Proof of Concept (POC) Study of the Soliton's Acoustic Scar Reduction (ASR) Treatment for the Treatment of Keloid Scar

Study Overview
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Brief Summary
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To evaluate the safety, and efficacy of the ASR device for the temporary improvement in the appearance of a keloids.

Detailed Description
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To evaluate the safety, and efficacy of the ASR device for the temporary improvement in the appearance of a keloids. To demonstrate improvement in the keloid scars, without unexpected adverse events (UAEs) and serious adverse events (SAEs) directly attributable to the ASR device or treatment.

Official Title
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Proof of Concept (POC) Study of the Soliton's Acoustic Scar Reduction (ASR) Treatment Using Rapid Acoustic Pulse (RAP) Device for the Treatment of Keloid Scar

Conditions
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Keloid Scar

Intervention / Treatment
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* Device: Soliton's Acoustic Scar Reduction (SAR)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female older than 18 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 keloid that is easily delineated photographically located on the chest, back, trunk or upper arms and legs. Keloid size greater than 1 cm and less than 8 cm in length, with a height of at least 2 mm. Keloids less than 5 years old Body Mass Index (B.M.I.) is > 20 Participant is willing to not undergo any other keloid treatments for a period of 12 months following ASR treatment. Participant is willing to participate in study and adhere to follow-up schedule. Participant is able to read and comprehend English or Spanish. Participant has completed the Informed Consent Form. Exclusion Criteria: Participant had treatments, including topical steroids, to the keloid 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 ASR 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, elbows, knees, 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.

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: Device Feasibility
Intervention Model: Single Group Assignment
Interventional Model Description: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ASR Treatment<br>Single and/or multi-treatment ASR device applied to the keloid scar for a period of 2 minutes for each 3 cm. | Device: Soliton's Acoustic Scar Reduction (SAR)<br>* Treatment of keloid scars for the temporary improvement in appearance.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedure Safety | The safety endpoint will be met if all treated participants are free from unexpected adverse events and serious adverse events directly attributable to the ASR device or treatment. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatement Tolerability | ASR treatment tolerability will be met if the average pain measure using a 0-10 pain scale across all treated Participants is < 8.0. | 12 weeks |