NCT02784925

Brief Summary

Ultrasound (US) B mode image is an alternative method to measure tissue structure and has proven to be an accurate technique to measure subcutaneous fat thickness. However, pressing the transducer onto the skin with too much force will significantly reduce the subcutaneous adipose tissue thickness. In this study, a force controlled system combined with US transducer was used for 3D subcutaneous fat imaging and reconstruction.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2016

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

May 20, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 27, 2016

Completed
5 days until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
12 months until next milestone

Results Posted

Study results publicly available

June 22, 2017

Completed
Last Updated

June 22, 2017

Status Verified

April 1, 2016

Enrollment Period

1 month

First QC Date

May 20, 2016

Results QC Date

September 18, 2016

Last Update Submit

June 20, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Subcutaneous Fat in Steatosis Patients

    up to 6 months

Study Arms (1)

fatty liver subjects

OTHER

Ultrasound (US) B mode image is an alternative method to measure tissue structure and has proven to be an accurate technique to measure subcutaneous fat thickness.

Device: Ultrasound (US) B mode image

Interventions

Ultrasound (US) B mode image is an alternative method to measure tissue structure and has proven to be an accurate technique to measure subcutaneous fat thickness.

fatty liver subjects

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged between 20-65 adults who are confirmed have fatty liver by echo

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Fatty Liver

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Results Point of Contact

Title
Ming-Shun Wu
Organization
WanFangH

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2016

First Posted

May 27, 2016

Study Start

June 1, 2016

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

June 22, 2017

Results First Posted

June 22, 2017

Record last verified: 2016-04

Data Sharing

IPD Sharing
Will not share