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

NCT06642038 | Not Yet Recruiting DMC

• 1 other identifier: L23-399
• Study Type: observational
• Target: 51
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Heterogeneous Emphysema

Keywords

BTVA; Heterogeneous emphysema; Bronchoscopy; Efficacy and Safety

Outcome Measures

Primary Outcomes (2)

• The forced expiratory volume in one second (FEV1) is used to assess lung function

  Evaluate the improvement in FEV1 from baseline to 6 months after BTVA treatment.

  6 months

• The Saint George's Respiratory Questionnaire-C (SGRQ-C) questionnaire was used to evaluate the value of patients' quality of life.

  Evaluate the improvement in SGRQ-C questionnaire from baseline to 6 months after BTVA treatment. The total score of SGRQ-C questionnaire usually ranges from 0 to 100, with 0 representing the best condition and 100 representing the worst condition.

  6 months

Secondary Outcomes (9)

• FEV1 is used to assess lung function

  12 months

• The SGRQ-C questionnaire was used to evaluate the value of patients' quality of life.

  12 months

• Forced expiratory volume in one second/Forced vital capcacity（FEV1/FVC） were used to assess lung function

  6 and 12 months

• FVC were used to assess lung function

  6 and 12 months

• ResidualVolume (RV) were used to assess lung function

  6 and 12 months

Study Arms (1)

Experimental Group

Procedure: Transbronchial Endoscopic Thermal Vapor Ablation

Interventions

Transbronchial Endoscopic Thermal Vapor Ablation PROCEDURE

Transbronchial Endoscopic Thermal Vapor Ablation

Experimental Group

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients who are planning to receive BTVA for heterogeneous emphysema

You may qualify if:

• Male or female, age ≥40 and ≤75 years old
• Heterogeneous emphysema
• % predicted value ≤ FEV1 ≤ 50% predicted value, TLC ≥ 100% predicted value, RV ≥ 150% predicted value, DLCO ≥ 20% predicted value
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ye Gu: lead
• Ruijin Hospital: collaborator
• First Hospital of China Medical University: collaborator
• The First Affiliated Hospital of Zhengzhou University: collaborator
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: collaborator
• Shandong Provincial Public Health Clinical Center: collaborator
• First Affiliated Hospital, Sun Yat-Sen University: collaborator
• Zhongda Hospital: collaborator
• Jiangxi Provincial People's Hopital: collaborator
• Shenzhen Baoan District People 's Hospital: collaborator
• Fifth Affiliated Hospital, Sun Yat-Sen University: collaborator
• First Affiliated Hospital of Chongqing Medical University: collaborator

Central Study Contacts

Ye Gu

CONTACT

8613817624060; drsymons@outlook.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 29, 2024
• First Posted: October 15, 2024
• Study Start: October 13, 2024
• Primary Completion: September 1, 2025
• Study Completion (Estimated): September 1, 2026
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share