Evaluation of Automated Laser-Assisted Tattoo Removal: a Prospective Feasibility Clinical Study
NCT07759076 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10
Last updated 2026-08-11
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.
Conditions
- Only Healthy Participants Are Included in the Study
- Persons Seeking Tattoo Removal
Interventions
- DEVICE
-
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
Sponsors & Collaborators
-
Raylution AG
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- DEVICE_FEASIBILITY
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 84 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2026-09-01
- Primary Completion
- 2026-11-30
- Completion
- 2026-11-30
Countries
- Switzerland
Study Locations
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