NCT00738426

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2007

Shorter than P25 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 18, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 20, 2008

Completed
5.7 years until next milestone

Results Posted

Study results publicly available

May 2, 2014

Completed
Last Updated

February 10, 2020

Status Verified

January 1, 2020

Enrollment Period

8 months

First QC Date

August 18, 2008

Results QC Date

February 25, 2014

Last Update Submit

January 26, 2020

Conditions

Body Contouring

Keywords

non-invasive body contouring of waists hips and thighs

Outcome Measures

Primary Outcomes (1)

  • Incidence of the Reduction of at Least 3.0 Inches Off Their Combined Waist-hips-thighs Circumference.

    2 weeks

Study Arms (2)

Erchonia ML Scanner (MLS)

ACTIVE COMPARATOR

Red diode low level laser light energy

Device: Erchonia ML Scanner (MLS)

Sham device

SHAM COMPARATOR

non-therapeutic sham light output

Device: Sham device

Interventions

Erchonia ML Scanner (MLS)DEVICE

Red diode low level laser light energy.

Erchonia ML Scanner (MLS)
Sham deviceDEVICE

non-therapeutic light energy output

Sham device

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • to 65 years.
  • Male or female.

You may not qualify if:

  • 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.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Douglas D. Dedo, MD, FACS

Palm Beach Gardens, Florida, 33410, United States

Location

Cosmetic Surgery

Marion, Indiana, 46952, United States

Location

Dr. Gregory C. Roche

Bloomfield Hills, Michigan, 48302, United States

Location

Results Point of Contact

Title
Dr. Robert F. Jackson
Organization
Cosmetic Surgery
rjlipodr@comteck.com
765-662-8303

Study Officials

  • Gregory C Roche, MD, FACS

    PRINCIPAL INVESTIGATOR

  • Robert F Jackson, MD, FACS

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

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

August 18, 2008

First Posted

August 20, 2008

Study Start

October 1, 2007

Primary Completion

June 1, 2008

Study Completion

July 1, 2008

Last Updated

February 10, 2020

Results First Posted

May 2, 2014

Record last verified: 2020-01

Locations

US(3)