Clinical Study to Evaluate the Performance of the PicoWayTM 1064 nm/ 785 nm/ 532nm Picosecond Laser for Tattoo Removal
NCT02700932 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15
Last updated 2017-04-04
Summary
This is an open-label, multi-center study. Subjects in this study will receive up to eight (8) treatments in 11±5 weeks (6-16 weeks) interval, with the PicoWayTM device using the 1064 nm/ 785±20 nm/ 532 nm handpiece according to the study protocol (tattoo colors). Subjects will return for one follow-up (FU) visit at the clinic at 8 weeks following the last treatment.
Methodology described in the protocol to evaluate efficacy and safety of treatments will be carried out at each visit at the clinic
Conditions
- Tattoo; Pigmentation
Interventions
- DEVICE
-
PicoWay
solid state laser capable of delivering energy at wavelengths of 1064 nm or 532 nm or wave length of 785±20 nm that was added to the system
Sponsors & Collaborators
-
Syneron Medical
lead INDUSTRY
Principal Investigators
-
Eric F Bernstein, MD · Main Line Center for Laser Surgery
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2016-01-20
- Primary Completion
- 2017-09-30
- Completion
- 2017-12-31
Countries
- United States
Study Locations
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