Histological Study to Assess Safety and Efficacy of the TempSure Firm for Non-invasive Lipolysis
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Body Fat
- Sponsor
- Cynosure, Inc.
- Enrollment
- 12
- Locations
- 2
- Primary Endpoint
- Histology of Biopsy
- Status
- Terminated
- Last Updated
- 2 years ago
Overview
Brief Summary
This is a prospective, controlled, multi-center study. Patients will be enrolled and treated with a radiofrequency device in this study if they have unwanted fat in the abdominal area.
Detailed Description
Subjects are to be enrolled in this clinical study if they are 18 - 55 years old and are willing to have biopsies taken from a control site and the treatment area. Subjects may be enrolled if they have been previously scheduled or willing to have an abdominoplasty procedure after their participation in the study. A maximum of 20 subjects will be enrolled at up to 4 study centers. Subjects will attend a screening/pretreatment visit which may be performed on the same day as the treatment visit. Subjects may receive up to 5 treatments with the TempSure® Firm on the abdomen or flanks. All subjects will receive a phone call 1 week (1-10 days) post each treatment. Subjects may be asked to return for follow-up visits after their final treatment for incisional biopsies. A follow up may occur at 10, 20, and/or 30 days post their last treatment.
Investigators
Eligibility Criteria
Inclusion Criteria
- •A healthy male or female between the age of 18 - 55 years old.
- •Willing to receive treatments with the TempSure device and are willing to have biopsies taken from a control site and the treatment area.
- •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.
- •The subject 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 prior to entering this study.
- •The subject has a cut, wound, or infected skin on the area to be treated.
- •The subject is on local, oral, or systemic anesthetic agents.
- •The subject 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.
- •The subject 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.
- •Cautionary Criteria:
- •The subject has any embedded electronic device that gives or receives a signal, the device should be turned off or removed prior to treatment.
- •The subject 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.
Outcomes
Primary Outcomes
Histology of Biopsy
Time Frame: Up to 30 days post last treatment
Samples will be assessed independently and may be assessed for normal structures, cell viability, vascular injury, and overall morphologic traits, injury, and any indications of the healing response.