Study of the Combined Effect of Low Level Laser Therapy and Manual Lymph Drainage on Reducing Body Circumference

NCT02591056 | Terminated Results

• 1 other identifier: EC_VERJU+GP8_001
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 3

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.

Conditions

Circumference Reduction

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and 6 Weeks

Study Arms (1)

Erchonia Verju Laser + Green PRESS 8

EXPERIMENTAL

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

Interventions

Erchonia® Verju™ Laser DEVICE

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.

Erchonia Verju Laser + Green PRESS 8

Green PRESS 8 DEVICE

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.

Erchonia Verju Laser + Green PRESS 8

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Erchonia Corporation: lead

Study Sites (3)

Stockton Plastic Surgery

Stockton, California, 95219, United States

Location

Cosmetic Surgery

Marion, Indiana, 46952, United States

Location

Bloomfield Laser and Cosmetic Surgery Center

Bloomfield Hills, Michigan, 48302, United States

Location

Results Point of Contact

• Title: Elvira Cawthon, Clinical Consultant
• Organization: Regulatory Insight, Inc.

elvira@reginsight.com

615-712-9743

Study Officials

• Gregory C Roche, DO

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2015
• First Posted: October 29, 2015
• Study Start: January 1, 2016
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: February 10, 2020
• Results First Posted: September 8, 2016

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)