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Trial record 35 of 2651 for:    ( Map: Idaho, United States )

Study of Low Level Laser Light Therapy on Circumference Reduction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02109107
Recruitment Status : Completed
First Posted : April 9, 2014
Results First Posted : February 2, 2016
Last Update Posted : February 2, 2016
Sponsor:
Information provided by (Responsible Party):
Erchonia Corporation

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Circumference Reduction
Intervention Device: Erchonia EZ6 Laser
Enrollment 54
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Erchonia® Zerona 6 Headed Scanner (EZ6) Laser
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The Erchonia® Zerona 6 Headed Scanner (EZ6) Laser is a 6 headed scanner composed of 6 independent 17 milliWatts (mW), 635 nanometer (nm) red laser diodes mounted in scanner devices. It is a variable frequency, pulsed wave laser device.

Erchonia EZ6 Laser: The Erchonia EZ6 is administered 6 times across 6 consecutive weeks, each administration seven days apart, each treatment lasting 60 minutes.

Period Title: Overall Study
Started 54
Completed 52
Not Completed 2
Reason Not Completed
Lost to Follow-up             2
Arm/Group Title Erchonia EZ6 Laser
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The Erchonia EZ6 Laser is a 6 headed scanner composed of 6 independent 17 milliWatts (mW), 635 nanometer (nm) red laser diodes mounted in scanner devices. It is a variable frequency, pulsed wave laser device.

Erchonia EZ6 Laser: The Erchonia EZ6 is administered 6 times across 6 consecutive weeks, each administration seven days apart, each treatment lasting 60 minutes.

Overall Number of Baseline Participants 54
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 54 participants
46.39  (9.83)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 54 participants
Female
51
  94.4%
Male
3
   5.6%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 54 participants
American Indian or Alaska Native
0
   0.0%
Asian
1
   1.9%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
4
   7.4%
White
49
  90.7%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 54 participants
54
1.Primary Outcome
Title Change in Combined Circumference Measurements
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Combined circumference measurement is calculated as the sum of the measurements for the individual body areas of the right and left thighs, hips, waist and upper abdomen. Change in combined circumference measurements is calculated as the difference in measurements from baseline to after completion of the 6-week procedure administration period. A negative (-) change indicates a reduction in combined circumference measurement across the evaluation period and is positive for study success. A positive (+) change indicates an increase in combined circumference measurements across the evaluation period and is negative for study success.

A mean change for the study subject group of -3.0 inches or more in combined circumference measurements will be considered a clinically meaningful and statistically significant positive change indicative of study success.

Time Frame Baseline and 6 weeks
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Erchonia EZ6 Laser
Hide Arm/Group Description:

The Erchonia EZ6 Laser is a 6 headed scanner composed of 6 independent 17 milliWatts (mW), 635 nanometer (nm) red laser diodes mounted in scanner devices. It is a variable frequency, pulsed wave laser device.

Erchonia EZ6 Laser: The Erchonia EZ6 is administered 6 times across 6 consecutive weeks, each administration seven days apart, each treatment lasting 60 minutes.

Overall Number of Participants Analyzed 54
Mean (Standard Deviation)
Unit of Measure: inches
-5.36  (1.85)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Erchonia EZ6 Laser
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments [Not Specified]
Method t-test, 2 sided
Comments t=21.33; df=53
2.Secondary Outcome
Title Change in Body Weight
Hide Description Body weight was measured in pounds at each evaluation point. The change in body weight measured in pounds at 6 weeks post-procedure administration relative to baseline was calculated. An increase in body weight indicated that weight was gained across the study evaluation period while a decrease in body weight indicated that weight was lost across the study evaluation period.
Time Frame Baseline and 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Erchonia EZ6 Laser
Hide Arm/Group Description:

The Erchonia EZ6 Laser is a 6 headed scanner composed of 6 independent 17 milliWatts (mW), 635 nanometer (nm) red laser diodes mounted in scanner devices. It is a variable frequency, pulsed wave laser device.

