A multi-treatment proof of concept clinical study is to evaluate the safety, and efficacy of multiple treatments with Soliton's Rapid Acoustic Pulse (RAP) device for the improvement in the appearance of fibrotic scars
Soliton's Rapid Acoustic Pulse(RAP) device is an electrohydraulic (EH) device using Soliton's Rapid Acoustic Pulse (RAP) technology developed to minimize the appearance of scars through both micro-disruption of the scar matrix leading to scar remodeling and down regulation of the 'fibrotic fibroblasts'
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Administration of 3 Rapid Acoustic Pulse (RAP) treatments
San Diego Naval Medical Center
San Diego, California, United States
Incidence of Treatment Emergent Serious Adverse Events (SAEs) and Unexpected Adverse Events (UAEs)
Incidence of unexpected adverse events and serious adverse events directly attributable to the RAP device or treatment will be reported
Time frame: Immediately post treatment
Incidence of Treatment Emergent Serious Adverse Events (SAEs) and Unexpected Adverse Events (UAEs)Procedure Safety
Incidence of unexpected adverse events and serious adverse events directly attributable to the RAP device or treatment will be reported
Time frame: up to 14 days
Incidence of Treatment Emergent Serious Adverse Events (SAEs) and Unexpected Adverse Events (UAEs)
Incidence of unexpected adverse events and serious adverse events directly attributable to the RAP device or treatment will be evaluated before each treatment which occurs every 2 weeks, (+/- 1 week) and will be reported
Time frame: up to 3 week post treatment
Change from baseline scar Global Aesthetic Improvement Scale at 12 weeks
Noted improvement in scar appearance via Global Aesthetic Improvement Scale Scale (GAIS) as reported by the Principal Investigator (PI). Minimum value 1 and maximum value 5, with higher score meaning worse outcome.
Time frame: 12 weeks
Change in baseline scar Global Aesthetic Improvement scale at 12 weeks
Noted improvement in scar via Patient and Observer Scar Assessment Scale (POSAS). Minimum value 1 and maximum value 10, with higher scores meaning a better outcome.
Time frame: 12 weeks
Change in baseline scar Global Aesthetic Improvement Scale at 12 weeks
Noted improvement in scar appearance via Global Aesthetic Improvement Scale (GAIS) as reported by the participant. Minimum value 1 and maximum value 5, with higher score meaning worse outcome.
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Time frame: 12 weeks