Soliton Planar Acoustic Wave Device System for Dermal Clearing Human Trial Protocol
NCT ID: NCT02877667
Last Updated: 2020-07-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2016-07-31
2017-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Open label device treatment
Up to four passes with Q-Switched laser alternating with acoustic wave device
planar acoustic wave device
accessory to laser treatment
Interventions
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planar acoustic wave device
accessory to laser treatment
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.).
22 Years
65 Years
ALL
Yes
Sponsors
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MedSource LLC
OTHER
Soliton
INDUSTRY
Responsible Party
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Principal Investigators
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Chris Capelli, MD
Role: STUDY_DIRECTOR
Soliton
Locations
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SkinCare Physicians
Chestnut Hill, Massachusetts, United States
Countries
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Other Identifiers
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Soliton 2016-001
Identifier Type: -
Identifier Source: org_study_id
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