Study of new acoustic wave device as an accessory to laser treatment in tattoo reduction.
Device: planar acoustic wave device
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Full eligibility criteria for NCT02877667
Ages eligible for Study
22 Years to 65 Years
Genders eligible for Study
Accepts Healthy Volunteers
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.
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.).
All locations for NCT02877667
United States (1)
Chestnut Hill, Massachusetts, United States, 02467
View full eligibility
Tris trial is registered with FDA with number: NCT02877667. The sponsor of the trial is Soliton and it is looking for 40 volunteers for the current phase.
Official trial title: Soliton Planar Acoustic Wave Device System for Dermal Clearing Human Trial Protocol
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