Actively Recruiting
A Multi-center RCT to Evaluate Subsegmental BTVA Treatment for Severe Emphysema
Led by Shanghai Chest Hospital · Updated on 2025-09-08
100
Participants Needed
9
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To compare the efficacy and safety of subsegmental treatment and segmental treatment with InterVapor in patients with severe emphysema
CONDITIONS
Official Title
A Multi-center RCT to Evaluate Subsegmental BTVA Treatment for Severe Emphysema
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Severe emphysema with at least two treatable subsegments and one treatable segment in the same lung
- Non-smoker for at least 2 months before joining and must remain smoke-free during the study
- FEV1 between 15% and 50% of predicted, TLC 100% or less of predicted, RV 150% or more of predicted, and RV/TLC ratio 55% or less
- Able to walk more than 140 meters in 6 minutes unless limited by lower limb disability
- Modified Medical Research Council (mMRC) score of 2 or higher
- Arterial blood gas levels with PaCO2 55 mmHg or less and PaO2 over 50 mmHg on room air
- Mentally and physically able to cooperate and give informed consent
You will not qualify if you...
- Contraindications to bronchoscopy such as recent heart attack, unstable heart conditions, low heart ejection fraction, active bleeding, clotting disorders, severe pulmonary hypertension, or extreme systemic failure
- Conditions or medications that increase risk of complications, including immune disorders, immunosuppressants, bleeding disorders, unstable cardiovascular conditions, history of asthma or alpha-1 antitrypsin deficiency
- Use of morphine derivatives within 4 weeks before screening
- Taking more than 10 mg prednisolone or equivalent daily at screening
- COPD exacerbation within 6 weeks before screening
- Severe emphysema in both upper and lower lobes of the opposite lung (over 40% affected)
- Presence of a large bulla or paraseptal emphysema in the target lobe
- Active infection or symptoms indicating infection such as fever or high white blood cell count
- History of heart or lung transplant, lung volume reduction surgery, bullectomy, or thoracic surgery removing lung tissue
- Suspicion of malignant lung nodules
- Pregnant or breastfeeding
- Currently enrolled in another investigational study without completed follow-up
- Any condition deemed by the investigator to make the patient unsuitable for the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 9 locations
1
Henan Provincial People's Hospital
Zhengzhou, Henan, China, 450003
Actively Recruiting
2
Emergency General Hospital
Beijing, China, 100028
Not Yet Recruiting
3
West China Hospital of Sichuan University
Chengdu, China, 610041
Not Yet Recruiting
4
Linyi People's Hospital
Linyi, China
Not Yet Recruiting
5
Jiangxi Provincial People's Hospital
Nanchang, China
Not Yet Recruiting
6
Shanghai Chest Hospital
Shanghai, China, 200030
Actively Recruiting
7
Shanghai Sixth People's Hospital
Shanghai, China
Not Yet Recruiting
8
Hebei Provincial People's Hospital
Shijiazhuang, China
Not Yet Recruiting
9
Sir Run Run Shaw Hospital affiliated to Zhejiang University School of Medicine
Zhejiang, China, 310009
Actively Recruiting
Research Team
J
Jiayuan Sun, MD., PhD.
CONTACT
H
Huan Hou, MD., PhD.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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