Trial Outcomes & Findings for Study of the Combined Effect of Low Level Laser Therapy and Manual Lymph Drainage on Reducing Body Circumference (NCT NCT02591056)
NCT ID: NCT02591056
Last Updated: 2020-02-10
Results Overview
Combined circumference measurement is calculated as the sum of the measurements for the individual body areas of the 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.
TERMINATED
NA
27 participants
Baseline and 6 Weeks
2020-02-10
Participant Flow
Participant milestones
| Measure |
Erchonia Verju Laser + Green PRESS 8
All subjects receive 12 combination treatments over 6 weeks (two per week) with the Erchonia® Verju™ Laser and the Green PRESS 8 devices simultaneously.
Erchonia Verju Laser + Green PRESS 8: There are 12 combined procedure administrations with the Erchonia® Verju™ Laser and the Green PRESS 8 simultaneously across 6 weeks: 2 procedures per week. For each procedure administration, the Erchonia Verju is applied to the midsection for 30 minutes: 15 minutes front and 15 minutes back, followed by administration of the Green PRESS 8 to the midsection for 30 minutes. All subjects receive the combination Erchonia Verju Laser + Green PRESS 8 treatment for all 12 procedure administrations.
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|---|---|
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Overall Study
STARTED
|
27
|
|
Overall Study
COMPLETED
|
27
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of the Combined Effect of Low Level Laser Therapy and Manual Lymph Drainage on Reducing Body Circumference
Baseline characteristics by cohort
| Measure |
Erchonia Verju Laser + Green PRESS 8
n=27 Participants
All subjects receive 12 combination treatments over 6 weeks (two per week) with the Erchonia® Verju™ Laser and the Green PRESS 8 devices simultaneously.
Erchonia Verju Laser + Green PRESS 8: There are 12 combined procedure administrations with the Erchonia® Verju™ Laser and the Green PRESS 8 simultaneously across 6 weeks: 2 procedures per week. For each procedure administration, the Erchonia Verju is applied to the midsection for 30 minutes: 15 minutes front and 15 minutes back, followed by administration of the Green PRESS 8 to the midsection for 30 minutes. All subjects receive the combination Erchonia Verju Laser + Green PRESS 8 treatment for all 12 procedure administrations.
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|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
26 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=99 Participants
|
|
Age, Continuous
|
44.15 years
STANDARD_DEVIATION 13.13 • n=99 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
26 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
27 participants
n=99 Participants
|
|
Combined Circumference
|
112.34 inches
STANDARD_DEVIATION 13.67 • n=99 Participants
|
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Body Mass Index (BMI)
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30.64 kg/m^2
STANDARD_DEVIATION 3.97 • n=99 Participants
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PRIMARY outcome
Timeframe: Baseline and 6 WeeksCombined circumference measurement is calculated as the sum of the measurements for the individual body areas of the 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.
Outcome measures
| Measure |
Erchonia Verju Laser + Green PRESS 8
n=27 Participants
All subjects receive 12 combination treatments over 6 weeks (two per week) with the Erchonia® Verju™ Laser and the Green PRESS 8 devices simultaneously.
Erchonia Verju Laser + Green PRESS 8: There are 12 combined procedure administrations with the Erchonia® Verju™ Laser and the Green PRESS 8 simultaneously across 6 weeks: 2 procedures per week. For each procedure administration, the Erchonia Verju is applied to the midsection for 30 minutes: 15 minutes front and 15 minutes back, followed by administration of the Green PRESS 8 to the midsection for 30 minutes. All subjects receive the combination Erchonia Verju Laser + Green PRESS 8 treatment for all 12 procedure administrations.
|
|---|---|
|
Change in Combined Circumference Measurements
|
-3.88 inches
Standard Deviation 2.70
|
Adverse Events
Erchonia Verju Laser + Green PRESS 8
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Elvira Cawthon, Clinical Consultant
Regulatory Insight, Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place