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

Not Applicable

Not yet recruiting

• Conditions: Severe Emphysema
• Interventions: Procedure: BTVA treatment plus optimal medical therapy (GOLD guidelines)

• Registration Number: NCT06152107
• Lead Sponsor: Shanghai Chest Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-11
• Study First Submitted: 2023-11-16
• Study First Submitted QC: 2023-11-21
• Last Update Submitted: 2023-11-21
• Study Start: 2023-11-26
• Study First Posted: 2023-11-30
• Last Update Posted: 2023-11-30
• Primary Completion: 2025-11-26
• Study Completion: 2026-11-26

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
subsegmental BTVA treatment plus optimal medical therapy (GOLD guidelines)	BTVA treatment plus optimal medical therapy (GOLD guidelines)	Patients in experimental group will be treated with the InterVapor System in at least 2 subsegments of different segments per single procedure.
segmental BTVA treatment plus optimal medical therapy (GOLD guidelines)	BTVA treatment plus optimal medical therapy (GOLD guidelines)	Patients in control group will be treated with the InterVapor System in at least 1 segment per single procedure.

Primary Outcome Measures

Name	Time	Method
Improvement in FEV1	6 months following the second procedure	Improvement in FEV1 between experimental group vs control group at 6 months following the second procedure

Secondary Outcome Measures

Name	Time	Method
Changes in FEV1	12 months following the second procedure	Changes in FEV1 from baseline at 12 months
Changes in lung volumes by HRCT	6 and 12 months following the second procedure	Changes in lung volumes from baseline as assessed by HRCT at 6,12 months
A binary responder rate analysis will be performed to determine Minimal Clinically Important Difference (MCID)	6 and 12 months following the second procedure	A binary responder rate analysis will be performed to determine Minimal Clinically Important Difference (MCID) at 6,12 months: %predicted FEV1≥12% difference from baseline SGRQ-C≥8 points difference from baseline 6MWD≥30m from baseline
Changes in RV	6 and 12 months following the second procedure	Changes in RV from baseline at 6,12 months: RV
Changes in RV/TLC	6 and 12 months following the second procedure	Changes in RV/TLC from baseline at 6,12 months
Changes in 6MWD	6 and 12 months following the second procedure	Changes in 6MWD from baseline at 6,12 months (patients with lower limb disability or motor dysfunction will be exempted from the test)
Incidence of Adverse Events	during or within 12 months after the operation	Adverse events related to the procedure during or within 12 months after the operation
Changes in FVC	6 and 12 months following the second procedure	Changes in FVC from baseline at 6,12 months
Changes in TLC	6 and 12 months following the second procedure	Changes in TLC from baseline at 6,12 months
Changes in Quality-of-Life score	6 and 12 months following the second procedure	Changes in Quality-of-Life score as assessed by the SGRQ-C questionnaire from baseline at 6,12 months
Changes in DLCO	6 and 12 months following the second procedure	Changes in DLCO from baseline at 6,12 months
Changes in CAT	6 and 12 months following the second procedure	Changes in CAT from baseline at 6,12 months
Changes in mMRC	6 and 12 months following the second procedure	Changes in mMRC from baseline at 6,12 months