An interventional study of Erchonia® Verju™ Laser and Green PRESS 8 in Circumference Reduction, sponsored by Erchonia Corporation. Terminated at 3 sites in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-02-10.
Sponsored by Erchonia Corporation · Not applicable, Interventional, and Treatment
The purpose of this study is to determine whether low level laser light therapy applied using the Erchonia Verju Laser combined with manual lymph drainage applied using the Iskra Medical Green PRESS 8 Lymph Drainage System is effective in reducing the circumference of the waist, hips and upper abdomen.
The American Society of Plastic Surgeons (ASPS) 2011 report states that the market for cosmetic procedures has shown significant growth over the past two years, with 13.8 million cosmetic plastic surgery procedures performed in the United States in 2011, up 5% since 2010. While surgical cosmetic procedures significantly increased from 2010 to 2011, the overall growth in cosmetic procedures is primarily driven by a substantial rise in minimally-invasive procedures that increased 6%, with nearly 12.2 million cosmetic minimally-invasive procedures having been performed in 2011. This highlights the growing consumer demand for non- or minimally-invasive cosmetic procedures that do not involve surgical procedures such as liposuction and the associated risks, potential complications and lengthy and painful recovery processes.
Low level laser light therapy (LLLT) offers a simple, non-invasive, safe, effective and side-effect free alternative to achieving body circumference reduction. Erchonia low level lasers, including the Erchonia® Verju™ Laser, have been determined safe and effective by the FDA for application for body circumference reduction indications for multiple body areas.
The Iskra Medical Green PRESS 8 is a manual lymph drainage system that is also a simple, non-invasive, safe and side-effect free alternative to achieving body circumference reduction that has demonstrated optimal effectiveness when used in combination with other established alternative non-invasive means of body circumference reduction such as LLLT application.
LLLT, as applied with the Erchonia® Verju™ Laser, effects a transitory pore in the adipocyte cell membrane that enables the fat to pass from the intracellular space into the extra-cellular space. The Green PRESS 8 operates according to the principle of manual lymph drainage, employing pumping of air under controlled pressure into inflatable cuffs according to pre-set pressure, compression pause duration and therapy time parameters. The alternating release and compression of the different vascular and lymphatic structures effects and enhances lymphatic drainage that results in an influx of blood along with nourishing elements, and the elimination of fluids and metabolic waste products. When used in combination with LLLT, this process enhances and accelerates the process of reduction in the size of adipocyte cells through increased liquefaction and emulsification of the fat through the transitory pore in the adipocyte cell, which has been initiated by the preceding application of LLLT.
The purpose of this study is to evaluate if green diode LLLT as applied with the Erchonia® Verju™ Laser is more effective on reducing the circumference of the hips, waist and upper abdomen when used in combination with the Green PRESS 8 manual lymph drainage system twice weekly for six weeks than when used alone.
Erchonia Corporation is the lead sponsor of 48 studies on the registry; 2 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 14 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
All subjects receive 12 combination treatments over 6 weeks (two per week) with the Erchonia® Verju™ Laser and the Green PRESS 8 devices simultaneously.
Device: Erchonia® Verju™ Laser · Device: Green PRESS 8
There are 12 procedure administrations with the Erchonia® Verju™ Laser across 6 weeks: 2 procedures per week. For each procedure administration, the Erchonia Verju is applied to the midsection for 30 minutes: 15 minutes to the front and 15 minutes to the back. All subjects receive the active Erchonia Verju Laser treatment for all 12 procedure administrations.
There are 12 procedure administrations with the Green PRESS 8 across 6 weeks: 2 procedures per week. For each procedure administration, the Green PRESS 8 is applied to the midsection for 30 minutes. All subjects receive the active Green PRESS 8 treatment for all 12 procedure administrations. Each Green PRESS 8 procedure administration occurs right after each procedure administration with the Erchonia Verju Laser.
Change in Combined Circumference Measurements
Combined circumference measurement is calculated as the sum of the measurements for the individual body areas of the hips, waist and upper abdomen. Change in combined circumference measurements is calculated as the difference in measurements from baseline to after completion of the 6-week procedure administration period. A negative (-) change indicates a reduction in combined circumference measurement across the evaluation period and is positive for study success. A positive (+) change indicates an increase in combined circumference measurements across the evaluation period and is negative for study success. A mean change for the study subject group of -3.0 inches or more in combined circumference measurements will be considered a clinically meaningful and statistically significant positive change indicative of study success.
Time frame: Baseline and 6 Weeks
| Milestone | Erchonia Verju Laser + Green PRESS 8 |
|---|---|
| Started | 27 |
| Completed | 27 |
| Not completed | 0 |
Combined circumference measurement is calculated as the sum of the measurements for the individual body areas of the hips, waist and upper abdomen. Change in combined circumference measurements is calculated as the difference in measurements from baseline to after completion of the 6-week procedure administration period. A negative (-) change indicates a reduction in combined circumference measurement across the evaluation period and is positive for study success. A positive (+) change indicates an increase in combined circumference measurements across the evaluation period and is negative for study success. A mean change for the study subject group of -3.0 inches or more in combined circumference measurements will be considered a clinically meaningful and statistically significant positive change indicative of study success.
| inches | Erchonia Verju Laser + Green PRESS 8 |
|---|---|
| Change in Combined Circumference Measurements | -3.88 ± 2.70 |
Collected over 8 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Erchonia Verju Laser + Green PRESS 8 | — | 0/27 (0%) | 0/27 (0%) |
| Age, Categorical(Participants) | Erchonia Verju Laser + Green PRESS 8 |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 26 |
| >=65 years | 1 |
| Age, Continuous(years) | Erchonia Verju Laser + Green PRESS 8 |
|---|---|
| Mean | 44.15 ± 13.13 |
| Sex: Female, Male(Participants) | Erchonia Verju Laser + Green PRESS 8 |
|---|---|
| Female | 22 |
| Male | 5 |
| Ethnicity (NIH/OMB)(Participants) | Erchonia Verju Laser + Green PRESS 8 |
|---|---|
| Hispanic or Latino | 1 |
| Not Hispanic or Latino | 26 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Erchonia Verju Laser + Green PRESS 8 |
|---|---|
| United States | 27 |
| Combined Circumference(inches) | Erchonia Verju Laser + Green PRESS 8 |
|---|---|
| Mean | 112.34 ± 13.67 |
| Body Mass Index (BMI)(kg/m^2) | Erchonia Verju Laser + Green PRESS 8 |
|---|---|
| Mean | 30.64 ± 3.97 |
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