Safety and clinical performance of the BMR Face device (manufactured by Bio-Medical Research)
Evaluate the efficacy of the BMR Face device in relation to facial appearance at 12 weeks compared to baseline. Efficacy will be assessed by overall facial improvement assessed live by the Investigator and a subject assessment of facial appearance including the Global Aesthetic Improvement Scale (GAIS). The Global Aesthetic Improvement Scale is a five-grade subjective test. The physician and patient independently describe the degree of improvement in facial appearance. Possible responses were (1) Significantly marked improvement, (2) marked improvement, (3) moderate improvement, (4) slight improvement, (5) no improvement Secondary objectives are to evaluate safety and further evaluate the subject's and investigator's satisfaction (both a live and blinded assessor) with the BMR Face treatment.
Study Type
INTERVENTIONAL
Allocation
NA
Masking
NONE
Enrollment
30
BMR Face used in accordance with manufacturer IFU
Sadick Research Group
New York, New Jersey, United States
Evaluate Overall Facial Improvement Assessed Live by the Investigator and Subjects Using the Global Aesthetic Improvement Scale (GAIS) at 12 Weeks Compared to Baseline.
Evaluate the efficacy of the Efficacy will be assessed by overall facial improvement assessed live by the Investigator and a subject assessment of facial appearance including the Global Aesthetic Improvement Scale (GAIS). The Global Aesthetic Improvement Scale is a five-grade subjective test. The physician and patient independently describe the degree of improvement in facial appearance. Possible responses were (1) Significantly marked improvement, (2) marked improvement, (3) moderate improvement, (4) slight improvement, (5) no improvement. For reporting of outcomes, the higher the GAIS value, the greater the improvement (Range 0-4).
Time frame: 12 weeks
To Evaluate Overall Facial Improvement Assessed Live by the Investigator and Subjects Including the Global Aesthetic Improvement Scale (GAIS) at 6 Weeks Compared to Baseline
Evaluate the efficacy of the Efficacy will be assessed by overall facial improvement assessed live by the Investigator and a subject assessment of facial appearance including the Global Aesthetic Improvement Scale (GAIS). The Global Aesthetic Improvement Scale is a five-grade subjective test. The physician and patient independently describe the degree of improvement in facial appearance. Possible responses were (1) Significantly marked improvement, (2) marked improvement, (3) moderate improvement, (4) slight improvement, (5) no improvement. For reporting of outcomes, the higher the GAIS value, the greater the improvement (Range 0-4).
Time frame: 6 weeks
To Evaluate the Subject's Satisfaction With BMR Face Treatment at 6 Weeks and 12 Weeks (Subject Self- Assessment).
The Subject Satisfaction Assessment Scale is a 5 point scale where a subject rates their satisfaction level as Very Satisfied, Satisfied, No Opinion, Unsatisfied or Very Unsatisfied.
Time frame: 6 weeks, 12 weeks
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