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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 26, 2023

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2024

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 6, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 16, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 20, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 21, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 17, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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