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| Name | Class |
|---|---|
| MedSource LLC | OTHER |
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To further evaluate accelerated fading resulting from additional treatment sessions of Soliton AWD as accessory to laser in tattoo reduction treatment.
To further evaluate accelerated fading resulting from additional treatment sessions of multi-pass Q-Switched laser with the Soliton Planar Acoustic Wave Device System (AWD) as an accessory to Q-Switched laser in tattoo reduction treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tattoos previously treated in Soliton 2016-001 trial | Other | Identical tattoos treated by Laser + AWD in Soliton's previous trial |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Soliton Acoustic Wave Device | Device | Treatment of tattoos with Soliton Acoustic Wave Device as an accessory to laser |
|
| Measure | Description | Time Frame |
|---|---|---|
| Tattoo clearance | To evaluate changes in accelerated fading of previously treated tattoos from original treatment with additional treatment sessions of Soliton Acoustic Wave Device as an accessory to laser treatment through comparison of photographic evidence. Changes are measured by comparing photos of the tattoos after the original treatment to photos of the tattoos after additional treatment. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment Emergent Adverse Events for Safety Reporting | Adverse Events and complications evaluated for severity and device relationship | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christopher Cappelli, MD | Soliton | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SkinCare Physicians | Chestnut Hill | Massachusetts | 02467 | United States |
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Single Group
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