An interventional study of planar acoustic wave device in Tattoo, sponsored by Soliton. Completed at 1 site in United States. Open to participants aged 22 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-07-29.
Sponsored by Soliton · Not applicable, Interventional, and Treatment
Study of new acoustic wave device as an accessory to laser treatment in tattoo reduction.
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.
Soliton is the lead sponsor of 7 studies on the registry; none are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Up to four passes with Q-Switched laser alternating with acoustic wave device
Device: planar acoustic wave device
accessory to laser treatment
Also known as: AWD
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
Time frame: 1 day
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%
Time frame: 12 weeks
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.
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Soliton