NCT06152107RecruitingNot Applicable
A Multi-center, Randomized Controlled Study to Evaluate the Efficacy and Safety of Precise Subsegmental Treatment With InterVapor for Severe Emphysema
Shanghai Chest Hospital18 sites in 1 country100 target enrollmentStarted: January 1, 2024Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Shanghai Chest Hospital
- Enrollment
- 100
- Locations
- 18
- Primary Endpoint
- Improvement in FEV1
Study Overview
Brief Summary
To compare the efficacy and safety of subsegmental treatment and segmental treatment with InterVapor in patients with severe emphysema
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age≥18 years old;
- •Patients with severe emphysema and with at least two treatable subsegments and 1 treatable segment in the ipsilateral lung assessed by QCT;
- •Non-smoking for 2 months prior to study enrollment, and remain abstinent from smoking for the duration of the study;
- •15%predicted≤FEV1≤50%predicted, TLC≥100% predicted, RV≥150% predicted (and RV/ TLC≥55%);
- •6MWD >140 meters (patients with lower limb disability or motor dysfunction will be exempted from the test)
- •mMRC score≥2;
- •Arterial blood gas levels of: PaCO2≤55 mmHg; PaO2>50 mmHg on room air;
- •Mentally and physically able to cooperate with the study procedures and to provide informed consent prior to study enrollment.
Exclusion Criteria
- •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;
- •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;
- •Use of morphine derivatives within 4 weeks prior to screening;
- •Taking more than 10 mg prednisolone or equivalent daily glucocorticoids at the screening visit;
- •Recent COPD exacerbation in preceding 6 weeks;
- •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%;
- •Presence of single large bulla (defined as > 1/3 volume of lobe) or a paraseptal distribution of emphysema in the target lobe;
- •Presence of active pathogen related infection or symptoms indicative of active infection (e.g. fever, elevated WBC, etc.);
- •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.);
- •Highly suspicious malignant pulmonary nodules in the lungs as assessed by specialist;
- •Pregnant or breastfeeding;
- •Current enrollment in any other investigational study which has not completed requisite follow-up;
- •Any conditions assessed by investigator that make patients inappropriate for enrolment.
Arms & Interventions
subsegmental BTVA treatment plus optimal medical therapy (GOLD guidelines)
Experimental
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.
Intervention: BTVA treatment plus optimal medical therapy (GOLD guidelines) (Procedure)
segmental BTVA treatment plus optimal medical therapy (GOLD guidelines)
Active Comparator
Patients in control group will be treated with the InterVapor System in at least 1 segment per single procedure.
Intervention: BTVA treatment plus optimal medical therapy (GOLD guidelines) (Procedure)
Outcomes
Primary Outcomes
Improvement in FEV1
Time Frame: 6 months following the second procedure
Improvement in FEV1 between experimental group vs control group at 6 months following the second procedure
Secondary Outcomes
- A binary responder rate analysis will be performed to determine Minimal Clinically Important Difference (MCID)(6 and 12 months following the second procedure)
- Changes in lung volumes by HRCT(6 and 12 months following the second procedure)
- Changes in FEV1(12 months following the second procedure)
- Changes in Quality-of-Life score(6 and 12 months following the second procedure)
- Changes in FVC(6 and 12 months following the second procedure)
- Changes in RV(6 and 12 months following the second procedure)
- Changes in TLC(6 and 12 months following the second procedure)
- Changes in RV/TLC(6 and 12 months following the second procedure)
- Changes in DLCO(6 and 12 months following the second procedure)
- Changes in 6MWD(6 and 12 months following the second procedure)
- Changes in CAT(6 and 12 months following the second procedure)
- Changes in mMRC(6 and 12 months following the second procedure)
- A binary responder rate analysis will be performed to determine Minimal Clinically Important Difference (MCID)(6 and 12 months following the second procedure)
- Incidence of Adverse Events(during or within 12 months after the operation)
Investigators
Jiayuan Sun
Director, Department of Respiratory Endoscopy, Shanghai Chest Hospital
Shanghai Chest Hospital
Study Sites (18)
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