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

Study Overview
=================
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.

Official Title
-----------------
Soliton Planar Acoustic Wave Device System for Dermal Clearing Human Trial Protocol

Conditions
-----------------
Tattoo

Intervention / Treatment
-----------------
* Device: planar acoustic wave device


Participation Criteria
=================
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.).

Ages Eligible for Study
-----------------
Minimum Age: 22 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Open label device treatment<br>Up to four passes with Q-Switched laser alternating with acoustic wave device | Device: planar acoustic wave device<br>* accessory to laser treatment<br>* Other names: AWD;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
tattoo, laser