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Not yet recruiting NCT06642038

Efficacy and Safety of Transbronchial Bronchoscopic Thermal Vapor Ablation (BTVA) in Heterogeneous Emphysema

— Observational Heterogeneous Emphysema

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Transbronchial Endoscopic Thermal Vapor Ablation.
Who it may be relevant to
Registry conditions: Heterogeneous Emphysema. Basic parameters: 40 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Efficacy and Safety of Transbronchial BTVA in Heterogeneous Emphysema: A Prospective, Single-Arm, Multicenter Clinical Study

Overview

Efficacy and Safety of Transbronchial BTVA in Heterogeneous Emphysema: A Prospective, Single-Arm, Multicenter Clinical Study

Interventions

  • Procedure Transbronchial Endoscopic Thermal Vapor Ablation
    Transbronchial Endoscopic Thermal Vapor Ablation

Primary outcome measures

  • The forced expiratory volume in one second (FEV1) is used to assess lung function [Time frame: 6 months]
  • The Saint George's Respiratory Questionnaire-C (SGRQ-C) questionnaire was used to evaluate the value of patients' quality of life. [Time frame: 6 months]
Secondary outcome measures (9)
  • FEV1 is used to assess lung function [Time frame: 12 months]
  • The SGRQ-C questionnaire was used to evaluate the value of patients' quality of life. [Time frame: 12 months]
  • Forced expiratory volume in one second/Forced vital capcacity（FEV1/FVC） were used to assess lung function [Time frame: 6 and 12 months]
  • FVC were used to assess lung function [Time frame: 6 and 12 months]
  • ResidualVolume (RV) were used to assess lung function [Time frame: 6 and 12 months]
  • Total Lung Capacity（TLC） were used to assess lung function [Time frame: 6 and 12 months]
  • 6 minute walking distance (6MWD) was used to assess exercise tolerance [Time frame: 6 and 12 months]
  • Symptom scoring using COPD Assessment Test (CAT), modified Medical Research Council （mMRC） scoring table [Time frame: 6 and 12 months]
  • Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 [Time frame: At surgery and 12 months after surgery]

Eligibility criteria

Inclusion criteria

  • Male or female, age ≥40 and ≤75 years old
  • Heterogeneous emphysema
  • 20% predicted value ≤ FEV1 ≤ 50% predicted value, TLC ≥ 100% predicted value, RV ≥ 150% predicted value, DLCO ≥ 20% predicted value
  • 6-minute walking distance (6MWD) \> 140m
  • mMRC index ≥ 2
  • The patients have fully understood the content of the trial and voluntarily signed the informed consent form

Exclusion criteria

  • Contraindications to bronchoscopy include: myocardial infarction within the past month, active massive hemoptysis, coagulation dysfunction, pregnancy, malignant arrhythmia, severe pulmonary hypertension, extreme systemic failure, and other conditions
  • Concomitant diseases that may significantly increase the risk of complications after BTVA treatment include, but are not limited to: immune system disorders, bleeding disorders, unstable cardiovascular disease, a history of asthma, and alpha-1 antitrypsin deficiency
  • Concomitant medications known to significantly increase the risk of complications after BTVA treatment include, but are not limited to: immunosuppressive drugs (except topical medications), anticoagulants, and antiplatelet drugs
  • Receiving morphine derivatives within 4 weeks prior to screening
  • Respiratory tract infection or exacerbation of chronic obstructive pulmonary disease (COPD) within 6 weeks prior to screening
  • The upper and lower lobes of the other lung have high-grade emphysematous lesions, defined as HRCT showing that the low-density attenuation area (less than -950 Hu) accounts for more than 40% of the total lung volume.
  • The lobe of the lung where the intended treatment segment is located has large bullae (defined as bullae that occupy more than one-third of the lobe) or paralobular septal emphysema.
  • Symptoms or abnormal laboratory values suggesting active infection (e.g., fever, elevated white blood cell count, etc.).
  • Patients who have undergone or plan to undergo lung or chest surgery during this study, including but not limited to lung resection or lung transplantation.
  • Patients evaluated by specialists to have highly suspected malignant pulmonary nodules.
  • Women who intend to become pregnant, are pregnant, or are breastfeeding during the study.
  • Patients participating in other drug or medical device clinical trials.
  • The investigator believes the patient has other conditions that make them unsuitable for inclusion in this study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06642038 · L23-399

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