Study of Low Level Laser Therapy for Body Contouring

NCT ID: NCT00738426

Last Updated: 2020-02-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-10-31
• Study Completion Date: 2008-07-31

Brief Summary

The purpose of this study is to determine whether green diode low level laser therapy is effective for body contouring of the waist, hips and thighs.

Detailed Description

Weight loss and body contouring are large, constantly-growing fields of cosmetic surgery. According to the American Society of Plastic Surgeons (ASPS) statistics, more than 324,000 liposuction procedures, 233,000 eyelid surgeries and 114,000 facelift procedures were performed in 2004 in the United States alone. However, while the demand for body shaping procedures is constantly on the rise, so is the demand for such procedures to be performed more quickly, simply and most importantly, less invasively. Cosmetic surgery patients are no longer satisfied with procedures that require general anesthesia, pose a multitude of potentially serious risks and complications and that require several weeks of recovery time. Hence the growing popularity of non- to minimally-invasive cosmetic surgery procedures. In 2005, more than 7.5 million minimally-invasive cosmetic procedures were performed, a 35% increase from 2000. Consequently, patients and physicians alike are continually searching for non-invasive alternatives to traditional cosmetic procedures such as liposuction that are efficient, safe and effective.

Conditions

Body Contouring

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Erchonia ML Scanner (MLS)

Red diode low level laser light energy

Group Type: ACTIVE_COMPARATOR

Erchonia ML Scanner (MLS)

Intervention Type: DEVICE

Red diode low level laser light energy.

Sham device

non-therapeutic sham light output

Group Type: SHAM_COMPARATOR

Sham device

Intervention Type: DEVICE

non-therapeutic light energy output

Interventions

Erchonia ML Scanner (MLS)

Red diode low level laser light energy.

Intervention Type: DEVICE

Sham device

non-therapeutic light energy output

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• indicated for liposuction for the removal of localized deposits of adipose tissues that do not respond to diet and exercise; specifically in the areas of the waist, hips and bilateral thighs.
• willing and able to abstain from partaking in any treatment other than the study procedure (existing or new) to promote body contouring and/or weight loss during the course of study participation.
• willing and able to maintain regular diet and exercise regimen without during study participation.
• 18 to 65 years.
• Male or female.

Exclusion Criteria

• Body Mass Index (BMI) of 30 kg/m² or greater.
• Diabetes dependent on insulin or oral hypoglycemic medications.
• known cardiovascular disease.
• cardiac surgeries, pacemakers.
• excessive alcohol consumption.
• prior surgical intervention for body sculpting/weight loss.
• medical, physical, or other contraindications for body sculpting/weight loss.
• current use of medication(s) known to affect weight levels and/or to cause bloating or swelling and for which abstinence during the course of study participation is not safe or medically prudent.
• 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, wound or other external trauma to the areas to be treated with the laser.
• pregnant, breast feeding, or planning pregnancy prior to study end.
• serious mental health illness; psychiatric hospitalization in past two years.
• developmental disability or cognitive impairment that 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 research in the past 90 days.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Erchonia Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gregory C Roche, MD, FACS

Role: PRINCIPAL_INVESTIGATOR

Robert F Jackson, MD, FACS

Role: PRINCIPAL_INVESTIGATOR

Locations

Douglas D. Dedo, MD, FACS

Palm Beach Gardens, Florida, United States

Cosmetic Surgery

Marion, Indiana, United States

Dr. Gregory C. Roche

Bloomfield Hills, Michigan, United States

Countries

United States

Other Identifiers

BCL-001

Identifier Type: -

Identifier Source: org_study_id