Trial Outcomes & Findings for Low-Frequency, High-Intensity Ultrasound for Waist Circumference Reduction (NCT NCT04206384)
NCT ID: NCT04206384
Last Updated: 2021-08-23
Results Overview
Change in measurable circumference of the patient's abdominal area from Baseline to immediately after the 4-week follow-up assessment (approximately 6 weeks from Baseline).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
52 participants
Primary outcome timeframe
The difference between the circumference measurement immediately prior to the first treatment (Baseline) to immediately after the 4-week follow-up assessment (approximately 6 weeks from Baseline).
Results posted on
2021-08-23
Participant Flow
Participant milestones
| Measure |
Treatment Group
Each patient shall receive a total of 3 treatments. Each treatment shall consist of applying the ultrasound device for 30 minutes to the skin surface, working the device methodically over the abdominal area. The device shall be set at the maximum emission level, have an intensity of approximately 1.0 watt/cm\^2.
Ultrasound: Ultimate Contour Body Sculpting Device
|
|---|---|
|
Overall Study
STARTED
|
52
|
|
Overall Study
COMPLETED
|
42
|
|
Overall Study
NOT COMPLETED
|
10
|
Reasons for withdrawal
| Measure |
Treatment Group
Each patient shall receive a total of 3 treatments. Each treatment shall consist of applying the ultrasound device for 30 minutes to the skin surface, working the device methodically over the abdominal area. The device shall be set at the maximum emission level, have an intensity of approximately 1.0 watt/cm\^2.
Ultrasound: Ultimate Contour Body Sculpting Device
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
8
|
|
Overall Study
Adverse Event
|
2
|
Baseline Characteristics
Low-Frequency, High-Intensity Ultrasound for Waist Circumference Reduction
Baseline characteristics by cohort
| Measure |
Treatment Group
n=52 Participants
Each patient shall receive a total of 3 treatments. Each treatment shall consist of applying the ultrasound device for 30 minutes to the skin surface, working the device methodically over the abdominal area. The device shall be set at the maximum emission level, have an intensity of approximately 1.0 watt/cm\^2.
Ultrasound: Ultimate Contour Body Sculpting Device
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
50 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
42 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
40 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
52 participants
n=5 Participants
|
|
Waist Circumference
|
40.95 Inches
STANDARD_DEVIATION 5.32 • n=5 Participants
|
|
Body Mass Index
|
29.36 kg/m2
STANDARD_DEVIATION 4.23 • n=5 Participants
|
PRIMARY outcome
Timeframe: The difference between the circumference measurement immediately prior to the first treatment (Baseline) to immediately after the 4-week follow-up assessment (approximately 6 weeks from Baseline).Population: Participants who completed treatment process and follow-up visits as described.
Change in measurable circumference of the patient's abdominal area from Baseline to immediately after the 4-week follow-up assessment (approximately 6 weeks from Baseline).
Outcome measures
| Measure |
Treatment Group
n=42 Participants
Each patient shall receive a total of 3 treatments. Each treatment shall consist of applying the ultrasound device for 30 minutes to the skin surface, working the device methodically over the abdominal area. The device shall be set at the maximum emission level, have an intensity of approximately 1.0 watt/cm\^2.
Ultrasound: Ultimate Contour Body Sculpting Device
|
|---|---|
|
Waist Circumference Change
|
-2.03 Inches
Standard Deviation 0.77
|
SECONDARY outcome
Timeframe: Assessed during and immediately after (up to 15 minutes after use ceased) each application of the device, and at 1 week, 4 weeks, and 12 weeks post-treatment.Population: Assessment of participant during or after any treatment application.
Incidence of pain during each application of the device and/or immediately following each application of the device (up to 15 minutes after use of the device ceased).
Outcome measures
| Measure |
Treatment Group
n=52 Participants
Each patient shall receive a total of 3 treatments. Each treatment shall consist of applying the ultrasound device for 30 minutes to the skin surface, working the device methodically over the abdominal area. The device shall be set at the maximum emission level, have an intensity of approximately 1.0 watt/cm\^2.
Ultrasound: Ultimate Contour Body Sculpting Device
|
|---|---|
|
Number of Participants With Pain
|
3 participants
|
Adverse Events
Treatment Group
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment Group
n=52 participants at risk
Each patient shall receive a total of 3 treatments. Each treatment shall consist of applying the ultrasound device for 30 minutes to the skin surface, working the device methodically over the abdominal area. The device shall be set at the maximum emission level, have an intensity of approximately 1.0 watt/cm\^2.
Ultrasound: Ultimate Contour Body Sculpting Device
|
|---|---|
|
Ear and labyrinth disorders
Ringing in the ears
|
13.5%
7/52 • Number of events 7 • Collection and follow-up occurred over a space of up to 8 weeks.
No difference in definition. Event collection consisted of enquiring of the participant any observations following application of the device. Participants were to keep a study diary and document any observations. Investigator reviewed study diaries and identified any comments that constitute an adverse event.
|
|
Skin and subcutaneous tissue disorders
Skin Rash
|
1.9%
1/52 • Number of events 1 • Collection and follow-up occurred over a space of up to 8 weeks.
No difference in definition. Event collection consisted of enquiring of the participant any observations following application of the device. Participants were to keep a study diary and document any observations. Investigator reviewed study diaries and identified any comments that constitute an adverse event.
|
|
Gastrointestinal disorders
Constipation
|
1.9%
1/52 • Number of events 1 • Collection and follow-up occurred over a space of up to 8 weeks.
No difference in definition. Event collection consisted of enquiring of the participant any observations following application of the device. Participants were to keep a study diary and document any observations. Investigator reviewed study diaries and identified any comments that constitute an adverse event.
|
|
Skin and subcutaneous tissue disorders
Inflammation / Heat Sensation
|
9.6%
5/52 • Number of events 5 • Collection and follow-up occurred over a space of up to 8 weeks.
No difference in definition. Event collection consisted of enquiring of the participant any observations following application of the device. Participants were to keep a study diary and document any observations. Investigator reviewed study diaries and identified any comments that constitute an adverse event.
|
|
Renal and urinary disorders
Fatty Urine
|
1.9%
1/52 • Number of events 1 • Collection and follow-up occurred over a space of up to 8 weeks.
No difference in definition. Event collection consisted of enquiring of the participant any observations following application of the device. Participants were to keep a study diary and document any observations. Investigator reviewed study diaries and identified any comments that constitute an adverse event.
|
|
Ear and labyrinth disorders
Vertigo
|
1.9%
1/52 • Number of events 1 • Collection and follow-up occurred over a space of up to 8 weeks.
No difference in definition. Event collection consisted of enquiring of the participant any observations following application of the device. Participants were to keep a study diary and document any observations. Investigator reviewed study diaries and identified any comments that constitute an adverse event.
|
|
Nervous system disorders
Headache
|
1.9%
1/52 • Number of events 1 • Collection and follow-up occurred over a space of up to 8 weeks.
No difference in definition. Event collection consisted of enquiring of the participant any observations following application of the device. Participants were to keep a study diary and document any observations. Investigator reviewed study diaries and identified any comments that constitute an adverse event.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place