Investigation of Radiofrequency Device for Treatment of W... | NCT01279226

Studies
Investigation of Radiofrequency Device for Treatment of Wrinkles and Rhytides

NCT01279226

Sponsor

Rocky Mountain Biosystems, Inc.

Status

Completed

Last Update Posted

Dec 3, 2012Estimated

Enrollment

40Actual

Phase

Not Applicable

Conditions

Laxity of Skin

Interventions

Auralevée device

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

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2010

Primary Completion Date

Feb 2011Actual

Completion Date

Feb 2011Actual

First Submitted Date

Jan 14, 2011

First Submission Date that Met QC Criteria

Jan 14, 2011

First Posted Date

Jan 19, 2011Estimated

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

Nov 30, 2012

Last Update Posted Date

Dec 3, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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 purpose of this pilot research study is to collect information on the safety and effectiveness of an experimental device intended to be used to improve the appearance of the skin by reducing the visibility of wrinkles and by reducing the looseness of skin.

Detailed Description

Not provided

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

40Actual

Name	Type	Description	Arm Group Labels	Other Names
Auralevée device	Device	Single treatment with Auralevée device.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Improved cosmesis	Photographs of subjects before and after treatment will be scored and compared. Histology of skin samples may be used to assess deleterious events and elucidate the operative mechanism.	2-6 timepoints from 4 days to 6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or female at least 21 years old,
Apparently healthy,
Informed consent signed by the subject.

Exclusion Criteria:

Tobacco smokers,
History of skin hypersensitivity,
Current skin disorder or infection (e.g., herpes simplex),
Prior cosmetic treatments to the face (e.g. Botox) or facial fillers (e.g. Restylane),
Subjects with a pacemakers, internal defibrillators or electronically, magnetically, and mechanically activated implants,
Subjects with implanted medical prostheses (such as clips, pins or plates) proximal to the treatment site,
The current or recent use (within the past 12 months) of isotretinoin,
Pregnancy or breast feeding,
Insulin dependent diabetic subjects,
Oxygen dependent subjects,
Subjects with severe chronic illness, scleroderma, or lupus,
Subjects with open sores or scars in the treatment region, or
Subjects with ischemia in the treatment region.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Peter Cooperrider, MD	Laser Treatment Center	Principal Investigator
Stephen Flock, PhD	Rocky Mountain Biosystems, Inc.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Laser Treatment Center		Kirkland	Washington	98034	United States