Status:
UNKNOWN
A Prospective, Open Label, Non Randomized, Clinical Study to Evaluate the Safety and Effectiveness of the Eraser Tattoo Removal Device
Lead Sponsor:
Assaf-Harofeh Medical Center
Conditions:
Removal of Colors Tattoo (Multiple Colors)
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Name of Device: Eraser Tattoo Removal Device Device Description: The Eraser device is a mechanical device, resembling tattoo devices but with an innovative mechanism for dripping treatment fluid over...
Eligibility Criteria
Inclusion
- Male or female subjects 18 years or older, of any race.
- Subject has a tattoo for removal on the back, shoulders or abdomen (areas that can usually be hidden).
- Subjects willing to participate as evidenced by signing the written informed consent.
Exclusion
- Subject has a dermatological disease, active or latent (e.g. psoriasis)
- Subject has a known tendency for Keloid formation.
- Subject has a known tendency for skin hyperpigmentation.
- Subject is susceptible to Koebner reaction.
- Subject has blood transmittable diseases (HIV, HBV, HCV, etc.)
- Subject has known allergy to device components/ treatment fluids (stainless steel for needles; salicylic acid; aspirin; K-Y gel).
- Subject has medical conditions that may be worsened by concomitant use of aspirin (Hematologic, renal, GI, hepatic or gastrointestinal contraindications; viral illness or fever; old age increases susceptibility to toxic effects); topical salicylic acid (condylomata acumynata, open wounds, burns, diabetes mellitus, peripheral vascular disease, skin and skin structure infections, skin inflammation, skin irritation) or worsened by local anesthesia materials.
- Subject is taking aspirin or anti-coagulant medications; or using topical salicylic acid preparations.
- Female subject who is pregnant or lactating.
- Subject participates in any other clinical study at the same time
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2010
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00904631
Start Date
May 1 2009
End Date
August 1 2010
Last Update
May 20 2009
Active Locations (1)
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1
Assaf-Harofeh Medical Center
Ẕerifin, Israel, 70300