Evaluation of the Effectiveness of Predicting the Integrity of Interlobar Fissures Based on Chest Image AI Technology

March 17, 2023 updated by: Gang Hou, China-Japan Friendship Hospital

The goal of observational study is to evaluate effectiveness of predicting the integrity of interlobar fissures based on chest image AI technology in patients with Chronic Obstructive Pulmonary Disease who will undergo lung volume reduction surgery with endobronchial valve implantation. The main question it aims to answer is: evaluation of the effectiveness of predicting the integrity of interlobar fissures based on chest image AI technology.

Participants will be evaluated by lung CT (quantitative analysis based on chest image AI technology and artificial analysis) and imported Chartis detection system.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

40

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

chronic obstructive pulmonary diseases

Description

Inclusion Criteria:

  • Patients with chronic obstructive pulmonary disease who meet the GOLD diagnostic criteria
  • FEV1 ≤ 45% pred and FEV1/FVC<70%
  • TLC>100% pred and RV>175% pred
  • CAT≥18
  • >50% of emphysema destruction
  • Smoking prohibition>6 months
  • Sign the informed consent form

Exclusion Criteria:

  • PaCO2>8.0 kPa, or PaO2<6.0 kPa
  • 6-minute walking test<160m
  • Obvious chronic bronchitis, bronchiectasis or other infectious lung diseases
  • Three hospitalizations due to pulmonary infection in the past 12 months before the baseline assessment
  • Previous lobectomy, LVRS or lung transplantation
  • LVEF<45% and or RVSP>50mmHg
  • Anticoagulant therapy that cannot be stopped before surgery
  • The patient has obvious immune deficiency
  • Participated in other lung drug studies within 30 days before this study
  • Pulmonary nodules requiring intervention
  • Any disease or condition that interferes with the completion of the initial or subsequent assessment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Emphysema quantitative analysis softwarebased on chest image AI technology
Other: Emphysema quantitative analysis software based on chest image AI technology
The participants would undergo lung CT, and the integrity of interlobar fissure will be quantitatively analyses by software based on chest image AI technology.
artificial analysis
Other: artificial analysis of chest image
The participants would undergo lung CT, and the integrity of interlobar fissure will be artificially analyses.
imported Chartis detection system
Procedure: imported Chartis detection system
The participants would undergo imported Chartis detection system.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the integrity of interlobar fissure
Time Frame: Before bronchoscopic valve lung volume reduction
Emphysema quantitative analysis softwarebased on chest image AI technology, artificial analysis and imported Chartis detection system
Before bronchoscopic valve lung volume reduction
Therapeutic effect of lung volume reduction surgery
Time Frame: 1 month after bronchoscopic valve lung volume reduction
Lung CT
1 month after bronchoscopic valve lung volume reduction
Therapeutic effect of lung volume reduction surgery
Time Frame: 3 months after bronchoscopic valve lung volume reduction
Lung CT
3 months after bronchoscopic valve lung volume reduction
Therapeutic effect of lung volume reduction surgery
Time Frame: 6 months after bronchoscopic valve lung volume reduction
Lung CT
6 months after bronchoscopic valve lung volume reduction

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

China-Japan Friendship Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 26, 2023

Primary Completion (Anticipated)

December 31, 2024

Study Completion (Anticipated)

December 31, 2024

Study Registration Dates

First Submitted

March 6, 2023

First Submitted That Met QC Criteria

March 16, 2023

First Posted (Actual)

March 20, 2023

Study Record Updates

Last Update Posted (Actual)

March 21, 2023

Last Update Submitted That Met QC Criteria

March 17, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-NHLHCRF-LX-01-0202-2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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