Back to resultsTreatment of Fibrotic Scars With Rapid Acoustic Pulse (RAP) Device
Primary Purpose
Scars, Hypertrophic
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Treatment of hypertrophic scars (Soliton's Rapid Acoustic Pulse (RAP) Device)
Sponsored by
About this trial
This is an interventional treatment trial for Scars, Hypertrophic
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Three treatments to hypertrophic scar with RAP device
Arm Description
RAP treatments will be administered to the scar every +/- 2 weeks for a total of 3 treatments
Outcomes
Primary Outcome Measures
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
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
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
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.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT04702529
First Posted
January 4, 2021
Last Updated
February 8, 2022
Sponsor
Soliton
Collaborators
United States Naval Medical Center, San Diego
1. Study Identification
Unique Protocol Identification Number
NCT04702529
Brief Title
Treatment of Fibrotic Scars With Rapid Acoustic Pulse (RAP) Device
Official Title
Soliton's Rapid Acoustic Pulse (RAP) Device for the Treatment of Fibrotic Scars: Multi-Treatment Proof-of-Concept Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 2022 (Anticipated)
Primary Completion Date
August 31, 2023 (Anticipated)
Study Completion Date
August 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Soliton
Collaborators
United States Naval Medical Center, San Diego
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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'
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scars, Hypertrophic
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Three treatments to hypertrophic scar with RAP device
Arm Type
Experimental
Arm Description
RAP treatments will be administered to the scar every +/- 2 weeks for a total of 3 treatments
Intervention Type
Device
Intervention Name(s)
Treatment of hypertrophic scars (Soliton's Rapid Acoustic Pulse (RAP) Device)
Intervention Description
Administration of 3 Rapid Acoustic Pulse (RAP) treatments
Primary Outcome Measure Information:
Title
Incidence of Treatment Emergent Serious Adverse Events (SAEs) and Unexpected Adverse Events (UAEs)
Description
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
Title
Incidence of Treatment Emergent Serious Adverse Events (SAEs) and Unexpected Adverse Events (UAEs)Procedure Safety
Description
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
Title
Incidence of Treatment Emergent Serious Adverse Events (SAEs) and Unexpected Adverse Events (UAEs)
Description
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
Title
Change from baseline scar Global Aesthetic Improvement Scale at 12 weeks
Description
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
Secondary Outcome Measure Information:
Title
Change in baseline scar Global Aesthetic Improvement scale at 12 weeks
Description
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
Title
Change in baseline scar Global Aesthetic Improvement Scale at 12 weeks
Description
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.
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
12. IPD Sharing Statement
Learn more about this trial
Treatment of Fibrotic Scars With Rapid Acoustic Pulse (RAP) Device
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