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Clinical Test for Transtek Glass Body Analyzer

NCT01296048 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 74

Last updated 2011-12-23

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: Transtek Glass Body Analyzer, Model: GBF-830, GBF-835, GBF-950, and SA-15.
4. Comparison device: Scaleman Body Fat Scales, FS-148BW1 (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

Scaleman Body Fat Scales, FS-148BW1, accuracy: ±0.1kg and range: 0-180kg.

Sponsors & Collaborators

  • West China Hospital

    collaborator OTHER

  • Leo Wang

    lead OTHER

Principal Investigators

  • Guoqing Li, Director · Wuhou District Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2010-12-31
Completion
2010-12-31

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 NCT01296048 on ClinicalTrials.gov