Persons Seeking Tattoo RemovalNCT07759076
Evaluation of Automated Laser-Assisted Tattoo Removal: a Prospective Feasibility Clinical Study
A study testing PiRAT 1.0, tattoo removal laser in people with Persons Seeking Tattoo Removal, run by Raylution AG at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 84 yearsHealthy volunteers can take part
- Conditions the study is for
- Persons Seeking Tattoo Removal
- What is being tested?
- PiRAT 1.0, tattoo removal laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Sep 2026to 30 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 84 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site
Re.Naissance
Basel, Canton of Basel-City, 4056
Marc Theissing, +41 76 488 7519, info@tattoorenaissance.ch
About this study
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
- Persons Seeking Tattoo Removal
- Being tested
- PiRAT 1.0, tattoo removal laser
- Keywords
- Tattoo removal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PiRAT 1.0, tattoo removal laserDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Tattoo and Permanent Make-Up Removal | Experimental | Not described Receives: Device: PiRAT 1.0, tattoo removal laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
•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
Measured: 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
Measured: Directly after treatment
• Yes /No for laser path assessment (whether it was erratic or not)
Measured: Directly after treatment
• # for number of unintended interruptions
Measured: Directly after treatment
Secondary outcomes (6)
• Time required in minutes
Measured: Directly after treatment
• Visual Analogue Scale (VAS, 0-10 with 0 meaning no pain and 10 meaning worst possible pain) for assessing pain score
Measured: 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
Measured: 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
Measured: Directly after treatment
• Collection of data on Adverse Events
Measured: Up to 30 days after treatment
• Collection of data on Device Deficiencies
Measured: At the time of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Persons Seeking Tattoo RemovalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Raylution AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07759076
- Sponsor's protocol ID
- CI_PiRAT1.0
- Status last verified
- Aug 2026
- First submitted
- 10 Feb 2026
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Automated Laser-Assisted Tattoo Removal: a Prospective Feasibility Clinical Study
- ClinicalTrials.gov ID
- NCT07759076
- Acronym / sponsor ID
- CI_PiRAT1.0
- Conditions
- Persons Seeking Tattoo Removal
- Keywords
- Tattoo removal
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Raylution AGIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 11 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tattoo and Permanent Make-Up Removal | Experimental | Device: PiRAT 1.0, tattoo removal laser |
Who may qualify
- Ages
- 18 to 84 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PiRAT 1.0, tattoo removal laserThe 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 | Device | Tattoo and Permanent Make-Up Removal |
Primary outcome
•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
6 secondary outcomes
• 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PiRAT 1.0, tattoo removal laser in people with Persons Seeking Tattoo Removal, run by Raylution AG at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cyrill Bätscher (+41792902409, cyrill.baetscher@raylution.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
•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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.