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Clinical Trail of Transtek Glass Body Fat Analyzer

NCT01440894 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2011-09-27

No results posted yet for this study

Summary

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. 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. Comparison device: Transtek Glass Body Analyzer, GBF-950 (Predicate Device).
5. Study endpoints: Transtek devices and the predicate device are substantial equivalence.
6. Statistical methodology used: Description of statistical methods.
7. Result: Efficiencies of Transtek devices and predicate device are in the same level.

Conditions

  • Weight
  • Body Fat Disorder
  • Bone Mass

Interventions

DEVICE

Comparison test

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.

Sponsors & Collaborators

  • BTS International

    collaborator OTHER

  • Leo Wang

    lead OTHER

Principal Investigators

  • Stephen Feng, Director · Zhongshan People's Hospital, Guangdong, China

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-02-28
Primary Completion
2011-02-28
Completion
2011-02-28

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01440894 on ClinicalTrials.gov