An interventional study of Treatment of hypertrophic scars (Soliton's Rapid Acoustic Pulse (RAP) Device) in Scars, Hypertrophic, sponsored by Soliton. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-24.
Sponsored by Soliton · Not applicable, Interventional, and Treatment
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
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'
129 studies on the registry are indexed under Cicatrix, Hypertrophic; 31 are open to participants now.
This study's enrollment of 20 is below the median of 36 across 106 interventional studies indexed under Cicatrix, Hypertrophic.
Browse Cicatrix, Hypertrophic studies →Soliton is the lead sponsor of 7 studies on the registry; none are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Regardless of the above, the final decision on scar inclusion will rest with the PI.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
Administration of 3 Rapid Acoustic Pulse (RAP) treatments
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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 12 weeks
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.
Time frame: 12 weeks
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.
Time frame: 12 weeks
This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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