Erchonia EZ6 Laser: The Erchonia EZ6 is administered 6 times across 6 consecutive weeks, each administration seven days apart, each treatment lasting 60 minutes.

Overall Number of Participants Analyzed 54
Mean (Standard Deviation)
Unit of Measure: pounds
-1.40  (0.85)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Erchonia EZ6 Laser
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method t-test, 2 sided
Comments t=2.95; df=53
3.Secondary Outcome
Title Change in Body Mass Index (BMI)
Hide Description Body mass index (BMI) was measured in kilograms per meter squared (kg/m2) at each evaluation point. The change in BMI measured at 6 weeks post-procedure administration relative to baseline was calculated. An increase in BMI indicated that BMI increased across the study evaluation period which is negative for study success, while a decrease in BMI indicated that BMI decreased across the study evaluation period which is positive for study success.
Time Frame Baseline and 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Erchonia EZ6 Laser
Hide Arm/Group Description:

The Erchonia EZ6 Laser is a 6 headed scanner composed of 6 independent 17 milliWatts (mW), 635 nanometer (nm) red laser diodes mounted in scanner devices. It is a variable frequency, pulsed wave laser device.

Erchonia EZ6 Laser: The Erchonia EZ6 is administered 6 times across 6 consecutive weeks, each administration seven days apart, each treatment lasting 60 minutes.

Overall Number of Participants Analyzed 54
Mean (Standard Deviation)
Unit of Measure: kg/m2
-0.28  (0.11)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Erchonia EZ6 Laser
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.005
Comments [Not Specified]
Method t-test, 2 sided
Comments t+3.34; df=53
4.Secondary Outcome
Title Subject Satisfaction With Study Outcome Rating
Hide Description At the end of the study procedure administration phase, the subject was asked to indicate how satisfied or dissatisfied they were with any change noticed in the appearance of the thighs, hips, waist and upper abdomen area after having received the procedures with the EZ6?”, using the following five-point scale: Very Satisfied; Somewhat Satisfied; Neither Satisfied nor Dissatisfied; Not Very Satisfied; Not at All Satisfied
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Erchonia EZ6 Laser
Hide Arm/Group Description:

The Erchonia EZ6 Laser is a 6 headed scanner composed of 6 independent 17 milliWatts (mW), 635 nanometer (nm) red laser diodes mounted in scanner devices. It is a variable frequency, pulsed wave laser device.

Erchonia EZ6 Laser: The Erchonia EZ6 is administered 6 times across 6 consecutive weeks, each administration seven days apart, each treatment lasting 60 minutes.

Overall Number of Participants Analyzed 52
Measure Type: Number
Unit of Measure: participants
Very Satisfied 28
Somewhat Satisfied 14
Neither Satisfied Nor Dissatisfied 4
Not Very Satisfied 3
Not At All Satisfied 3
Time Frame 8 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Erchonia EZ6 Laser
Hide Arm/Group Description

The Erchonia EZ6 Laser is a 6 headed scanner composed of 6 independent 17 milliWatts (mW), 635 nanometer (nm) red laser diodes mounted in scanner devices. It is a variable frequency, pulsed wave laser device.

Erchonia EZ6 Laser: The Erchonia EZ6 is administered 6 times across 6 consecutive weeks, each administration seven days apart, each treatment lasting 60 minutes.

All-Cause Mortality
Erchonia EZ6 Laser
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Erchonia EZ6 Laser
Affected / at Risk (%)
Total   0/54 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Erchonia EZ6 Laser
Affected / at Risk (%)
Total   0/54 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Elvira Walls, Clinical Consultant
Organization: Regulatory Insight, Inc.
Phone: 615-712-9743
EMail: elvira@reginsight.com
Layout table for additonal information
Responsible Party: Erchonia Corporation
ClinicalTrials.gov Identifier: NCT02109107     History of Changes
Other Study ID Numbers: EC_EZ6_BC_001
First Submitted: April 7, 2014
First Posted: April 9, 2014
Results First Submitted: December 31, 2015
Results First Posted: February 2, 2016
Last Update Posted: February 2, 2016