A Study to Evaluate the Benefits of Harmonic Vibration Liposuction

Liposuction is a cosmetic surgical procedure, which removes unwanted areas of subcutaneous fat using a small stainless steel suction cannula connected to a strong vacuum by plastic tubing. The cannula is inserted into subcutaneous fat through tiny incisions, which eventually become imperceptible. When a strong suction is applied and the cannula is moved in a reciprocating in-an-out motion, subcutaneous fat is aspirated into a disposable canister. Harvesting with the standard liposuction, or even the more efficient reciprocating PAL device, consists of plowing back and forth through the same narrow axial channel in one dimension. This tends to over harvest from that one groove and the resultant unevenness is the cause of most liposuction complications. In contrast, with each stroke, a harmonically vibrating cannula harvests from a wider three-dimensional volume of tissue. The result is like fishing with a spear compared to throwing a net, or hunting birds with a rifle instead of a shotgun. According to the American Society of Plastic Surgeons (ASPS), liposuction is performed in over 258,000 procedures in 2018. Liposuction can be performed on the hips and buttocks, upper arms, abdomen and waist, thighs, back and chest. Although liposuction is a safe procedure when it is performed properly, some complications, such as skin irregularities, extended edema, changes to skin sensitivity, seromas, fat embolism, sepsis may occur. One of the major issues with the current procedure is liposuction deformity complications. Initial research using a prototype Harmonic Harvester in more than 100 procedures, demonstrated that much less post liposuction contour deformities were observed; and no complications attributable to the liposuction were reported. In addition, the harvesting is much more efficient (more volume of fat harvested per minute of liposuction); the harvested fat seems to be better grafting material, probably richer in stem cells, as our grafting results have improved. A liposuction cannula harmonically vibrating (HV) between 30 and 80Hz is most efficient at harvesting fat. Furthermore, we also hypothesize that compared to the standard liposuction or the power assisted liposuction (PAL), HV harvests better quality fat with less contour deformity complications. The primary objective is to evaluate the merits of the liposuction cannula harmonically vibrating in liposuction compared to the PAL assisted liposuction. The study is designed as a prospective, multicenter, crossover study. Each patient will have symmetric areas liposuctioned by HV on one side of the body and PAL assisted liposuction on the other side. The subjects will be blinded to study treatment for the duration of the study period. A total of 12 subjects at up to 2 investigative sites will be enrolled and equally (1:1) randomized between those undergoing HV vs. those treated using PAL assisted liposuction. Overall study duration (first subject enrolled through last subject exit) will be comprised of approximately 1 - 2 weeks of enrollment period. Study duration for an individual subject, once consented, will be 30 days for follow-up after treatment. Primary Safety Endpoints Endpoint: Acute success Description: Freedom from procedure-related serious adverse events within 7 days of the procedure. Primary Effectiveness Endpoints Endpoint: Volume of fat aspirated per minute Definition: The lipoaspirate will be collected in the standard Lipografter bags and allowed to sediment for 15 minutes and the supernatant fat collected and its volume measured. The volume of fat collected during 12 minutes of liposuction will be calculated. Endpoint: ADSC count per ml of lipoaspirate (after enzymatic isolation \& culture) Definition: Stem cell colony count per ml of lipoaspirate after collagenase and trypsin enzymatic digestion Endpoint: Contour analysis of the liposuction sites, 1 month post-op Definition: Sum of the Likert scale (1-5) visual contour irregularity graded by the patient and the surgeon. 7.1 SELECTION CRITERIA The criteria listed below shall be used to determine if a participant is eligible for entry into the study. A subject must meet ALL of the study inclusion criteria and NONE of the study exclusion criteria in order to be considered eligible for participation. A. Inclusion Criteria Subjects are required to meet the following inclusion criteria: 1. Male or female 18 - 80 years of age. 2. Willingness, ability and commitment to participate in baseline and follow-up evaluations. 3. Signed patient informed consent form. B. Exclusion Criteria Subjects must NOT meet any of the following exclusion criteria: 1. Acute illness or active systemic infection or sepsis. 2. History of Hepatitis C or HIV/AIDS. 3. Women who are pregnant or breast feeding