NCT02971917

Brief Summary

To validate the following theory: "With TRUVIEW ART™ applied a detector's quantitative performance index, MTF(Modulation Transfer Function), is increased 20% or more". This is to examine the effect of the increased MTF index, whether it influences or not the interpreter's preference

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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, 2016

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

November 15, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 23, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

November 23, 2016

Status Verified

November 1, 2016

Enrollment Period

6 months

First QC Date

November 15, 2016

Last Update Submit

November 21, 2016

Conditions

Thoracic Diseases

Keywords

Chest radiographyImage improvementsImage ReconstructionPreprocessingMTF

Outcome Measures

Primary Outcomes (1)

  • Qualitative research using Wilcoxon's signed rank test to compare images produced by test equipment before and after applying TRUVIEW ART (Advanced Reconstruction Tech)

    \- Preference score : Eleven anatomic regions(unobscured lung, hilum, minor fissure, retrocardiac lung, lung projected below the diaphragm (subdiaphragmatic lung), azygoesophageal recess, heart border, rib, proximal airway, thoracic spine, and overall appearance) are evaluated. Each pair of images is ranked on a scale from one to five

    Report composed based on analysis of clinical images accumulated over 6 months

Study Arms (1)

Clinical study of TRUVIEW ART

EXPERIMENTAL

Chest x-ray image acquisition Creation of TRUVIEW ART applied image Comparison of TRUVIEW ART image with original image

Radiation: Chest x-ray image acquisitionRadiation: Creation of TRUVIEW ART applied imageRadiation: Comparison of TRUVIEW ART image with original image

Interventions

Chest x-ray image acquisitionRADIATION

Obtain a digital X-ray chest image of the patient

Clinical study of TRUVIEW ART
Creation of TRUVIEW ART applied imageRADIATION

Application of TRUVIEW ART to the original chest x-ray image to create a new set of TRUVIEW ART applied image. Outcome: 2 versions of chest image 1. Original Chest X-ray (w/o TRUVIEW ART) 2. TRUVIEW ART applied image

Clinical study of TRUVIEW ART
Comparison of TRUVIEW ART image with original imageRADIATION

Comparison of 2 versions of chest image side by side Performance evaluation may consist of detailed categories such as expression of chest structure, visibility level of pulmonary vascular system, etc. For all categories visibility and preference will be scored and each category will be analyzed to point out any statistical difference

Clinical study of TRUVIEW ART

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults of age 20 or higher
  • Person who is able to fully understand the clinical research procedures
  • Signed up agreement form
  • Patient who visits for Chest computed tomography (CT)

You may not qualify if:

  • Subject is pregnant or suspicious of being pregnant
  • Not able or willing to provide Informed Consent, or consent is withdrawn
  • Not able to collect all required case information

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Thoracic Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Officials

  • Jin Mo Goo, M.D.

    Department of Radiology, Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jin Mo Goo, M.D.

CONTACT

82-2-2072-2584jmgoo@plaza.snu.ac.kr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Department of Radiology

Study Record Dates

First Submitted

November 15, 2016

First Posted

November 23, 2016

Study Start

November 1, 2016

Primary Completion

May 1, 2017

Study Completion

May 1, 2017

Last Updated

November 23, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will share

Locations

KR(1)