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Evaluation of Automated Laser-Assisted Tattoo Removal: a Prospective Feasibility Clinical Study
Sponsor: Raylution AG
Summary
The goal of this study is to collect preliminary clinical performance data focused on the usability aspects of the human - machine interaction, with focus on planning, navigation and application of automated laser tattoo removal. The study will enroll adult patients with monochrome dark tattoos. In addition to the data collected on the human-machine interaction, it will also collect other outcomes like pain during treatment, overall user and patient satisfaction, and adverse events. For the participants, treatment will follow standard procedures. In addition to this, they will be followed up after 30 days, to see if any complications occured.
Key Details
Gender
All
Age Range
18 Years - 84 Years
Study Type
INTERVENTIONAL
Enrollment
10
Start Date
2026-09-01
Completion Date
2026-11-30
Last Updated
2026-08-11
Healthy Volunteers
Yes
Interventions
PiRAT 1.0, tattoo removal laser
The investigational device, PiRAT, uses a standard laser, but with added automation which has the potential to perform the procedure more quickly and precisely, with less heat accumulation and less documentation required. observed, documented, and assessed in real-life circumstances.Documentation of patient / skin data
Locations (1)
Re.Naissance
Basel, Canton of Basel-City, Switzerland