An observational study in Heterogeneous Emphysema, sponsored by Ye Gu. Not yet recruiting. Open to participants aged 40 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-10-15.
Sponsored by Ye Gu · Observational
Efficacy and Safety of Transbronchial BTVA in Heterogeneous Emphysema: A Prospective, Single-Arm, Multicenter Clinical Study
382 studies on the registry are indexed under Emphysema; 59 are open to participants now.
This study's planned enrollment of 51 is below the median of 131 across 111 observational studies indexed under Emphysema.
Browse Emphysema studies →This is the only study on the registry with Ye Gu as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Patients who are planning to receive BTVA for heterogeneous emphysema
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Procedure: Transbronchial Endoscopic Thermal Vapor Ablation
Transbronchial Endoscopic Thermal Vapor Ablation
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.
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.
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.
Time frame: 6 months
FEV1 is used to assess lung function
Improvement in FEV1 12 months after the first treatment.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: At surgery and 12 months after surgery
No study locations are listed for this record.
Plan to share: No — The dataset produced during this study is available upon request from the corresponding author (drsymons@outlook.com).
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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