Trial Outcomes & Findings for Comparing the Efficacy of a Dual-Frequency LLLT Device With a Sham Device as a Therapy for Adipose Tissue Loss (NCT NCT03811093)
NCT ID: NCT03811093
Last Updated: 2022-09-15
Results Overview
Measured change in body fat as a percentage of total weight.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
39 participants
Primary outcome timeframe
In order to determine change over time, body fat as a percentage of body weight will be measured before any treatment at first therapy session and measured again for comparison at the end of three weeks therapy.
Results posted on
2022-09-15
Participant Flow
The Trial recruitment period had a start date of January 14th and ended on January 19th 2019. (A total of 6 days) All participant recruitment and interviews were conducted at the Cross Chiropractic Center in Hixson, TN.
Participant milestones
| Measure |
Care as Usual Group
A randomly selected group of approximately 20 participants who will receive treatment per the prescribed trial protocol using a fully functional invisa-RED Technology Elite device. Treatment protocol is as follows: Participants will undergo nine (9) therapy sessions of 20 minutes each over a three week period; using a singular Low-level Laser Therapy (LLLT) protocol setting for pulse (3.5s) and delay (0.2s), however power settings will be based on the participants Fitzpatrick Scale skin type. For skin types i and ii a power setting of 7 will be used, for skin types iii and iv a power setting of 6, for skin types v and vi a power setting of 4 will be employed.
Care as Usual Group: Each participant randomly assigned to the "Care As Usual Group" will undergo nine therapy sessions over three weeks using a fully functioning invisa-RED Technology Elite device.
|
Sham Group
A randomly selected group of approximately 20 participants who will receive treatment per the prescribed trial protocol using a non functional invisa-RED Technology Elite device. (The sham device will be disabled and will deliver no Low-level Laser Light energy during therapy.) Treatment protocol is as follows: Participants will undergo nine (9) therapy sessions of 20 minutes each over a three week period; using a singular protocol setting for pulse (3.5s) and delay (0.2s), however power settings will be based on the participants Fitzpatrick Scale skin type. For skin types i and ii a power setting of 7 will be used, for skin types iii and iv a power setting of 6, for skin types v and vi a power setting of 4 will be employed.
Sham Group: Each participant randomly assigned to the "Sham Group" will undergo nine therapy sessions over three weeks using a non functioning invisa-RED Technology Elite device.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
19
|
|
Overall Study
COMPLETED
|
18
|
15
|
|
Overall Study
NOT COMPLETED
|
2
|
4
|
Reasons for withdrawal
| Measure |
Care as Usual Group
A randomly selected group of approximately 20 participants who will receive treatment per the prescribed trial protocol using a fully functional invisa-RED Technology Elite device. Treatment protocol is as follows: Participants will undergo nine (9) therapy sessions of 20 minutes each over a three week period; using a singular Low-level Laser Therapy (LLLT) protocol setting for pulse (3.5s) and delay (0.2s), however power settings will be based on the participants Fitzpatrick Scale skin type. For skin types i and ii a power setting of 7 will be used, for skin types iii and iv a power setting of 6, for skin types v and vi a power setting of 4 will be employed.
Care as Usual Group: Each participant randomly assigned to the "Care As Usual Group" will undergo nine therapy sessions over three weeks using a fully functioning invisa-RED Technology Elite device.
|
Sham Group
A randomly selected group of approximately 20 participants who will receive treatment per the prescribed trial protocol using a non functional invisa-RED Technology Elite device. (The sham device will be disabled and will deliver no Low-level Laser Light energy during therapy.) Treatment protocol is as follows: Participants will undergo nine (9) therapy sessions of 20 minutes each over a three week period; using a singular protocol setting for pulse (3.5s) and delay (0.2s), however power settings will be based on the participants Fitzpatrick Scale skin type. For skin types i and ii a power setting of 7 will be used, for skin types iii and iv a power setting of 6, for skin types v and vi a power setting of 4 will be employed.
