Status:
UNKNOWN
Evaluation of Safety and Efficacy of TriPollar Device for Treatment of Wrinkles
Lead Sponsor:
Pollogen
Conditions:
Facial Wrinkles
Eligibility:
All Genders
35-65 years
Phase:
NA
Brief Summary
The TriPollar is intended for non invasive treatment of facial wrinkles and rhytides. This study was designed in order to evaluate the safety and efficacy of the TriPollar.
Detailed Description
The TriPollar technology is based on three or more electrodes designed to deliver RF current focused into the skin, thus generating heat in the dermal layer. Selective and focused electro-heating of t...
Eligibility Criteria
Inclusion
- Subject read, discussed and signed the Consent Form,
- Healthy female/male aged 35 65 years,
- Has facial wrinkles,
- Capable of reading, understanding and following instructions of the procedure to be applied,
- Able and willing to comply with the treatment and follow-up schedule.
Exclusion
- Listed in approved protocol, and ICF
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01858415
Start Date
April 1 2013
Last Update
August 13 2013
Active Locations (2)
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1
Ronald L Moy, Inc.
Beverly Hills, California, United States, 90210
2
Reaserch Across America
Plano, Texas, United States, 75093