Heterogeneous EmphysemaNCT06642038
Efficacy and Safety of Transbronchial Bronchoscopic Thermal Vapor Ablation (BTVA) in Heterogeneous Emphysema
An observational study of Heterogeneous Emphysema, run by Ye Gu.
Trial summary
Efficacy and Safety of Transbronchial BTVA in Heterogeneous Emphysema: A Prospective, Single-Arm, Multicenter Clinical Study Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Heterogeneous Emphysema
- What is being tested?
- Transbronchial Endoscopic Thermal Vapor Ablation
- Type of treatment
- Surgery or procedure
- How many people
- 51 participants
- Where
- No sites listed yet
- Study dates
- 13 Oct 2024to 1 Sep 2026
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who are planning to receive BTVA for heterogeneous emphysema
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Efficacy and Safety of Transbronchial BTVA in Heterogeneous Emphysema: A Prospective, Single-Arm, Multicenter Clinical Study
Efficacy and Safety of Transbronchial BTVA in Heterogeneous Emphysema: A Prospective, Single-Arm, Multicenter Clinical Study
- Conditions
- Heterogeneous Emphysema
- Being tested
- Transbronchial Endoscopic Thermal Vapor Ablation
- Keywords
- BTVA, Heterogeneous emphysema, Bronchoscopy, Efficacy and Safety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transbronchial Endoscopic Thermal Vapor AblationProcedure or surgery
Transbronchial Endoscopic Thermal Vapor Ablation
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Not described Receives: Procedure: Transbronchial Endoscopic Thermal Vapor Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 6 months
Secondary outcomes (9)
FEV1 is used to assess lung function
Improvement in FEV1 12 months after the first treatment.
Measured: 12 months
The SGRQ-C questionnaire was used to evaluate the value of patients' quality of life.
Improvement in SGRQ-C 12 months after the first 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.
Measured: 12 months
Forced expiratory volume in one second/Forced vital capcacity（FEV1/FVC） were used to assess lung function
Improvement in FEV1/FVC compared to baseline at 6 and 12 months after the first treatment
Measured: 6 and 12 months
FVC were used to assess lung function
Improvement in FVC compared to baseline at 6 and 12 months after the first treatment
Measured: 6 and 12 months
ResidualVolume (RV) were used to assess lung function
Improvement in RV compared to baseline at 6 and 12 months after the first treatment
Measured: 6 and 12 months
Total Lung Capacity（TLC） were used to assess lung function
Improvement in TLC compared to baseline at 6 and 12 months after the first treatment
Measured: 6 and 12 months
6 minute walking distance (6MWD) was used to assess exercise tolerance
Improvement in exercise tolerance compared to baseline at 6 and 12 months after the first treatment: 6MWD.
Measured: 6 and 12 months
Symptom scoring using COPD Assessment Test (CAT), modified Medical Research Council （mMRC） scoring table
Improvement in symptom scores compared to baseline at 6 and 12 months after the first treatment: CAT, mMRC. The CAT score is a comprehensive assessment of symptoms, ranging from 0 to 40 points. A score of 10 or above indicates a higher number of symptoms. Scores between 0 and 10 reflect a mild impact, 11 to 20 indicate a moderate impact, 21 to 30 represent a severe impact, and 31 to 40 signify a very severe impact on the patient's condition. The mMRC score is a scale used to assess the degree of breathlessness, with a range from 0 to 4. A higher score indicates greater severity of symptoms. A score of 0 reflects no breathlessness except with strenuous exercise, 1 indicates breathlessness when hurrying on level ground or walking up a slight hill, 2 represents breathlessness causing the patient to walk slower than people of the same age or having to stop for breath when walking at their own pace, 3 indicates stopping for breath after walking about 100 meters or after a few minutes on le
Measured: 6 and 12 months
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
All adverse events during surgery and postoperative follow-up were recorded and evaluated according to CTCAE V5.0. The relevance of these events to BTVA treatment was assessed, and the incidence of adverse events and serious adverse events related to BTVA treatment was calculated.
Measured: At surgery and 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start13 Oct 2024 (estimated)
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heterogeneous EmphysemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 51 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Ye Gu
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Sponsor-investigator, Ye Gu, Shanghai Pulmonary Hospital, Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06642038
- Sponsor's protocol ID
- L23-399
- Status last verified
- Oct 2024
- First submitted
- 29 Sep 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The dataset produced during this study is available upon request from the corresponding author (drsymons@outlook.com).
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Transbronchial BTVA in Heterogeneous Emphysema: A Prospective, Single-Arm, Multicenter Clinical Study
- ClinicalTrials.gov ID
- NCT06642038
- Acronym / sponsor ID
- L23-399
- Conditions
- Heterogeneous Emphysema
- Keywords
- BTVA, Heterogeneous emphysema, Bronchoscopy, Efficacy and Safety
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 51 participants (estimated)
- Lead sponsor
- Ye GuUniversity, hospital or other
- 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
- Study start
- 13 Oct 2024 (estimated)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 15 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Efficacy and Safety of Transbronchial BTVA in Heterogeneous Emphysema: A Prospective, Single-Arm, Multicenter Clinical Study
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | – | Procedure: Transbronchial Endoscopic Thermal Vapor Ablation |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are planning to receive BTVA for heterogeneous emphysema
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transbronchial Endoscopic Thermal Vapor AblationTransbronchial Endoscopic Thermal Vapor Ablation | Procedure or surgery | Experimental Group |
Primary outcome
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.
9 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Individual participant dataSharing planned: No. The dataset produced during this study is available upon request from the corresponding author (drsymons@outlook.com).
Related trials for Heterogeneous Emphysema
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Heterogeneous Emphysema, run by Ye Gu.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ye Gu (8613817624060, drsymons@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The forced expiratory volume in one second (FEV1) is used to assess lung function (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.