Evaluation of Automated Laser-Assisted Tattoo Removal: a Prospective Feasibility Clinical Study

NCT07759076 | Not Yet Recruiting

• 1 other identifier: CI_PiRAT1.0
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Only Healthy Participants Are Included in the Study; Persons Seeking Tattoo Removal

Keywords

Tattoo removal; Dermatologic laser; Permanent Make-Up removal; Benign epidermal pigment removal; Robot; Nd:YAG; Alexandrite

Outcome Measures

Primary Outcomes (4)

• •VAS for defining target region, region of therapy, clarity and degree of completion of projection of region of therapy on patient skin

  Directly after treatment

• •VAS for usefulness of indication of size of region of therapy

  Directly after treatment

• • Y/N for laser path assessment

  Directly after treatment

• • # for number of unintended interruptions

  Directly after treatment

Secondary Outcomes (6)

• • Time required in minutes

  Directly after treatment

• • VAS for assessing pain score

  Directly after treatment

• • VAS for assessing ease of communication through user interface

  Directly after treatment

• • VAS for assessing overall user and patient satisfaction

  Directly after treatment

• • Collection of data on Adverse Events

  Up to 30 days after treatment

Study Arms (1)

Tattoo and Permanent Make-Up Removal

EXPERIMENTAL

Device: PiRAT 1.0, tattoo removal laser

Interventions

PiRAT 1.0, tattoo removal laser DEVICE

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

Tattoo and Permanent Make-Up Removal

Eligibility Criteria

• Age: 18 Years - 84 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Raylution AG: lead

Study Sites (1)

Re.Naissance

Basel, Canton of Basel-City, 4056, Switzerland

Location

Central Study Contacts

Cyrill Bätscher

CONTACT

+41792902409; cyrill.baetscher@raylution.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2026
• First Posted: August 11, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: August 11, 2026

Record last verified: 2026-08

Locations

CH (1)