---
title: Efficacy and Safety of Transbronchial Bronchoscopic Thermal Vapor Ablation (BTVA) in Heterogeneous Emphysema
nct_id: NCT06642038
overall_status: NOT_YET_RECRUITING
sponsor: Ye Gu
study_type: OBSERVATIONAL
primary_condition: Heterogeneous Emphysema
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT06642038.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT06642038"
ct_last_update_post_date: 2024-10-15
last_seen_at: "2026-05-12T06:43:50.185Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Efficacy and Safety of Transbronchial Bronchoscopic Thermal Vapor Ablation (BTVA) in Heterogeneous Emphysema

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

**NCT ID:** [NCT06642038](https://clinicaltrials.gov/study/NCT06642038)

## Key Facts

- **Status:** NOT_YET_RECRUITING
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 51
- **Lead Sponsor:** Ye Gu
- **Collaborators:** Ruijin Hospital, First Hospital of China Medical University, The First Affiliated Hospital of Zhengzhou University, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Shandong Provincial Public Health Clinical Center, First Affiliated Hospital, Sun Yat-Sen University, Zhongda Hospital, Jiangxi Provincial People's Hopital, Shenzhen Baoan District People 's Hospital, Fifth Affiliated Hospital, Sun Yat-Sen University, First Affiliated Hospital of Chongqing Medical University
- **Conditions:** Heterogeneous Emphysema
- **Start Date:** 2024-10-13
- **Completion Date:** 2026-09-01
- **CT.gov Last Update:** 2024-10-15

## Brief Summary

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

## Eligibility

- **Minimum age:** 40 Years
- **Maximum age:** 75 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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.
```

## Arms

- **Experimental Group**

## Interventions

- **Transbronchial Endoscopic Thermal Vapor Ablation** (PROCEDURE) — Transbronchial Endoscopic Thermal Vapor Ablation

## Primary Outcomes

- **The forced expiratory volume in one second (FEV1) is used to assess lung function** _(time frame: 6 months)_ — Evaluate the improvement in FEV1 from baseline to 6 months after BTVA treatment.
- **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)_ — 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.

## Secondary Outcomes

- **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)_

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT06642038*  
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