Abdominal Fat, Muscle Stimulation
Conditions
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.
Interventions
DEVICEBrera
The applicators will be placed in contact with the skin. The entire defined treatment area will then be treated by delivering energy to the skin. Temperature may be continuously monitored and recorded during treatment. Parameters may be adjusted throughout the treatment to increase subject comfort.
Sponsors
Cynosure, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Subjects will be enrolled in Group A if they present with abdominal fat and are able to be present for up to 8 treatment visits spaced approximately 1 week apart. Subjects will enroll in Group B for training and experience purposes only and will be able to attend up to 8 treatments spaced at least 3 days apart.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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. * Has an allergy to adhesives, such as glues on medical tape, they should be alerted that a rash may occur on the applicator and neutral pad site, and an over-the-counter solution may be used to treat the area. * Has an unhealthy expectation of the results - this is not plastic surgery and all subjects should be fully informed of the treatment's expected results. * Has severe laxity or sagging that causes redundant folds of tissue or hanging skin in the area to be treated - this treatment will be ineffective. * Has used Accutane (Isotretinoin) six to twelve months prior to treatment, as this can thin the skin and make it brittle. * Is currently taking anticoagulants. * The treatment area has scars and/or tattoos. * Has any of the following conditions: * Thrombosis or Thrombophlebitis * Active Vascular Disease * Labyrinthitis and Tinnitus * Liver Disease or Dyslipidemias * Acute Sepsis * Has any condition or is in a situation which in the investigators opinion may put the subject at significant risk, may confound study results or may interfere significantly with the subject's participation. Cautionary Criteria: • Has any of the following conditions: * Autoimmune Disease * Diabetic * Herpes Simplex
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Satisfied | 30 days follow up. | The number of subjects satisfied with their treatment will be reported. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group A Subjects in Group A will receive up to 8 treatments with the Brera/Med 400 device on their abdomen or flanks. Subjects may receive a phone call 1 week (1-7 days) after each treatment to record side effects. Subjects will return for follow up visits at 30 and 90 days post last treatment for efficacy and side effects assessments.
Brera: The applicators will be placed in contact with the skin. The entire defined treatment area will then be treated by delivering energy to the skin. Temperature may be continuously monitored and recorded during treatment. Parameters may be adjusted throughout the treatment to increase subject comfort. | 16 |
| Group B Subjects in Group B may receive up to 8 treatments with the Brera/Med 400 device on their abdomen and/or flanks. Subjects may receive a phone call 1 week (1-7 days) after each treatment to record side effects. Subjects may be asked return for follow up visits at 30 and 90 days post last treatment for efficacy and side effects assessments. Outcome measures will not be taken for subjects enrolled in this group.
Brera: The applicators will be placed in contact with the skin. The entire defined treatment area will then be treated by delivering energy to the skin. Temperature may be continuously monitored and recorded during treatment. Parameters may be adjusted throughout the treatment to increase subject comfort. | 0 |
| Total | 16 |
Baseline characteristics
| Characteristic | Group A | Group B | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 16 Participants | 0 Participants | 16 Participants |
| FitzPatrick Skin Type Fitzpatrick Skin Type I | 0 Participants | 0 Participants | 0 Participants |
| FitzPatrick Skin Type Fitzpatrick Skin Type II | 5 Participants | 0 Participants | 5 Participants |
| FitzPatrick Skin Type Fitzpatrick Skin Type III | 10 Participants | 0 Participants | 10 Participants |
| FitzPatrick Skin Type Fitzpatrick Skin Type IV | 1 Participants | 0 Participants | 1 Participants |
| FitzPatrick Skin Type Fitzpatrick Skin Type V | 0 Participants | 0 Participants | 0 Participants |
| FitzPatrick Skin Type Fitzpatrick Skin Type VI | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian/Indian | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Caucasian | 13 Participants | 0 Participants | 13 Participants |
| Race/Ethnicity, Customized Dominican/American | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Hispanic | 1 Participants | 0 Participants | 1 Participants |
| Sex: Female, Male Female | 14 Participants | 0 Participants | 14 Participants |
| Sex: Female, Male Male | 2 Participants | 0 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 16 | 0 / 0 |
| other Total, other adverse events | 13 / 16 | 0 / 0 |
| serious Total, serious adverse events | 0 / 16 | 0 / 0 |
Outcome results
Primary
Number of Subjects Satisfied
The number of subjects satisfied with their treatment will be reported.
Time frame: 30 days follow up.
Population: There were no subjects enrolled for Group B.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group A | Number of Subjects Satisfied | 10 number of participants satisfied |