Ulthera DeepSEE DS 4 - 4.5, Инструкция по эксплуатации

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Ulthera, Inc
6.1.3. Décolleté
6.1.3.1. Clinical Trial Results
To support the expanded indication, the Ulthera System was evaluated in a
prospective safety and efficacy study investigating the clinical response
following treatment with the Ulthera System to achieve improvement of lines
and wrinkles of the décolleté. The clinical study’s protocol was approved
under IDE G120004 for enrolling up to 130 female subjects between the ages
of 35-60 at up to 4 sites with a 90 and 180 day follow up. The Fabi-Bolton Scale,
a published validated scale, was prospectively defined to evaluate wrinkle
improvement. However, successful validation of the Fabi-Bolton Scale during
the clinical trial could not be accomplished due to kappa scores for both intra-
rater and inter-rater reproducibility being low. Therefore, the primary endpoint
was changed from the Fabi-Bolton Scale to a post-hoc retrospective masked
assessment of pre and post treatment photographs. There were no pre-
specified success criteria of the masked assessment established at the
beginning of the clinical trial. In addition to masked assessment, there was also
an unmasked assessment called the Clinician Global Aesthetic Improvement
Scores (CGAIS). Finally, patient satisfaction questionnaires were also measured
to assess improvement.
Table 6.4 Patient Accountability
N 125
Subject Drop out 17
Subject Per Protocol 108
Subject Eliminated based
on Poor Quality
Photographs
54
Evaluable Subjects 54
Upon analysis of the all the photographs used in the clinical study, 54 of 108
day 180 photos were identified as having inconsistencies in photo quality
(changes in lighting, color, focus, patient positioning, cropping, etc.). Therefore
a sub-set analysis was conducted using the primary endpoint of masked
assessment on the remaining 54 day 180 evaluable photo sets that were
deemed the most consistent in photo quality.
Table 6.4 provides results from the masked assessment of the evaluable subject
photos.