NCT02891239

785nm Picosecond Laser for Treatment of Benign Pigmented Lesions

Clinical Study to Evaluate the Performance of the PicoWay 1064 nm/ 785 nm/ 532nm Picosecond Laser for Treatment of Benign Pigmented Lesions

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Syneron Medical · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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 PicoWay device using the 785 nm wavelength alone or combined with 1064 nm or 532 nm wavelengths. Subjects will return for one follow-up (FU) visit at the clinic at 8 weeks following the last treatment.

Detailed description

This study is a prospective clinical study to demonstrate the safety and efficacy of the PicoWay device for benign pigmented lesion treatment. Up to a total of 60 healthy candidates, who are seeking treatment/clearance of benign pigmented lesions, will be enrolled at up to 3 participating study sites. Subjects will receive up to eight (8) PicoWay treatments at 11±5 (6-16) week's intervals. Prior to each consecutive treatment, the investigator will decide, based on degree of clearance assessment, should the subject undergo additional treatment or proceed to the 8-weeks follow-up (FU) visit with no more treatments.

Conditions

• Benign Pigmented Lesions

Interventions

Type	Name	Description
DEVICE	PicoWay	solid state laser capable of delivering energy at wavelengths of 1064 nm or 532 nm or wavelength of 785 nm that was added to the system

Timeline

• Start date: 2016-09-01
• Primary completion: 2017-09-01
• Completion: 2017-09-01
• First posted: 2016-09-07
• Last updated: 2016-09-14

Locations

1 site across 1 country: United States