An interventional study of Soliton's Acoustic Scar Reduction (SAR) in Keloid Scar, 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 2021-09-28.
Sponsored by Soliton · Not applicable, Interventional, and Device feasibility
To evaluate the safety, and efficacy of the ASR device for the temporary improvement in the appearance of a keloids.
To evaluate the safety, and efficacy of the ASR device for the temporary improvement in the appearance of a keloids. To demonstrate improvement in the keloid scars, without unexpected adverse events (UAEs) and serious adverse events (SAEs) directly attributable to the ASR device or treatment.
138 studies on the registry are indexed under Keloid; 26 are open to participants now.
This study's enrollment of 9 is below the median of 30 across 109 interventional studies indexed under Keloid.
Browse Keloid 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.
Counted across the registry records on this site, refreshed daily.
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.
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.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
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.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Single and/or multi-treatment ASR device applied to the keloid scar for a period of 2 minutes for each 3 cm.
Device: Soliton's Acoustic Scar Reduction (SAR)
Treatment of keloid scars for the temporary improvement in appearance.
Procedure Safety
The safety endpoint will be met if all treated participants are free from unexpected adverse events and serious adverse events directly attributable to the ASR device or treatment.
Time frame: 12 weeks
Treatement Tolerability
ASR treatment tolerability will be met if the average pain measure using a 0-10 pain scale across all treated Participants is \< 8.0.
Time frame: 12 weeks
Plan to share: No
No publications or documents are linked to this record.
Ran from Jul 2019 to primary completion in Feb 2020, 7 months.
Of 20 interventional studies with no phase under Keloid, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 36. This study's 7 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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