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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
10
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
Re.Naissance
Basel, Canton of Basel-City, Switzerland
•Visual Analogue Scale (VAS, 0-10 with 0 meaning it was impossible to use and 10 meaning it was very simple to use) for defining target region, region of therapy, clarity and degree of completion of projection of region of therapy on patient skin
Time frame: Directly after treatment
•Visual Analogue Scale (VAS, 0-10 with 0 meaning it was impossible to use and 10 meaning it was very simple to use) for usefulness of indication of size of region of therapy
Time frame: Directly after treatment
• Yes /No for laser path assessment (whether it was erratic or not)
Time frame: Directly after treatment
• # for number of unintended interruptions
Time frame: Directly after treatment
• Time required in minutes
Time frame: Directly after treatment
• Visual Analogue Scale (VAS, 0-10 with 0 meaning no pain and 10 meaning worst possible pain) for assessing pain score
Time frame: Directly after treatment
• Visual Analogue Scale (VAS, 0-10 with 0 meaning it was very easy to communicate with the device and 10 meaning it was very complicated to communicate with the device) for assessing ease of communication through user interface
Time frame: Directly after treatment
•Visual Analogue Scale (VAS, 0-10 with 0 meaning very satisfied with the treatment and 10 meaning very unsatisfied with the treatment) for assessing overall user and patient satisfaction
Time frame: Directly after treatment
• Collection of data on Adverse Events
Time frame: Up to 30 days after treatment
• Collection of data on Device Deficiencies
Time frame: At the time of treatment
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