Study of Radiofrequency Device for Use in Non-Invasive Cosmetic Procedures
Radiofrequency Magnetic Induction Device for Use in Non-Invasive Body Contouring
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2010
CompletedFirst Submitted
Initial submission to the registry
January 7, 2011
CompletedFirst Posted
Study publicly available on registry
January 11, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2012
CompletedFebruary 9, 2012
February 1, 2012
8 months
January 7, 2011
February 8, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
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
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Center for Cosmetic Surgery
Golden, Colorado, 80401, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Andrew Wolfe, MD
Center for Cosmetic Surgery
- STUDY DIRECTOR
Stephen Flock, PhD
Rocky Mountain Biosystems, Inc.
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 7, 2011
First Posted
January 11, 2011
Study Start
December 1, 2010
Primary Completion
August 1, 2011
Study Completion
January 1, 2012
Last Updated
February 9, 2012
Record last verified: 2012-02