Prospective Clinical Study To Assess The Safety And Efficacy Of A Radiofrequency Diathermocontraction Device For Muscle Stimulation And The Treatment Of Abdominal Fat
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Muscle Stimulation
- Sponsor
- Cynosure, Inc.
- Enrollment
- 16
- Locations
- 1
- Primary Endpoint
- Number of Subjects Satisfied
- Status
- Terminated
- Last Updated
- 2 years ago
Overview
Brief Summary
The intended use of the device in this study to assess the safety and efficacy of the adhesive electrodes for muscle stimulation and the treatment of abdominal fat on the abdomen and/or flanks.
Detailed Description
Subjects are to be enrolled in this clinical study if they are a healthy male or female 18 years of age or older. Up to 30 subjects will be enrolled at 1 study center. Subjects will be enrolled into 2 groups, Group A and Group B. Subjects will be enrolled in Group A if they present with abdominal fat and are able to be present for all visits as outlined in "Schedule of Visits and Procedures - Group A". Subjects will enroll in Group B for training and experience purposes only and will follow the visit schedule as outlined in "Schedule of Visits and Procedures - Group B".
Investigators
Eligibility Criteria
Inclusion Criteria
- •A healthy male or female 18 years of age or older.
- •Agrees to be treated with the Brera/Med 400 device.
- •Understands and accepts obligation not to receive any other procedures on the treatment area through the length of the study.
- •Understands and accepts the obligation and is logistically able to be present for all visits.
- •Is willing to comply with all requirements of the study and sign the informed consent document.
Exclusion Criteria
- •Is pregnant or of childbearing potential and not using medically effective birth control, or has been pregnant in the last 3 months, currently breast feeding or planning a pregnancy during the study.
- •Is currently enrolled in an investigational drug or device trial, or has received an investigational drug or been treated with an investigational device within in the area to be treated 6 months (or at the discretion of the Investigator) prior to entering this study.
- •Has injured (such as a cut, wound) or infected skin, or has presence of evident pathologies such as melanomas or other tumors of the skin, dermatitis, eczema, psoriasis, etc. in the area to be treated.
- •Is on local, oral, or systemic anesthetic agents.
- •Has nerve insensitivity to heat in the treatment area.
- •Has received an organ transplant.
- •Has any embedded electronic device that gives or receives a signal, the device should be turned off or removed prior to treatment.
- •Has an embedded pacemaker or implantable cardioverter defibrillator (ICD), the client's cardiologist must be consulted prior to treatment.
- •NOTE: This device has not been tested on patients implanted with electronic devices that receive or emit signals, such as: Pacemakers, Implantable Cardiac Defibrillators (ICD), or Cardiac Resynchronization Therapy (CRT) devices.
- •If the neutral pad would need to be placed on a subject that has a metal plate, rod, or any metal implant that could conduct heat.
Outcomes
Primary Outcomes
Number of Subjects Satisfied
Time Frame: 30 days follow up.
The number of subjects satisfied with their treatment will be reported.