NCT05774730

Brief Summary

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.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2023

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

First Submitted

Initial submission to the registry

March 6, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 20, 2023

Completed
6 days until next milestone

Study Start

First participant enrolled

March 26, 2023

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

March 21, 2023

Status Verified

March 1, 2023

Enrollment Period

1.8 years

First QC Date

March 6, 2023

Last Update Submit

March 17, 2023

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (4)

  • Therapeutic effect of lung volume reduction surgery

    Lung CT

    1 month after bronchoscopic valve lung volume reduction

  • Therapeutic effect of lung volume reduction surgery

    Lung CT

    3 months after bronchoscopic valve lung volume reduction

  • Therapeutic effect of lung volume reduction surgery

    Lung CT

    6 months after bronchoscopic valve lung volume reduction

  • the integrity of interlobar fissure

    Emphysema quantitative analysis softwarebased on chest image AI technology, artificial analysis and imported Chartis detection system

    Before bronchoscopic valve lung volume reduction

Study Arms (3)

Emphysema quantitative analysis softwarebased on chest image AI technology

Other: Emphysema quantitative analysis software based on chest image AI technology

artificial analysis

Other: artificial analysis of chest image

imported Chartis detection system

Procedure: imported Chartis detection system

Interventions

Emphysema quantitative analysis software based on chest image AI technologyOTHER

The participants would undergo lung CT, and the integrity of interlobar fissure will be quantitatively analyses by software based on chest image AI technology.

Emphysema quantitative analysis softwarebased on chest image AI technology
artificial analysis of chest imageOTHER

The participants would undergo lung CT, and the integrity of interlobar fissure will be artificially analyses.

artificial analysis
imported Chartis detection systemPROCEDURE

The participants would undergo imported Chartis detection system.

imported Chartis detection system

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

chronic obstructive pulmonary diseases

You may qualify if:

  • 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

You may not qualify if:

  • PaCO2\>8.0 kPa, or PaO2\<6.0 kPa
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 6, 2023

First Posted

March 20, 2023

Study Start

March 26, 2023

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

March 21, 2023

Record last verified: 2023-03