Treatment of Fibrotic Scars With Rapid Acoustic Pulse (RA... | NCT04702529

NCT04702529

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Name	Class
United States Naval Medical Center, San Diego	FED

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Three treatments to hypertrophic scar with RAP device	Experimental	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)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Treatment of hypertrophic scars (Soliton's Rapid Acoustic Pulse (RAP) Device)	Device	Administration of 3 Rapid Acoustic Pulse (RAP) treatments	Three treatments to hypertrophic scar with RAP device

Outcomes Module

Primary Outcomes

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 Outcomes

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

Eligibility Module

Eligibility Criteria

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

ID	Term
D002921	Cicatrix
D005355	Fibrosis
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms