Study of Radiofrequency Device for Use in Non-Invasive Co... | NCT01273961

Studies
Study of Radiofrequency Device for Use in Non-Invasive Cosmetic Procedures

NCT01273961

Sponsor

Rocky Mountain Biosystems, Inc.

Status

Completed

Last Update Posted

Feb 9, 2012Estimated

Enrollment

20Actual

Phase

Not Applicable

Conditions

Laxity of Skin

Interventions

AuraLevée treatment

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

Feb 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

Dec 2010

Primary Completion Date

Aug 2011Actual

Completion Date

Jan 2012Actual

First Submitted Date

Jan 7, 2011

First Submission Date that Met QC Criteria

Jan 7, 2011

First Posted Date

Jan 11, 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

Feb 8, 2012

Last Update Posted Date

Feb 9, 2012Estimated

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 purpose of this pilot research study is to collect information on the safety and effectiveness of an experimental device used to treat and 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

20Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
AuraLevée treatment	Device	A single treatment, on day 0, on each of no more than two treatment sites, using the AuraLevée device. Treatment sites are the face, abdomen, upper arm, thigh or neck.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Improvement in cosmesis	Improvement in cosmesis will be assessed by scoring photographs taken before and 1 and 3 months after treatment. Circumference changes will be measured and compared.	1 and 3 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or female 21 to 70 years old,
For females, at least 9 months post-partum,
Clinically appreciable skin laxity on the abdomen, thigh, upper arms or neck as determined by the study investigator,
For females, post-menopausal, surgically sterilized, or using a medically accepted form of birth control for at least 3 months prior to the study,
Apparently healthy,
Informed consent signed by the subject.

Exclusion Criteria:

History of skin hypersensitivity,
Current skin disorder (e.g. keloid scarring) or infection (e.g., herpes simplex),
Use of non-steroidal anti-inflammatory drugs within past 2 weeks,
Suffering from hormonal imbalance which may affect weight or cellulite,
Subjects with 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,
Infectious diseases (such as HIV) present,
Are a tobacco smoker,
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

70 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
Andrew Wolfe, MD	Center for Cosmetic Surgery	Principal Investigator
Stephen Flock, PhD	Rocky Mountain Biosystems, Inc.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Center for Cosmetic Surgery		Golden	Colorado	80401	United States