Proof of Concept (POC) Study of the Soliton's Acoustic Sc... | NCT04016610

Studies
Proof of Concept (POC) Study of the Soliton's Acoustic Scar Reduction (ASR) Treatment for the Treatment of Keloid Scar

NCT04016610

Sponsor

Soliton

Status

Completed

Last Update Posted

Sep 28, 2021Actual

Enrollment

9Actual

Phase

Not Applicable

Conditions

Keloid Scar

Interventions

Soliton's Acoustic Scar Reduction (SAR)

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 9, 2019Actual

Primary Completion Date

Feb 12, 2020Actual

Completion Date

Feb 12, 2020Actual

First Submitted Date

Jul 9, 2019

First Submission Date that Met QC Criteria

Jul 9, 2019

First Posted Date

Jul 11, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 22, 2021

Last Update Posted Date

Sep 28, 2021Actual

Name	Class
Emergent Clinical Consulting, LLC	INDUSTRY

Description Module

Brief Summary

To evaluate the safety, and efficacy of the ASR device for the temporary improvement in the appearance of a keloids.

Detailed Description

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

9Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ASR Treatment	Experimental	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)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Soliton's Acoustic Scar Reduction (SAR)	Device	Treatment of keloid scars for the temporary improvement in appearance.	ASR Treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	12 weeks

Secondary Outcomes

Measure	Description	Time Frame
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.	12 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or female older than 18 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 keloid that is easily delineated photographically located on the chest, back, trunk or upper arms and legs.
Keloid size greater than 1 cm and less than 8 cm in length, with a height of at least 2 mm.
Keloids less than 5 years old
Body Mass Index (B.M.I.) is > 20
Participant is willing to not undergo any other keloid treatments for a period of 12 months following ASR treatment.
Participant is willing to participate in study and adhere to follow-up schedule.
Participant is able to read and comprehend English or Spanish.
Participant has completed the Informed Consent Form.

Exclusion Criteria:

Participant had treatments, including topical steroids, to the keloid 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 ASR 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, elbows, knees, 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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D003095	Collagen Diseases
D003240	Connective Tissue Diseases
D017437	Skin and Connective Tissue Diseases
D002921	Cicatrix