- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04702529
Treatment of Fibrotic Scars With Rapid Acoustic Pulse (RAP) Device
February 8, 2022 updated by: Soliton
Soliton's Rapid Acoustic Pulse (RAP) Device for the Treatment of Fibrotic Scars: Multi-Treatment Proof-of-Concept Study
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
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
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'
Study Type
Interventional
Enrollment (Anticipated)
19
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional 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
RAP treatments will be administered to the scar every +/- 2 weeks for a total of 3 treatments
|
Administration of 3 Rapid Acoustic Pulse (RAP) treatments
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of Treatment Emergent Serious Adverse Events (SAEs) and Unexpected Adverse Events (UAEs)
Time Frame: Immediately post treatment
|
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
Time Frame: up to 14 days
|
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)
Time Frame: up to 3 week post treatment
|
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
Time Frame: 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
Time Frame: 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
Time Frame: 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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
May 1, 2022
Primary Completion (Anticipated)
August 31, 2023
Study Completion (Anticipated)
August 31, 2023
Study Registration Dates
First Submitted
January 4, 2021
First Submitted That Met QC Criteria
January 8, 2021
First Posted (Actual)
January 11, 2021
Study Record Updates
Last Update Posted (Actual)
February 14, 2022
Last Update Submitted That Met QC Criteria
February 8, 2022
Last Verified
February 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021-01
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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