Sham Group: Each participant randomly assigned to the "Sham Group" will undergo nine therapy sessions over three weeks using a non functioning invisa-RED Technology Elite device.
|
|---|---|---|
|
Overall Study
Lack of Efficacy, Withdrawal by Subject
|
0
|
4
|
|
Overall Study
Unable to measure body fat percentage
|
2
|
0
|
Baseline Characteristics
Number of Sham Group was reduced by a drop out of 4 participants due to schedule conflicts and lack of efficacy.
Baseline characteristics by cohort
| Measure |
Care as Usual Group
n=20 Participants
A randomly selected group of 20 participants who will receive treatment per the prescribed trial protocol using a fully functional invisa-RED Technology Elite device. Treatment protocol is as follows: Participants will undergo nine (9) therapy sessions of 20 minutes each over a three week period; using a singular LLLT protocol setting for pulse (3.5s) and delay (0.2s), however power settings will be based on the participants Fitzpatrick Scale skin type. For skin types i and ii a power setting of 7 will be used, for skin types iii and iv a power setting of 6, for skin types v and vi a power setting of 4 will be employed.
Care as Usual Group: Each participant randomly assigned to the "Care As Usual Group" will undergo nine therapy sessions over three weeks using a fully functioning invisa-RED Technology Elite device.
|
Sham Group
n=19 Participants
A randomly selected group of 20 participants who will receive treatment per the prescribed trial protocol using a non functional invisa-RED Technology Elite device. (The sham device will be disabled and will deliver no low laser light energy during therapy.) Treatment protocol is as follows: Participants will undergo nine (9) therapy sessions of 20 minutes each over a three week period; using a singular protocol setting for pulse (3.5s) and delay (0.2s), however power settings will be based on the participants Fitzpatrick Scale skin type. For skin types i and ii a power setting of 7 will be used, for skin types iii and iv a power setting of 6, for skin types v and vi a power setting of 4 will be employed.
Sham Group: Each participant randomly assigned to the "Sham Group" will undergo nine therapy sessions over three weeks using a non functioning invisa-RED Technology Elite device.
|
Total
n=39 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Body Circumference Measurements
|
225.19 Inches
STANDARD_DEVIATION 30.64 • n=20 Participants • Number of Sham Group was reduced by a drop out of 4 participants due to schedule conflicts and lack of efficacy.
|
222.58 Inches
STANDARD_DEVIATION 24.83 • n=15 Participants • Number of Sham Group was reduced by a drop out of 4 participants due to schedule conflicts and lack of efficacy.
|
224.07 Inches
STANDARD_DEVIATION 27.93 • n=35 Participants • Number of Sham Group was reduced by a drop out of 4 participants due to schedule conflicts and lack of efficacy.
|
|
Age, Continuous
|
48.6 years
STANDARD_DEVIATION 9.22 • n=20 Participants
|
50.6 years
STANDARD_DEVIATION 13.30 • n=19 Participants
|
49.46 years
STANDARD_DEVIATION 11.01 • n=39 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=20 Participants
|
16 Participants
n=19 Participants
|
35 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=20 Participants
|
3 Participants
n=19 Participants
|
4 Participants
n=39 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
20 participants
n=20 Participants
|
19 participants
n=19 Participants
|
39 participants
n=39 Participants
|
|
Percentage Body Fat
|
40.38 Percent Body Fat
STANDARD_DEVIATION 6.25 • n=18 Participants • 1. Number of "Care as Usual Group" participants measured was reduced by two morbidly obese participants whose body fat percentage could not be accurately measured. 2. Number of Sham Group was reduced by a drop out of 4 participants due to schedule conflicts and lack of efficacy.
|
39.63 Percent Body Fat
STANDARD_DEVIATION 6.90 • n=15 Participants • 1. Number of "Care as Usual Group" participants measured was reduced by two morbidly obese participants whose body fat percentage could not be accurately measured. 2. Number of Sham Group was reduced by a drop out of 4 participants due to schedule conflicts and lack of efficacy.
|
40.04 Percent Body Fat
STANDARD_DEVIATION 6.46 • n=33 Participants • 1. Number of "Care as Usual Group" participants measured was reduced by two morbidly obese participants whose body fat percentage could not be accurately measured. 2. Number of Sham Group was reduced by a drop out of 4 participants due to schedule conflicts and lack of efficacy.
