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Evaluation of Safety and Efficacy of TriPollar Device for Treatment of Wrinkles

NCT ID: NCT01858415

Last Updated: 2013-08-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Brief Summary

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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

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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 the skin is intended to stimulate collagen remodeling in the dermal layer resulting in non invasive wrinkle treatment.

Conditions

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Facial Wrinkles

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Single arm

Group Type EXPERIMENTAL

TriPollar

Intervention Type DEVICE

Interventions

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TriPollar

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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 Criteria

* Listed in approved protocol, and ICF
Minimum Eligible Age

35 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pollogen

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mira Barki, PhD

Role: STUDY_DIRECTOR

Pollogen

Locations

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Ronald L Moy, Inc.

Beverly Hills, California, United States

Site Status

Reaserch Across America

Plano, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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PC210118_S, rev. 01

Identifier Type: -

Identifier Source: org_study_id