Soliton Planar Acoustic Wave Device System for Dermal Cle... | NCT02877667

Studies
Soliton Planar Acoustic Wave Device System for Dermal Clearing Human Trial Protocol

NCT02877667

Sponsor

Soliton

Status

Completed

Last Update Posted

Jul 29, 2020Actual

Enrollment

40Actual

Phase

Not Applicable

Conditions

Tattoo

Interventions

planar acoustic wave device

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

Jul 2020

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 2016

Primary Completion Date

Apr 19, 2017Actual

Completion Date

Apr 30, 2017Actual

First Submitted Date

Aug 19, 2016

First Submission Date that Met QC Criteria

Aug 23, 2016

First Posted Date

Aug 24, 2016Estimated

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

Jul 27, 2020

Last Update Posted Date

Jul 29, 2020Actual

Name	Class
MedSource LLC	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Study of new acoustic wave device as an accessory to laser treatment in tattoo reduction.

Detailed Description

A non-significant risk, single center, prospective device trial to evaluate the number of passes of Q-Switch laser treatment that can be completed with a Q-Switch Laser alone compared to use of the Soliton Planar Acoustic Wave Device System (AWD) System as an accessory to Q-switched laser in tattoo reduction 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

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Open label device treatment	Experimental	Up to four passes with Q-Switched laser alternating with acoustic wave device	Device: planar acoustic wave device

Interventions

Name	Type	Description	Arm Group Labels	Other Names
planar acoustic wave device	Device	accessory to laser treatment	Open label device treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Demonstrate that multiple passes with Quality Switched Yag laser is safe based on assessment of Adverse Events	Safety assessments included reported Adverse Events as a result of physician examination	1 day

Secondary Outcomes

Measure	Description	Time Frame
Efficacy comparison of tattoo fading of laser versus laser and Acoustic Wave Device treated tattoos .	The degree of fading assessed in terms of percentage fading (1-100%) and according to the following 1 to 5 scale: 1 = 0%; 2 = 1-25%; 3 = 26-49%; 4 = 50-75%; or 5 = 76-100%	12 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Range of Fitzpatrick skin color scores I to III
Tattoo with location on arms, legs, and torso only, and accessible to AWD treatment head. Black ink only. Other ink colors may be present, but areas of black only tattoo should meet criteria described as: minimum 1" x 3" tattoo with at least 30-50% consistent coverage (see fig 1).
Tattoo age between 1 and 20 years.
Professionally applied.

Exclusion Criteria:

Subject is pregnant or planning to become pregnant during the duration of the study.
Prior tattoo removal procedures on target tattoo.
Self-applied or amateur tattoo.
Tattoo layering (additional tattoo placed over an older tattoo to hide it) on target tattoo.
Metal or plastic implants in the area of the tattoo (pacemaker, implanted defibrillator, stent, or implants in the hips, knees, elbows, etc.).

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

22 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Chris Capelli, MD	Soliton	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
SkinCare Physicians		Chestnut Hill	Massachusetts	02467	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided