NCT01440894

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.DUT(Device Under Test): Transtek Glass Body Fat Analyzer, Model: GBF-733-W1, GBF-1012, BF-1039, BF-1041-A, and GBF-950-D.
  4. 4.Comparison device: Transtek Glass Body Analyzer, GBF-950 (Predicate Device).
  5. 5.Study endpoints: Transtek devices and the predicate device are substantial equivalence.
  6. 6.Statistical methodology used: Description of statistical methods.
  7. 7.Result: Efficiencies of Transtek devices and predicate device are in the same level.

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 all trials

Timeline
Completed

Started Feb 2011

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

February 1, 2011

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 25, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 27, 2011

Completed
Last Updated

September 27, 2011

Status Verified

September 1, 2011

Enrollment Period

Same day

First QC Date

September 25, 2011

Last Update Submit

September 25, 2011

Conditions

WeightBody Fat DisorderBone Mass

Keywords

weightbody fattotal body waterbone massmuscle mass

Outcome Measures

Primary Outcomes (1)

  • Verify the accuracy of measure functions of device

    Verify the functions and efficiency of these devices compare with a specified product.

    8 days

Study Arms (1)

Body Analysis

Device: Comparison test

Interventions

Comparison testDEVICE

Reference Device: Transtek Glass Body Analyzer, GBF-950, accuracy: ±0.1kg and range: 0-180kg. DUT(Device Under Test): Transtek Glass Body Fat Analyzer, Model: GBF-733-W1, GBF-1012, BF-1039, BF-1041-A, and GBF-950-D.

Also known as: Brand name: Transtek
Body Analysis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The subject population included patients whose age is above 18 years old. Male or Female.

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)

Zhongshan City People's Hospital

Zhongshan, Guangdong, 528403, China

Location

Related Links

MeSH Terms

Conditions

Body Weight

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Stephen Feng, Director

    Zhongshan People's Hospital, Guangdong, China

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Team leader

Study Record Dates

First Submitted

September 25, 2011

First Posted

September 27, 2011

Study Start

February 1, 2011

Primary Completion

February 1, 2011

Study Completion

February 1, 2011

Last Updated

September 27, 2011

Record last verified: 2011-09

Locations

CN(1)