CompletedNot Applicable

Efficacy Study of the Effect of Low Level Laser Light Therapy on Reducing Upper Arm Circumference

62 participantsStarted 2011-03

Plain-language summary

The purpose of this study is to determine if the Erchonia® ML Scanner (MLS) low level light laser device can help to reduce the circumference of the upper arms.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 of the bilateral upper arms (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 Liposuction Surgery (ASLSS) and the American Academy of Cosmetic Surgery (AACS)), and/or for the procedure of brachioplasty (upper arm lift). * Body Mass Index (BMI) of 20 to 35 kg/m². * Subject is willing and able to abstain from partaking in any treatment other than the study procedure to promote body contouring and/or weight loss during study participation. * Subject is willing and able to maintain his or her regular (typical pre-study procedure) diet and exercise regimen without effecting significant change in either direction during study participation. Exclusion Criteria: * Subject is seeking upper arm body contouring as a means of weight loss. * Diabetes dependent on insulin or oral hypoglycemic medications. * 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 of the arms, such as liposuction or brachioplasty. * Prior surgical intervention for weight loss, such as stomach stapling, lap ba…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Combined Upper Arm Circumference Measurements From Baseline to Endpoint

Timeframe: baseline and 2 weeks

Trial details

NCT IDNCT01376037

SponsorErchonia Corporation

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2012-01

Results submitted2013-04-11

View on ClinicalTrials.gov More Body Contouring trials

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.