|
|
Weight of Body Fat
|
82.80 Pounds
STANDARD_DEVIATION 28.12 • n=18 Participants • 1. Number of "Care as Usual Group" participants measured was reduced by two morbidly obese participants whose body fat percentage could not be accurately measured. 2. Number of Sham Group was reduced by a drop out of 4 participants due to schedule conflicts and lack of efficacy.
|
85.81 Pounds
STANDARD_DEVIATION 26.06 • n=15 Participants • 1. Number of "Care as Usual Group" participants measured was reduced by two morbidly obese participants whose body fat percentage could not be accurately measured. 2. Number of Sham Group was reduced by a drop out of 4 participants due to schedule conflicts and lack of efficacy.
|
84.17 Pounds
STANDARD_DEVIATION 26.83 • n=33 Participants • 1. Number of "Care as Usual Group" participants measured was reduced by two morbidly obese participants whose body fat percentage could not be accurately measured. 2. Number of Sham Group was reduced by a drop out of 4 participants due to schedule conflicts and lack of efficacy.
|
PRIMARY outcome
Timeframe: In order to determine change over time, body fat as a percentage of body weight will be measured before any treatment at first therapy session and measured again for comparison at the end of three weeks therapy.Population: 1. Number of "Care as Usual Group" participants measured was reduced by two morbidly obese participants whose body fat percentage could not be accurately measured. 2. Number of Sham Group was reduced by a drop out of 4 participants due to schedule conflicts and lack of efficacy.
Measured change in body fat as a percentage of total weight.
Outcome measures
| Measure |
Care as Usual Group
n=18 Participants
A randomly selected group of approximately 20 participants who will receive treatment per the prescribed trial protocol using a fully functional invisa-RED Technology Elite device. Treatment protocol is as follows: Participants will undergo nine (9) therapy sessions of 20 minutes each over a three week period; using a singular LLLT protocol setting for pulse (3.5s) and delay (0.2s), however power settings will be based on the participants Fitzpatrick Scale skin type. For skin types i and ii a power setting of 7 will be used, for skin types iii and iv a power setting of 6, for skin types v and vi a power setting of 4 will be employed.
Care as Usual Group: Each participant randomly assigned to the "Care As Usual Group" will undergo nine therapy sessions over three weeks using a fully functioning invisa-RED Technology Elite device.
|
Sham Group
n=15 Participants
A randomly selected group of approximately 20 participants who will receive treatment per the prescribed trial protocol using a non functional invisa-RED Technology Elite device. (The sham device will be disabled and will deliver no low laser light energy during therapy.) Treatment protocol is as follows: Participants will undergo nine (9) therapy sessions of 20 minutes each over a three week period; using a singular protocol setting for pulse (3.5s) and delay (0.2s), however power settings will be based on the participants Fitzpatrick Scale skin type. For skin types i and ii a power setting of 7 will be used, for skin types iii and iv a power setting of 6, for skin types v and vi a power setting of 4 will be employed.
Sham Group: Each participant randomly assigned to the "Sham Group" will undergo nine therapy sessions over three weeks using a non functioning invisa-RED Technology Elite device.
|
|---|---|---|
|
Change in Body Fat Percentage
|
-1.7556 Percentage of Body Fat
Interval -2.4273 to -1.0838
|
0.280 Percentage of Body Fat
Interval -0.1194 to 0.6794
|
PRIMARY outcome
Timeframe: In order to determine change over time, the prescribed body measurements will be summed for each participant and recorded before any treatment at first therapy session and recorded again for comparison at the end of three weeks therapy.Population: Number of Sham Group was reduced by a drop out of 4 participants due to schedule conflicts and lack of efficacy.
The prescribed body circumference measurements of the chest, right arm, upper-waist, mid-waist, hips, and right thigh are summed for each participant and recorded.
