NCT01296048

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: Transtek Glass Body Analyzer, Model: GBF-830, GBF-835, GBF-950, and SA-15.
  4. 4.Comparison device: Scaleman Body Fat Scales, FS-148BW1 (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
74

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2010

Shorter than P25 for all trials

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

November 1, 2010

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 12, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 15, 2011

Completed
Last Updated

December 23, 2011

Status Verified

December 1, 2011

Enrollment Period

1 month

First QC Date

February 12, 2011

Last Update Submit

December 22, 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.

    10 days

Study Arms (1)

Body Analysis

Device: Comparison test

Interventions

Comparison testDEVICE

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

Also known as: Brand names: Scaleman, Serial numbers: SBFS1002-351, Code name: FS-148BW1
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)

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

Study Record Dates

First Submitted

February 12, 2011

First Posted

February 15, 2011

Study Start

November 1, 2010

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

December 23, 2011

Record last verified: 2011-12

Locations

CN(1)