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

Ye Gu

Status: Not yet enrolling

Conditions: Heterogeneous Emphysema

Treatments: Procedure: Transbronchial Endoscopic Thermal Vapor Ablation

Study type: Observational

Funder types: Other

Identifiers

NCT06642038

L23-399

Details and patient eligibility

About

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

Enrollment: 51 estimated patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male or female, age ≥40 and ≤75 years old
2. Heterogeneous emphysema
3. 20% predicted value ≤ FEV1 ≤ 50% predicted value, TLC ≥ 100% predicted value, RV ≥ 150% predicted value, DLCO ≥ 20% predicted value
4. 6-minute walking distance (6MWD) > 140m
5. mMRC index ≥ 2
6. The patients have fully understood the content of the trial and voluntarily signed the informed consent form

Exclusion criteria

1. 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
2. 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
3. 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
4. Receiving morphine derivatives within 4 weeks prior to screening
5. Respiratory tract infection or exacerbation of chronic obstructive pulmonary disease (COPD) within 6 weeks prior to screening
6. 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.
7. 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.
8. Symptoms or abnormal laboratory values suggesting active infection (e.g., fever, elevated white blood cell count, etc.).
9. 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.
10. Patients evaluated by specialists to have highly suspected malignant pulmonary nodules.
11. Women who intend to become pregnant, are pregnant, or are breastfeeding during the study.
12. Patients participating in other drug or medical device clinical trials.
13. The investigator believes the patient has other conditions that make them unsuitable for inclusion in this study.

Trial design

51 participants in 1 patient group

Experimental Group

Treatment:

Procedure: Transbronchial Endoscopic Thermal Vapor Ablation