NCT06359145

Brief Summary

The purpose of this study is to predict the CT visual score of emphysema with EIT-based parameters, in order to provide a non-invasive and convenient method for the evaluation of lung structure and physiological and pathological progression of COPD.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2023

Geographic Reach
1 country

1 active site

Status
recruiting

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

April 1, 2023

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

March 30, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 11, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
Last Updated

April 11, 2024

Status Verified

April 1, 2024

Enrollment Period

1.2 years

First QC Date

March 30, 2024

Last Update Submit

April 5, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • The predictive power of EIT and PFT for CT visual scoring of emphysema

    the prediction accuracy between deep machine learning models based on PFT data and EIT data

    1 mounths

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Clinical physicians suspect a patient may have COPD based on symptoms and physical examination, but a definitive diagnosis has not been confirmed through PFTs.

You may qualify if:

  • Clinical physicians suspect a patient may have COPD based on symptoms and physical examination, but a definitive diagnosis has not been confirmed through PFTs.
  • Age \> 20 years, and be able to communicate with doctors.
  • Willing to sign informed consent for the course of the study.

You may not qualify if:

  • Patient refusal of EIT examination.
  • The CT scan information is incomplete, and the interval between the pulmonary function test and the CT scan is more than 180 days.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PLA

Beijing, Beijing Municipality, 100853, China

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Zhimei Duan, doctor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Department of Respiratory and Critical Care Medicine, Chinese PLA General Hospital

Study Record Dates

First Submitted

March 30, 2024

First Posted

April 11, 2024

Study Start

April 1, 2023

Primary Completion

June 1, 2024

Study Completion

August 1, 2024

Last Updated

April 11, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations