day 180 |
Bilateral analysis of change to Ptosis Classification per the Eyck et al, Rainbow Scale for Assessing Breast Ptosis at baseline and at D180. |
180-Day |
|
Other |
Investigator Global Aesthetic Improvement Scale (GAIS) at Day 30 |
The 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. |
30-Day |
|
Other |
Investigator Global Aesthetic Improvement Scale (GAIS) at Day 90 |
The 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. |
90-Day |
|
Other |
Investigator Global Aesthetic Improvement Scale (GAIS) at Day 180 |
The 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. |
180-Day |
|
Other |
Subject Global Aesthetic Improvement Scale (GAIS) at Day 30 |
The Subject will grade overall improvement of treatment area as very much improved, much improved, improved, no change, worse, much worse, or very much worse. |
30-Day |
|
Other |
Subject Global Aesthetic Improvement Scale (GAIS) at Day 90 |
The Subject will grade overall improvement of treatment area as very much improved, much improved, improved, no change, worse, much worse, or very much worse. |
90-Day |
|
Other |
Subject Global Aesthetic Improvement Scale (GAIS) at Day 180 |
The Subject will grade overall improvement of treatment area as very much improved, much improved, improved, no change, worse, much worse, or very much worse. |
180-Day |
|
Other |
Patient Satisfaction Questionnaire (PSQ) at Day 180 |
Subjects 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? |
180-Day |
|
Other |
Breast-Q Survey |
Subjects will be asked to complete a Breast-Q survey at baseline and Day 180. Subjects will complete the Psychosocial Well-Being and Sexual Well-Being questionnaires. Analysis of change in scores will be assessed between baseline and Day 180. |
180-Day |
|
Other |
Adverse Events |
Analysis of adverse events through the D180. |
180-Day |
|
Other |
Average Reported by Subject at Procedure |
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" |
Procedure Day 0 |
|
Other |
Average Reported by Subject at Day 30 |
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" |
30-Day |
|
Other |
Average Reported by Subject at Day 90 |
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" |
90-Day |
|
Other |
Average Reported by Subject at Day 180 |
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" |
180-Day |
|
Primary |
Independent Photographic Review of before and after images compared to baseline compared to D180. |
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. |
180-Day |
|
Secondary |
Independent Photographic Review of before and after images compared to baseline at D90. |
Improvement in breast ptosis as determined by a masked, qualitative assessment of photographs at 90-days post-treatment compared to baseline by blinded independent reviewers. |
90-Day |
|