NCT01292538

Brief Summary

The purpose of this study is to determine if 532nm green diode laser light is effective in 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
67

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2011

Geographic Reach
1 country

2 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

February 1, 2011

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

February 8, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 9, 2011

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
2 years until next milestone

Results Posted

Study results publicly available

June 3, 2014

Completed
Last Updated

February 10, 2020

Status Verified

January 1, 2020

Enrollment Period

1.3 years

First QC Date

February 8, 2011

Results QC Date

April 1, 2014

Last Update Submit

January 26, 2020

Conditions

Body Contouring

Outcome Measures

Primary Outcomes (1)

  • Combined Circumference in Inches of the Waist, Hips and Bilateral Thighs

    Mean change in total combined circumference inches of the waist, hips and bilateral thighs from baseline to endpoint evaluation.

    2 weeks

Study Arms (2)

Erchonia GLS 532nm

EXPERIMENTAL

532nm green laser light therapy.

Device: Erchonia GLS

Placebo laser

SHAM COMPARATOR

Sham light output with no therapeutic benefit

Device: Placebo laser

Interventions

Erchonia GLSDEVICE

532 nm green diode low level laser light device

Erchonia GLS 532nm
Placebo laserDEVICE

Sham light output with no therapeutic benefit

Placebo laser

Eligibility Criteria

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

You may qualify if:

  • Body Mass Index (BMI) less than 30 kg/m²
  • 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 waist, hips and bilateral thighs. (As per the American Academy of Cosmetic Surgery's 2006 Guidelines for Liposuction Surgery).
  • 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) of 30 kg/m² or greater.
  • Diabetic dependent on insulin or oral hypoglycemic medications.
  • Known cardiovascular disease.
  • Prior cardiac surgery.
  • Prior surgical intervention for body sculpting/weight loss, such as liposuction, abdominoplasty, stomach stapling, lap band surgery.
  • Medical, physical, or other contraindications for body sculpting/weight loss.
  • Use of medication(s) known to affect weight levels and/or to cause bloating or swelling and for which abstinence during study participation is not safe or medically prudent.
  • Any medical condition known to affect weight levels and/or 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.
  • Photosensitivity disorder.
  • Current cancer or receiving treatment for cancer.
  • 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.
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Surgeon's Inc.

Marion, Indiana, 46952, United States

Location

Bloomfield Laser and Cosmetic Surgery Center

Bloomfield Hills, Michigan, 48302, United States

Location

Results Point of Contact

Title
Elvira Walls
Organization
Regulatory Insight, Inc.
elvira@reginsight.com
615-712-9743

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

February 8, 2011

First Posted

February 9, 2011

Study Start

February 1, 2011

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

February 10, 2020

Results First Posted

June 3, 2014

Record last verified: 2020-01

Locations

US(2)