NCT06152107 A Multi-center RCT to Evaluate Subsegmental BTVA Treatment for Severe Emphysema
| NCT ID | NCT06152107 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Shanghai Chest Hospital |
| Condition | Severe Emphysema |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-01-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2024-01-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
To compare the efficacy and safety of subsegmental treatment and segmental treatment with InterVapor in patients with severe emphysema
Eligibility Criteria
Inclusion Criteria: 1. Age≥18 years old; 2. Patients with severe emphysema and with at least two treatable subsegments and 1 treatable segment in the ipsilateral lung assessed by QCT; 3. Non-smoking for 2 months prior to study enrollment, and remain abstinent from smoking for the duration of the study; 4. 15%predicted≤FEV1≤50%predicted, TLC≥100% predicted, RV≥150% predicted (and RV/ TLC≥55%); 5. 6MWD \>140 meters (patients with lower limb disability or motor dysfunction will be exempted from the test) 6. mMRC score≥2; 7. Arterial blood gas levels of: PaCO2≤55 mmHg; PaO2\>50 mmHg on room air; 8. Mentally and physically able to cooperate with the study procedures and to provide informed consent prior to study enrollment. Exclusion Criteria: 1. Contraindications to bronchoscopy, such as: Prior myocardial infarction within 1 month, unstable myocardial ischaemia, ejection fraction (EF) ≤ 40%; Active haemoptysis; Coagulation disorders; Malignant cardiac arrhythmia, severe pulmonary hypertension, extreme systemic failure, etc; 2. Concomitant illnesses or medications that would pose a significant increased risk for complications following treatment with InterVapor. Examples of particular relevance include: immune system disorders, immunosuppressant medications of clinical relevance, bleeding disorders and unstable cardiovascular conditions, history of asthma or alpha-1 antitrypsin deficiency; 3. Use of morphine derivatives within 4 weeks prior to screening; 4. Taking more than 10 mg prednisolone or equivalent daily glucocorticoids at the screening visit; 5. Recent COPD exacerbation in preceding 6 weeks; 6. Severe emphysema in both the upper and lower lobes of the contralateral lungs, defined as %LAA-950 assessed by HRCT as a percentage of whole lung lobe volume \> 40%; 7. Presence of single large bulla (defined as \> 1/3 volume of lobe) or a paraseptal distribution of emphysema in the target lobe; 8. Presence of active pathogen related infection or symptoms indicative of active infection (e.g. fever, elevated WBC, etc.); 9. History of heart and/or lung transplant, lung volume reduction surgery (LVRS), median sternotomy, bullectomy, thoracic surgery with removal of lung tissue and endobronchial lung volume reduction (via valves, coils, stents, etc.); 10. Highly suspicious malignant pulmonary nodules in the lungs as assessed by specialist; 11. Pregnant or breastfeeding; 12. Current enrollment in any other investigational study which has not completed requisite follow-up; 13. Any conditions assessed by investigator that make patients inappropriate for enrolment.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06152107 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Severe Emphysema. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06152107 currently recruiting?
Yes, NCT06152107 is actively recruiting participants. Contact the research team at jysun1976@163.com for enrollment information.
Where is the NCT06152107 trial being conducted?
This trial is being conducted at Zhengzhou, China, Beijing, China, Chengdu, China, Linyi, China and 5 additional locations.
Who is sponsoring the NCT06152107 clinical trial?
NCT06152107 is sponsored by Shanghai Chest Hospital. The trial plans to enroll 100 participants.