Persons Seeking Tattoo Removal
Conditions
Keywords
Tattoo removal
Brief 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.
Interventions
DEVICEPiRAT 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
Sponsors
Raylution AG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 84 Years
Healthy volunteers
Yes
Inclusion criteria
* Adults (18 - 84 years) * Woman or man (for women in their reproductive age, a confirmation of a pregnancy test with negative result is mandatory) * Fitzpatrick skin types I-VI * Monochrome dark tattoo (black, dark grey, dark blue, dark green, dark red, puce) * Tattoo size ≤ A5 (311 cm2)
Exclusion criteria
* Patients with absolute or relative contraindications (according to IFU) * Pregnancy or breastfeeding * History of keloids or hypertrophic scarring * Active skin infections or conditions at the tattoo site * Use of photosensitizing medications
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| •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 | 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 | Directly after treatment |
| • Yes /No for laser path assessment (whether it was erratic or not) | Directly after treatment |
| • # for number of unintended interruptions | Directly after treatment |
Secondary
| Measure | Time frame |
|---|---|
| • Time required in minutes | Directly after treatment |
| • Visual Analogue Scale (VAS, 0-10 with 0 meaning no pain and 10 meaning worst possible pain) for assessing pain score | 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 | 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 | Directly after treatment |
| • Collection of data on Adverse Events | Up to 30 days after treatment |
| • Collection of data on Device Deficiencies | At the time of treatment |
Countries
Switzerland
Contacts
CONTACTCyrill Bätscher
Outcome results
None listed