Proven Results
CIRCUMFERENTIAL FAT REDUCTION WITH NON-INVASIVE EXTERNAL ULTRASOUND TREATMENT
Principle Investigator: Michael Kaminer, M.D.
ABSTRACT
Twelve (12) female subjects were enrolled at one site between December 16,2010 and March 01, 2011. Subjects were treated once in the infrascapular (“bra-line”) region with a non-invasive external ultrasound device. Circumferential measurements were made before and immediately after treatment, and also at two separate follow-up appointments (one week and 180 days) post initial treatment. This presentation will review the overall design of the study, materials and methods, and provide statistically significant clinical results and discussion.
BACKGROUND
Over recent years, increasing attention has been paid to non-invasive treatments for skin laxity and subcutaneous fat. The VASER Shape MC1™ System (Sound Surgical Technologies, Louisville, Colorado) is indicated for: temporary reduction in the appearance of cellulite, relief of minor aches and pains, and reduction of postoperative pain and swelling by temporarily improving local blood circulation under 510(k) number K091615. After one year of treating patients, some physicians have anecdotally noted a reduction in circumferential measurement post procedure with no associated adverse events. This pilot observational study was developed to determine if there is an associated reduction in circumferential measurement after use of the VASER Shape device. The study was designed to observe effects and measurements after one of the recommended five VASER Shape treatments on the infrascapular region. This region was chosen because its position on the torso makes measurement less reliant on patient posture and respiration.
MATERIALS AND METHODS
Non-Invasive Ultrasound Device
The VASER Shape MC1 System is a non-invasive technology for treatment of the human body that uses ultrasound waves to treat a variety of patient conditions.
The system uses a dual transducer head that emits a double beam of overlapping ultrasonic energy at a frequency of 1MHz. The ultrasound beams overlap and treats fatty tissue between 1cm and 5cm below the surface of the skin. The energy may also be modulated between 20 kHz and 60 kHz. Ultrasound energy passes through the skin on the way to the underlying fatty tissue layers. The total amount of energy applied to the skin can be controlled based on patient comfort.
The ultrasonic handpiece delivers energy on a continuous basis, like a continuous massage, and results in both acoustic thermal and acoustic mechanical effects. These mechanisms warm the treatment area and temporarily change the characteristics of the underlying tissue matrix. The operator acts with a continual motion, gently following the patient’s body contour, which improves patient interaction and also acts in concert with the lymphatic system.
The VASER Shape device also includes a separate Zonal handpiece that provides a lymphatic massage.
Overview
This was a non-randomized, open-label study of the VASER Shape device in up to twelve (12) human participants. Potential candidates provided consent and were screened by the study center. Each subject underwent an initial evaluation, including taking photographs and measurements of the area to be treated, as well as recording height, weight and subject history.
The subject was then treated under the direction of the Principal Investigator using the VASER Shape device. Photographs and measurements were taken immediately following the procedure, at one week post initial treatment (3 – 7 days), and again between 100 and 190 days after the initial treatment. Infrared imaging of the treated areas was also conducted to record the maximum skin temperatures achieved during the treatment session.
The original version of the study for ten (10) subjects was approved on December 09, 2010 by Liberty IRB. Subjects #001 and #002 were treated under this protocol. There were 2 revisions during this study.
Revision 1: This version increased the maximum number of subjects to twelve (12). This protocol added infrared imaging of the treated areas and recording of the maximum skin temperatures reported by the device. This version was approved on January 06, 2011. Subjects #003 through #010 were treated under this protocol and Subjects #004 through #010 completed follow-up under this protocol.
Revision 2: This version added a longer term follow-up for measurements and photographs. This version was approved on June 02, 2011. Subjects #001, #002, #004, #005, #006, #007, #008 and #009 consented to be followed under this protocol.
Patient Preparation and Treatment
Prior to treatment, the region of interest was circumferentially measured and photographed. The VASER Shape ultrasonic treatment may be conducted in one of two modes: Continuous or Modulated.
In the Continuous Mode, the ultrasonic energy is delivered at a constant rate. The user can program the power delivered. In this mode, the majority of the ultrasonic energy is delivered superficially and primarily affects the upper layers of tissue. In Modulated Mode, the ultrasonic energy is modulated at a programmable frequency between 20 kHz and 60 kHz. The modulation of the ultrasonic energy varies the depth at which the majority of the energy is delivered. The ultrasound energy is typically applied for 30 minutes per area and/or treatment side.
Following the ultrasound treatment, the Zonal Handpiece is utilized to facilitate lymphatic drainage of the area treated. Each area is treated for approximately three to six minutes.
After completion of the full treatment (ultrasound and lymphatic massage), the region of interest was re-measured circumferentially and re-photographed. The patients were then allowed to proceed with their regular schedule with no required recovery period.
RESULTS
Circumferential Changes
Subjects were measured before treatment to establish a baseline, post-treatment and then again at follow-up. Eight (8) subjects completed followup with all measurements obtained. The mean circumferential measurements were 87.3 cm, 86.4 cm, 86.2 cm and 85.2 cm at baseline, post-treatment and at short and long term follow-up respectively. Mean circumferential changes were found to be -0.88 cm post-treatment, and -1.14 cm & -2.08 cm at follow-up. One subject, #001, had, during the intervening period between the one week and long term follow-up, undergone additional procedures for body contouring, losing 30 pounds of weight. If we remove this subject from the analysis, the mean circumferential reduction at long term follow-up was -0.90 cm. Long term follow-up occurred at a mean of 132 days after treatment (range 111 – 190 days).
Two-sided paired t-tests were performed comparing post-treatment and follow-up to baseline after confirmatory tests for normality. Circumferential changes were found to be statistically significant immediately and at one week with p=0.011 and 0.022 respectively. This result indicates that the cohort experienced change following the treatment and that the change was sustained through follow-up. Paired tests for long term follow-up did not reach significance. Table 1 shows the individual measurements and changes per subject. The mean changes over time are shown in Figure 1.
Subject Treatments
Subjects were treated with ultrasound for a mean duration of 30 minutes per side, with six minutes of zonal massage following. All treatments were performed using the maximum power settings. There was no significant correlation between treatment time and circumferential measurement change at follow-up. The mean temperature achieved during treatments was 46.5° C. The subjects experienced greater circumferential reduction results at higher treatment temperatures as shown in in Figure 2.
DISCUSSION AND CONCLUSION
The VASER Shape MC1 System was shown to provide an average circumferential reduction of over 1 cm after one treatment in nine subjects. After a mean of 132 days, the average circumferential reduction in subjects without any further procedures was 0.9 cm.
The application of ultrasound was very well tolerated with a high degree of clinical safety. There were no significant adverse events. The lack of these types of events demonstrates that the heat generated by the system does not harm the patient and that the ultrasonic energy does not damage or rupture blood vessels under the skin. There were no disturbances or disruptions of sensation reported in patients treated with the VASER Shape device.
Although it does not provide the dramatic reduction of liposuction, VASER Shape may be considered for patients with small, localized areas of fat or for any patient who does not wish to have invasive procedures performed. The circumferential reductions observed with the device are similar to other non-invasive modalities with superior ease-of-use, immediate results, no patient discomfort and a low incidence of adverse events.
Only one treatment of the recommended five (5) was conducted in order to assess safety, as well as to observe, under a controlled setting, the results that have been experienced by other physicians. After only one treatment, efficacy was greater than expected and it is hypothesized that five (5) treatments should show further reductions while maintaining safety. Future clinical and pre-clinical studies will provide greater insight into the mechanism of action of this new technique and better guide patient selection and treatment parameters.
