Circumference ReductionNCT02591056
Study of the Combined Effect of Low Level Laser Therapy and Manual Lymph Drainage on Reducing Body Circumference
A study testing Erchonia® Verju™ Laser and Green PRESS 8 in people with Circumference Reduction, run by Erchonia Corporation at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Circumference Reduction
- What is being tested?
- Erchonia® Verju™ Laser and Green PRESS 8
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 3 sitesUnited States
- Study dates
- Jan 2016to Jun 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 16Show fewer
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Bloomfield Laser and Cosmetic Surgery Center
Bloomfield Hills, Michigan, 48302
Cosmetic Surgery
Marion, Indiana, 46952
Stockton Plastic Surgery
Stockton, California, 95219
About this study
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
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.
Read the 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.
- Conditions
- Circumference Reduction
- Being tested
- Erchonia® Verju™ Laser, Green PRESS 8
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erchonia® Verju™ LaserDevice
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.
Green PRESS 8Device
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Erchonia® Verju™ Laser; Device: Green PRESS 8 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 6 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2015 (estimated)
- Study startJan 2016
- Primary completionJun 2016
- Study completionJun 2016
Why it stopped: Sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Circumference ReductionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erchonia Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gregory C Roche, DO, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02591056
- Sponsor's protocol ID
- EC_VERJU+GP8_001
- Status last verified
- Jan 2020
- First submitted
- 28 Oct 2015
- Last updated
- 10 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02591056
- Acronym / sponsor ID
- EC_VERJU+GP8_001
- Conditions
- Circumference Reduction
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Erchonia CorporationIndustry (pharma, biotech, devices)
- Study start
- Jan 2016
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 29 Oct 2015 (estimated)
- Results
- Posted 8 Sep 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Erchonia Verju Laser + Green PRESS 8 | Experimental | Device: Erchonia® Verju™ Laser, Device: Green PRESS 8All subjects receive 12 combination treatments over 6 weeks (two per week) with the Erchonia® Verju™ Laser and the Green PRESS 8 devices simultaneously. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Erchonia® Verju™ LaserThere 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. | Device | Erchonia Verju Laser + Green PRESS 8 |
| Green PRESS 8There 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. | Device | Erchonia Verju Laser + Green PRESS 8 |
Primary outcome
Change in Combined Circumference Measurements
Time frame: Baseline and 6 Weeks
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gregory C Roche, DO principal investigator
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Erchonia® Verju™ Laser and Green PRESS 8 in people with Circumference Reduction, run by Erchonia Corporation at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Sep 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Combined Circumference Measurements (time frame: Baseline and 6 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2020.