NCT02345109

Brief Summary

The clinical protocol of the clinical testing of this device:

  1. 1.Objective of the test: To verify the functions and efficiency of devices.
  2. 2.Test methods and procedures: Comparison Test.
  3. 3.Device Under Test (DUT): Transtek Body Fat Analyzer, Model: GBF-835-N2, GBF-835-N2 Plus, LS202-B1, LS202-B1 Plus, LS206-E1, LS206-E1 Plus, GBF-1251-B1, and GBF-1251-B1 Plus.
  4. 4.Comparison device: TRANSTEK GBF-1251-B and Tanita BC-533.
  5. 5.Study endpoints: DUT and the comparison device are substantial equivalence.
  6. 6.Statistical methodology used: Description of statistical methods.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 19, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 26, 2015

Completed
Last Updated

January 26, 2015

Status Verified

January 1, 2015

Enrollment Period

Same day

First QC Date

January 19, 2015

Last Update Submit

January 22, 2015

Conditions

WeightBody Fat Disorder

Keywords

weighttotal body waterbody fatmuscle massbone massBMIvisceral fatcalories

Outcome Measures

Primary Outcomes (1)

  • BMI (Body Mass Index)

    Body Fat, Total Body Water, Muscle Mass, Bone Mass, BMI, calorie, and visceral fat.

    5 Days

Secondary Outcomes (1)

  • Weight

    1 Day

Study Arms (2)

Transtek DUT

EXPERIMENTAL

Which measured by DUT: GBF-835-N2, GBF-835-N2 Plus, LS202-B1, Ls202-B1 Plus, LS206-E1, LS206-E1 Plus, GBF-1251-B1, and GBF-1251-B1 Plus.

Device: Transtek DUTDevice: Reference

Reference

EXPERIMENTAL

Measured by Reference: TRANSTEK® Glass Body Fat Analyzer GBF-1251-B, Tanita® Body Composition Monitor BC-533.

Device: Transtek DUTDevice: Reference

Interventions

Transtek DUTDEVICE

Measuring weight, total body water, body fat, muscle mass, bone mass, BMI, visceral fat, and calorie. Measure each participants by Transtek DUT.

ReferenceTranstek DUT
ReferenceDEVICE

Measuring weight, total body water, body fat, muscle mass, bone mass, BMI, visceral fat, and calorie. Measure each participants by Reference.

ReferenceTranstek DUT

Eligibility Criteria

Age10 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Male, female

You may not qualify if:

  • Below 10 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wuhou District Hospital

Chengdu, Sichuan, 610041, China

Location

MeSH Terms

Conditions

Body Weight

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Guoqing Li, Director

    Wuhou District Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Team Leader

Study Record Dates

First Submitted

January 19, 2015

First Posted

January 26, 2015

Study Start

December 1, 2014

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

January 26, 2015

Record last verified: 2015-01

Locations

CN(1)