search
Back to results

Treatment 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
Soliton
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Scars, Hypertrophic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Male or female 18 years of age or older at the screening visit.
  2. The participant is healthy, as determined by the investigator based on a medical evaluation including medical history.
  3. 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.
  4. Scar must be located an essentially planar surface.
  5. Scar size preferably between 2.5 cm2 and 5 cm2.
  6. Preferably, the scar length is greater than 25 mm; and height greater than 2.5 mm.
  7. Scar less than 5 years old.
  8. Participant is willing to forego any other scar treatments until complete with study participation.
  9. Participant is willing to participate in study and adhere to follow-up schedule.
  10. 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:

  1. Participant is sensitive to loud sounds
  2. Participant had treatments, including topical steroids, to the scar being treated in the study in the prior 12 months.
  3. Participant is unwilling to have research photos taken of treatment areas in the presence of Sponsor's researchers.
  4. Participant is unwilling to have RAP treatment provided in the presence of Sponsor's researchers.
  5. Participant is pregnant or planning to become pregnant during the duration of the study.
  6. Metal or plastic implants near the area of the treatment (vascular stent, plates and screws, chest wires, hips, knees, elbows, etc.).
  7. Active electronic implants such as pacemakers, defibrillators, cochlear implants, nerve/brain stimulators, drug pump, etc.
  8. Medical disorder that would hinder the wound healing or immune response (no blood disorder, etc.).
  9. History of coagulopathy(ies) and/or on anticoagulant medication.
  10. Skin disorders (skin infections or rashes, extensive scarring, psoriasis, etc.) in the treatment area.
  11. Current smoker.
  12. Any surgical procedure in the prior 3 months, or planned during the duration of the study.
  13. 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
  14. 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

    First Posted
    January 4, 2021
    Last Updated
    February 8, 2022
    Sponsor
    Soliton
    Collaborators
    United States Naval Medical Center, San Diego
    search

    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

    We'll reach out to this number within 24 hrs