A Multi-center RCT to Evaluate Subsegmental BTVA Treatment for Severe Emphysema

Shanghai Jiao Tong University

Status: Enrolling

Conditions: Severe Emphysema

Treatments: Procedure: BTVA treatment plus optimal medical therapy (GOLD guidelines)

Study type: Interventional

Funder types: Other

Identifiers

NCT06152107

IS23073

Details and patient eligibility

About

To compare the efficacy and safety of subsegmental treatment and segmental treatment with InterVapor in patients with severe emphysema

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 88 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

subsegmental BTVA treatment plus optimal medical therapy (GOLD guidelines)

Experimental group

Description:

Patients in experimental group will be treated with the InterVapor System in at least 2 subsegments of different segments(unless the two most severe subsegments are located in the same segment) per single procedure.

Treatment:

Procedure: BTVA treatment plus optimal medical therapy (GOLD guidelines)

segmental BTVA treatment plus optimal medical therapy (GOLD guidelines)

Active Comparator group

Description:

Patients in control group will be treated with the InterVapor System in at least 1 segment per single procedure.

Treatment:

Procedure: BTVA treatment plus optimal medical therapy (GOLD guidelines)