NCT01516034

The Efficacy of the Cupola Ultrasonic Tattoo Removal Device

The Efficacy of the Cupola Ultrasonic Tattoo Removal Device: A Prospective Single Blinded, Before-After Study Design

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Cupola Medical Ltd · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

The study is designed to determine the efficacy of the Cupola tattoo removal device for tattoo removal.

Detailed description

The Cupola system is a non-invasive device for pigment/tattoo removal based on ultrasound technology. The safety of the device was demonstrated in a previous pilot study approved by the Herzog Helsinki committee #167-09, Ministry of Health April 2010 #HT-5293) showing that no risk was associated with the procedure. This study is designed to determine the efficacy of the device for tattoo removal in up to 6 treatments in different treatment intervals. Three areas of the tattoo that are similar in size, color, and intensity will be chosen. One area will not be treated; the second will receive 6 treatments in 2-3 week intervals; the third will receive 3 treatments in 4-6 week intervals. The evaluations will include color measurements, photography, subject comfort and skin condition.

Conditions

• Tattooing

Interventions

Type	Name	Description
DEVICE	Cupola Tattoo Removal device	Up to 6 treatments with the device every 2-3 weeks to the tattoo area.

Timeline

• Start date: 2011-11-01
• Primary completion: 2012-11-01
• Completion: 2012-11-01
• First posted: 2012-01-24
• Last updated: 2012-12-21
• Results posted: 2012-12-21

Locations

1 site across 1 country: Israel