Outcome measures
| Measure |
Care as Usual Group
n=20 Participants
A randomly selected group of approximately 20 participants who will receive treatment per the prescribed trial protocol using a fully functional invisa-RED Technology Elite device. Treatment protocol is as follows: Participants will undergo nine (9) therapy sessions of 20 minutes each over a three week period; using a singular LLLT protocol setting for pulse (3.5s) and delay (0.2s), however power settings will be based on the participants Fitzpatrick Scale skin type. For skin types i and ii a power setting of 7 will be used, for skin types iii and iv a power setting of 6, for skin types v and vi a power setting of 4 will be employed.
Care as Usual Group: Each participant randomly assigned to the "Care As Usual Group" will undergo nine therapy sessions over three weeks using a fully functioning invisa-RED Technology Elite device.
|
Sham Group
n=15 Participants
A randomly selected group of approximately 20 participants who will receive treatment per the prescribed trial protocol using a non functional invisa-RED Technology Elite device. (The sham device will be disabled and will deliver no low laser light energy during therapy.) Treatment protocol is as follows: Participants will undergo nine (9) therapy sessions of 20 minutes each over a three week period; using a singular protocol setting for pulse (3.5s) and delay (0.2s), however power settings will be based on the participants Fitzpatrick Scale skin type. For skin types i and ii a power setting of 7 will be used, for skin types iii and iv a power setting of 6, for skin types v and vi a power setting of 4 will be employed.
Sham Group: Each participant randomly assigned to the "Sham Group" will undergo nine therapy sessions over three weeks using a non functioning invisa-RED Technology Elite device.
|
|---|---|---|
|
Change in Body Circumference Measurements
|
-10.162500 Inches
Interval -12.193 to -8.1319
|
-3.100000 Inches
Interval -5.8958 to -0.304128
|
PRIMARY outcome
Timeframe: In order to determine change over time, each participants body fat weight will be calculated before any treatment at the first therapy session and calculated again to determine if there exists any change at the end of three weeks therapy.Population: 1. Number of "Care as Usual Group" participants measured was reduced by two morbidly obese participants whose body fat percentage could not be accurately measured. 2. Number of Sham Group was reduced by a drop out of 4 participants due to schedule conflicts and lack of efficacy.
The percentage of body fat for each participant was measured using Bioelectrical Impedance Analysis (BIA). That percentage is then multiplied by the total body weight of the participant in order to calculate the weight in pounds of the participants body fat.
Outcome measures
| Measure |
Care as Usual Group
n=18 Participants
A randomly selected group of approximately 20 participants who will receive treatment per the prescribed trial protocol using a fully functional invisa-RED Technology Elite device. Treatment protocol is as follows: Participants will undergo nine (9) therapy sessions of 20 minutes each over a three week period; using a singular LLLT protocol setting for pulse (3.5s) and delay (0.2s), however power settings will be based on the participants Fitzpatrick Scale skin type. For skin types i and ii a power setting of 7 will be used, for skin types iii and iv a power setting of 6, for skin types v and vi a power setting of 4 will be employed.
Care as Usual Group: Each participant randomly assigned to the "Care As Usual Group" will undergo nine therapy sessions over three weeks using a fully functioning invisa-RED Technology Elite device.
|
Sham Group
n=15 Participants
A randomly selected group of approximately 20 participants who will receive treatment per the prescribed trial protocol using a non functional invisa-RED Technology Elite device. (The sham device will be disabled and will deliver no low laser light energy during therapy.) Treatment protocol is as follows: Participants will undergo nine (9) therapy sessions of 20 minutes each over a three week period; using a singular protocol setting for pulse (3.5s) and delay (0.2s), however power settings will be based on the participants Fitzpatrick Scale skin type. For skin types i and ii a power setting of 7 will be used, for skin types iii and iv a power setting of 6, for skin types v and vi a power setting of 4 will be employed.
Sham Group: Each participant randomly assigned to the "Sham Group" will undergo nine therapy sessions over three weeks using a non functioning invisa-RED Technology Elite device.
|
|---|---|---|
|
Change in Weight of Body Fat
|
-4.5183 Pounds
Standard Deviation 3.42558
|
-.0480 Pounds
Standard Deviation 2.35970
|
Adverse Events
Care as Usual Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sham Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Thomas A. Namynanik - Consultant to invisa-RED Technologies
Vidantis Technologies, Inc
Phone: 404 915-5938
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place