NCT01763775

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-1251-B, BF-1255-B, BF-1256-B, and GBF-1257-B.
  4. 4.Comparison device: Transtek, Glass Body Fat Analyzer, GBF-950-D.
  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
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2012

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

October 1, 2012

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 5, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 9, 2013

Completed
Last Updated

January 9, 2013

Status Verified

January 1, 2013

Enrollment Period

Same day

First QC Date

January 5, 2013

Last Update Submit

January 7, 2013

Conditions

WeightBody Fat DisorderBone Mass

Keywords

weighttotal body waterbody fatmuscle massbone mass

Outcome Measures

Primary Outcomes (1)

  • BMI (Body Mass Index)

    Body Fat, Total Body Water, Muscle Mass, Bone Mass

    5 Day

Secondary Outcomes (1)

  • Weight

    5 Days

Study Arms (2)

Transtek 125X

EXPERIMENTAL

Which measured by DUT (Transtek 125X): GBF-1251-B, BF-1255-B, BF-1256-B, GBF-1257-B.

Device: Transtek 125XDevice: Transtek 950D

Transtek 950D

EXPERIMENTAL

Measured by Reference (Transtek 950D): GBF-950-D.

Device: Transtek 125XDevice: Transtek 950D

Interventions

Transtek 125XDEVICE

Measuring weight, total body water, body fat, muscle mass, and bone mass. Measure each participants by Transtek 125X (GBF-1251-B, BF-1255-B, BF-1256-B, GBF-1257-B).

Transtek 125XTranstek 950D
Transtek 950DDEVICE

Measuring weight, total body water, body fat, muscle mass, and bone mass. Measure each participants by Transtek 950D (GBF-950-D).

Transtek 125XTranstek 950D

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • male,female

You may not qualify if:

  • below 18 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 5, 2013

First Posted

January 9, 2013

Study Start

October 1, 2012

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

January 9, 2013

Record last verified: 2013-01

Locations

CN(1)