Study to See How Low Level Laser Light Affects Subcutaneous Fat Around the Hips and Waist

NCT01292564 | Withdrawn

• 1 other identifier: EC-MRI001
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this pilot study is to demonstrate the anatomical modulation of subcutaneous fat across the waist and hips that occurs through application of the Erchonia® ML Scanner (MLS) Laser manufactured for non-invasive body contouring of the waist and hips.

Conditions

Weight Loss

Outcome Measures

Primary Outcomes (1)

• Fat Surface area (cm2) & projected fat volume (cm3) determined through MRI analysis

  2 weeks

Secondary Outcomes (3)

• Body Mass Index (BMI)

  2 weeks

• Hip circumference measurement in cm

  2 weeks

• Waist circumference measurement

  2 weeks

Study Arms (2)

Erchonia MLS

ACTIVE COMPARATOR

The Erchonia MLS emits 635 nm low level laser light.

Device: Erchonia MLS

Placebo Laser

PLACEBO COMPARATOR

The Placebo Laser looks identical to the Erchonia MLS Laser but emits no therapeutic light.

Device: Placebo Laser

Interventions

Erchonia MLS DEVICE

The Erchonia MLS emits 635 nm low level laser light.

Erchonia MLS

Placebo Laser DEVICE

The Placebo Laser looks identical to the Erchonia MLS Laser but emits no therapeutic light.

Placebo Laser

Eligibility Criteria

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

You may qualify if:

• Subject indicated for liposuction or use of liposuction techniques for the removal of localized deposits of adipose tissues; specifically for the indication of body contouring in the areas of the waist and hips. (As per the American Academy of Cosmetic Surgery's 2006 Guidelines for Liposuction Surgery).
• Body Mass Index (BMI) of 28 to 43 kg/m², inclusive.
• It is deemed safe for the subject to undergo a MRI procedure based on the MRI screening questionnaire.
• 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 diet and exercise regimen without effecting significant change in either direction during study participation.

You may not qualify if:

• Body Mass Index (BMI) is less than 28 kg/m² or greater than 43 kg/m².
• Diabetes dependent on insulin or oral hypoglycemic medications.
• Known cardiovascular disease.
• Prior cardiac surgery.
• 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/bloating/swelling and for which abstinence during study participation is not safe or medically prudent.
• Any medical condition known to affect weight levels/cause bloating/swelling.
• Diagnosis of, and/or taking medication for, irritable bowel syndrome.
• Active infection, wound or other external trauma to the laser treatment area.
• Pregnant, breast feeding, or planning pregnancy prior to study end.
• Serious mental health illness such as dementia or schizophrenia; 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 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 30 days.

Sponsors & Collaborators

• Erchonia Corporation: lead

Study Sites (1)

American Laser Centers

Fox River Grove, Illinois, 60021, United States

Location

MeSH Terms

Conditions

Weight Loss

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• David Turok, MD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2011
• First Posted: February 9, 2011
• Study Start: February 1, 2011
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: May 9, 2014

Record last verified: 2014-05

Locations

US (1)