Treatment of Fibrotic Scars With Rapid Acoustic Pulse (RAP) Device

Study Overview
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Brief Summary
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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

Detailed Description
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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'

Official Title
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Soliton's Rapid Acoustic Pulse (RAP) Device for the Treatment of Fibrotic Scars: Multi-Treatment Proof-of-Concept Study

Conditions
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Scars, Hypertrophic

Intervention / Treatment
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* Device: Treatment of hypertrophic scars (Soliton's Rapid Acoustic Pulse (RAP) Device)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female 18 years of age or older at the screening visit. The participant is healthy, as determined by the investigator based on a medical evaluation including medical history. The participant has a fibrotic scar (keloid or hypertrophic scar) that is easily delineated photographically located on the chest, back, trunk, upper arms or upper legs. Scar must be located an essentially planar surface. Scar size preferably between 2.5 cm2 and 5 cm2. Preferably, the scar length is greater than 25 mm; and height greater than 2.5 mm. Scar less than 5 years old. Participant is willing to forego any other scar treatments until complete with study participation. Participant is willing to participate in study and adhere to follow-up schedule. Participant is able to read and comprehend English. Regardless of the above, the final decision on scar inclusion will rest with the PI. Exclusion Criteria: Participant is sensitive to loud sounds Participant had treatments, including topical steroids, to the scar being treated in the study in the prior 12 months. Participant is unwilling to have research photos taken of treatment areas in the presence of Sponsor's researchers. Participant is unwilling to have RAP treatment provided in the presence of Sponsor's researchers. Participant is pregnant or planning to become pregnant during the duration of the study. Metal or plastic implants near the area of the treatment (vascular stent, plates and screws, chest wires, hips, knees, elbows, etc.). Active electronic implants such as pacemakers, defibrillators, cochlear implants, nerve/brain stimulators, drug pump, etc. Medical disorder that would hinder the wound healing or immune response (no blood disorder, etc.). History of coagulopathy(ies) and/or on anticoagulant medication. Skin disorders (skin infections or rashes, extensive scarring, psoriasis, etc.) in the treatment area. Current smoker. Any surgical procedure in the prior 3 months, or planned during the duration of the study. Any issue that, at the discretion of the Investigator, would interfere with assessment of safety or efficacy or compromise the participant's ability to fulfill study obligations Treatment with another investigational device or agent within 30 days before treatment or during the study period

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Three treatments to hypertrophic scar with RAP device<br>RAP treatments will be administered to the scar every +/- 2 weeks for a total of 3 treatments | Device: Treatment of hypertrophic scars (Soliton's Rapid Acoustic Pulse (RAP) Device)<br>* Administration of 3 Rapid Acoustic Pulse (RAP) treatments<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 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. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 12 weeks |