The history of ZeronaZerona, sometimes called "non-surgical lipo -suction" is a low-level laser device developed by the Erchonia Corp. for non-invasive body slimming of the waist, hips, and thighs. The device was first introduced to the market in 2008 as an off-label use device for slimming, but later was granted 510k market clearance by the FDA (Food and Drug Administration) in 2010 indicated for use as a non-invasive dermatological aesthetic treatment for the reduction of circumference of hips, waist, and thighs. Zerona HistoryInitial trials for the Zerona began in late 1998 in Cali, Colombia, by Dr. Rodrigo Neira and his wife Dr. Clara Neira at the Universidad Nacional de Colombia. They first applied the device as an adjunct to liposuction to reduce pain and inflammation commonly experienced after the invasive surgical procedure. In hopes of achieving better pain reduction they began applying LLLT prior to aspiration and surprisingly found that the subcutaneous fat appeared softer and easier to extract. Fascinated with this finding, Dr. Neira and his wife started performing histological investigations to determine why laser had this unique biological influence on fat tissue. Utilizing scanning electron microscopy and transmission electron microscopy, they observed the formation of transitory pores or openings in the protective membranes of adipocytes, which enabled stored intracellular lipids to be released from enlarged fat cells. These findings prompted the development of a device, the EML Laser, to assist in the surgical procedure – liposuction--with the intent to emulsify the fat thereby softening the area prior to aspiration. The next logical transition was to evaluate the body's capacity to remove the liberated fatty material, in turn, positioning this technology as a non-invasive body slimming application.Clinical trial of ZeronaIn 2008, the clinical trial to investigate the efficacy of Zerona began. The trial enrolled 67 subjects, 35 of which were randomly assigned to receive "active" or "real" treatment with 32 randomly assigned to the "sham" or inactive group. Both groups were asked to sign an affidavit stating that during the clinical trial they would make no changes to their lifestyle and would not participate in any other program or consume any supplements that would promote slimming. Furthermore, patients were asked to track their daily activities and caloric intake through the entire duration of the trial. This daily journal ensured that patients were not making any changes that could impact the outcome. Patients received treatment every-other day for two weeks receiving a total of 6 treatments. Patients' waist, hips, and thighs were treated concurrently for 40 total minutes each treatment, including 20 minutes of anterior or front treatment and 20 minutes of posterior or back treatment. Measurements were taken at baseline, weeks one and two, and a two-week post-procedure follow-up measurement. After two weeks the "active" treatment group averaged a cumulative reduction of 3.54 inches compared to the "sham" group, which averaged a cumulative reduction of just 0.68 inches. At the two-week post-procedure follow-up, "active" group participants did not exhibit a significant gain in their measurements. If the circumference reduction in the study is re-calculated to a radius measure (i.e. a more just measure of fat layer thickness) the actual fat layers on waist, hips and thighs were reduced on average 2.8% or 0.05 inches (0.13 cm) for the "active" group two weeks after the last treatment. This should be compared to cryolipolysis, which on average results in a 25.5% reduction of fat layer thickness. No adverse events or side effects were reported during the clinical trial.The clinical trial for Zerona was published in the peer-reviewed journal Laser's in Surgery and Medicine in 2009. Today the Zerona laser is being utilized with patients by approximately 1,000 certified practitioners in North America. To date, Zerona has been used as a slimming treatment for over 80,000 patients in the US alone.
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