Clinical trial NCT02591056: Study of the Combined Effect of Low Level Laser Therapy and Manual Lymph Drainage on Reducing Body Circumference
Official title: An Evaluation of the Combined Effect of the Erchonia® Verju™ Laser With the Green PRESS 8 Lymph Drainage System on the Reduction of Body Circumference
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Circumference Reduction
Lead sponsor: Erchonia Corporation
Sponsor class: INDUSTRY
First posted: 2015-10-29
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Body Mass Index (BMI) between 25 kg/m² and 40 kg/m², inclusive.
* Subject indicated for liposuction or use of liposuction techniques for the removal of localized deposits of adipose tissues that do not respond to diet and exercise; specifically for the indication of body contouring in the areas of the hips, waist and upper abdomen. (As per the American Academy of Cosmetic Surgery's 2006 Guidelines for Liposuction Surgery developed by A joint Ad Hoc Committee of the American Society of Lipo-Suction Surgery (ASLSS) and the American Academy of Cosmetic Surgery (AACS))
* Subject is willing and able to abstain from partaking in any treatment other than the study procedures (existing or new) to promote body contouring/circumference reduction/weight loss during the course of study participation.
* Subject is willing and able to maintain his or her regular (typical pre-study) diet and exercise regimen without effecting significant change in either direction during study participation.

Exclusion Criteria:

* Known cardiovascular disease such as cardiac arrhythmias, congestive heart failure.
* Cardiac surgeries such as cardiac bypass, heart transplant surgery, pacemakers.
* Prior surgical intervention for body sculpting/weight loss, such as liposuction, abdominoplasty, stomach stapling, lap band surgery, etc.
* Medical, physical, or other contraindications for body sculpting/weight loss.
* Current use of medication(s) known to affect weight levels/cause bloating or swelling and for which abstinence during the course of study participation is not safe or medically prudent.
* Any medical condition known to affect weight levels and/or to cause bloating or swelling.
* Diagnosis of, and/or taking medication for, irritable bowel syndrome.
* Active infection, open wound (e.g. sores, cuts, ulcers, burns, etc.) or other external trauma to the areas to be treated with the laser/lymphatic drainage system devices.
* Known photosensitivity disorder.
* Current active cancer or currently receiving treatment for cancer.
* History of blood clots or phlebitis, other bleeding disorder
* Pregnant, possibly pregnant or planning pregnancy prior to the end of study participation.
* Serious mental health illness such as dementia or schizophrenia; psychiatric hospitalization in past two years.
* Developmental disability or cognitive impairment that in the opinion of the investigator would preclude adequate comprehension of the informed consent form and/or ability to record the necessary study measurements.
* Involvement in litigation and/or a worker's compensation claim and/or receiving disability benefits related to weight-related and/or body shape issues.
* Participation in a clinical study or other type of research in the past 30 days.

Primary outcomes:
measure: Change in Combined Circumference Measurements
timeFrame: Baseline and 6 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Stockton
country: United States
facility: Stockton Plastic Surgery
state: California
city: Marion
country: United States
facility: Cosmetic Surgery
state: Indiana
city: Bloomfield Hills
country: United States
facility: Bloomfield Laser and Cosmetic Surgery Center
state: Michigan
Study officials:
name: Gregory C Roche, DO
role: PRINCIPAL_INVESTIGATOR
References: