Body Fat Disorder Clinical Trial
Official title:
Verify the Functions and Efficiency of Transtek (Trade Mark) Body Fat Analyzer, GBF-1251-B, BF-1255-B, BF-1256-B, and GBF-1257-B
The clinical protocol of the clinical testing of this device:
1. Objective of the test: To verify the functions and efficiency of devices.
2. Test methods and procedures: Comparison Test.
3. Device Under Test (DUT): Transtek Body Fat Analyzer, Model: GBF-1251-B, BF-1255-B,
BF-1256-B, and GBF-1257-B.
4. Comparison device: Transtek, Glass Body Fat Analyzer, GBF-950-D.
5. Study endpoints: DUT and the comparison device are substantial equivalence.
6. Statistical methodology used: Description of statistical methods.
1. Test Purpose:
The aim of clinical test is to collect weight, body fat, total body water, bone mass,
and muscle mass reading value which measured by DUT and reference device.
2. Target Subject:
The subject database shall contain at least 25 male and 25 female subjects and all
above 18 years old.
3. Test procedures:
1. Record the name, age, gender, and height of each subject.
2. Let subject seated calmly for two minutes before test, dry the feet.
3. Use device to measure weight, body fat, total body water, bone mass, and muscle
mass; record reading value.
4. For each subject, repeat 3) to get 3 pairs measurements.
5. Repeat step 1) to 4) for every device (DUT: GBF-1251-B, BF-1255-B, BF-1256-B, and
GBF-1257-B; and reference device: GBF-950-D).
6. Repeat step 1) to 5) for each subject.
4. Note:
1. No motion and speaking are allowed during the measurement.
2. All DUT use the same algorithms and contact the patient at the same body locations
(feet), and operate on the same frequency.
3. Test environment: Temperature: 22±1℃; Relative humidity: 40~70%.
;
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01686841 -
A Pilot Clinical Trial Investigating the Effect of Cutaneous Cooling on Sebum Production
|
N/A | |
Completed |
NCT04340388 -
Contribution of Dolutegravir to Obesity and Cardiovascular Disease
|
Phase 4 | |
Completed |
NCT02554760 -
Bilateral; Flank Study With Crown Cooling Insert
|
N/A | |
Completed |
NCT04142450 -
CoolSculpting® the Upper Arms and Inner Thighs in Participants of Chinese Descent (XinCOOL)
|
N/A | |
Active, not recruiting |
NCT03304925 -
CoolSculpting the Flanks
|
N/A | |
Completed |
NCT02941146 -
DualSculpting the Abdomen Using CoolSculpting
|
N/A | |
Completed |
NCT01859091 -
Pilot Study on the Submental Area
|
N/A | |
Completed |
NCT05558488 -
The Effect of a Meatless,Keto Restrictive Diet on Body Composition,Strength Capacity,Oxidative Stress,Immune Response
|
N/A | |
Completed |
NCT03738891 -
CoolSculpting and EMS for the Abdomen
|
N/A | |
Withdrawn |
NCT04199806 -
Retrospective Study of Patient Surveys
|
N/A | |
Completed |
NCT01728857 -
Tissue Optimization on Cryolipolysis Procedures for Fat Layer Reduction
|
N/A | |
Completed |
NCT01296048 -
Clinical Test for Transtek Glass Body Analyzer
|
N/A | |
Completed |
NCT02324816 -
Fat Layer Reduction in the Lateral Thighs Using CoolSculpting
|
N/A | |
Recruiting |
NCT04876118 -
Effects on Cellulite Appearance
|
N/A | |
Completed |
NCT02298322 -
Subcutaneous Fat Reduction in the Submental Area
|
N/A | |
Completed |
NCT01600638 -
Non-Invasive Reduction of Fat in the Flanks of Patients With Sharp Body Curvature
|
N/A | |
Completed |
NCT03510598 -
Submental Study (Sequential Treatment Approach)
|
Phase 4 | |
Completed |
NCT01814007 -
Multiple CoolSculpting Treatment Study
|
N/A | |
Completed |
NCT01579487 -
Extended Follow-Up Study for Subjects Who Participated in 2010 Study
|
N/A | |
Enrolling by invitation |
NCT04506307 -
CoolSculpting System
|
N/A |