Evaluation of Safety and Efficacy of TriPollar Device for... | NCT01858415

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

NCT01858415

Sponsor

Pollogen

Status

Unknown status

Last Update Posted

Aug 13, 2013Estimated

Enrollment

40Estimated

Phase

Not Applicable

Conditions

Facial Wrinkles

Interventions

TriPollar

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2013

Primary Completion Date

Dec 2013Estimated

Completion Date

Not provided

First Submitted Date

Apr 21, 2013

First Submission Date that Met QC Criteria

May 20, 2013

First Posted Date

May 21, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 11, 2013

Last Update Posted Date

Aug 13, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Label	Type	Description	Intervention Names
Single arm	Experimental		Device: TriPollar

Name	Type	Description	Arm Group Labels	Other Names
TriPollar	Device		Single arm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety of TriPollar	Safety will be established by physician's assessment/observation of adverse events.	6 months
Efficacy of TriPollar	Efficacy will be established by level of wrinkle reduction at 3 m fu based on photos evaluation by independent physicians.	6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

35 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mira Barki, PhD	Pollogen	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ronald L Moy, Inc.		Beverly Hills	California	90210	United States
Reaserch Across America

Type	Date	Date Unknown
Release	Jun 12, 2014
Reset	Jul 11, 2014