Clinical trial NCT06152107: A Multi-center RCT to Evaluate Subsegmental BTVA Treatment for Severe Emphysema
Official title: A Multi-center, Randomized Controlled Study to Evaluate the Efficacy and Safety of Precise Subsegmental Treatment With InterVapor for Severe Emphysema
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Severe Emphysema
Keywords: Bronchoscopic Thermal Vapor Ablation (BTVA)
Chronic obstructive pulmonary disease (COPD)
Severe emphysema
Bronchoscopic lung volume reduction (BLVR)
Lead sponsor: Shanghai Chest Hospital
Sponsor class: OTHER
First posted: 2023-11-30
Enrollment: 100
Sex: MALE
Minimum age (years): 18
Maximum age (years): 88
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Primary outcomes:
measure: Improvement in FEV1
timeFrame: 6 months following the second procedure
Secondary outcomes:
measure: Changes in lung volumes by HRCT
timeFrame: 6 and 12 months following the second procedure
measure: Changes in FEV1
timeFrame: 12 months following the second procedure
measure: Changes in Quality-of-Life score
timeFrame: 6 and 12 months following the second procedure
measure: Changes in FVC
timeFrame: 6 and 12 months following the second procedure
measure: Changes in RV
timeFrame: 6 and 12 months following the second procedure
measure: Changes in TLC
timeFrame: 6 and 12 months following the second procedure
measure: Changes in RV/TLC
timeFrame: 6 and 12 months following the second procedure
measure: Changes in DLCO
timeFrame: 6 and 12 months following the second procedure
measure: Changes in 6MWD
timeFrame: 6 and 12 months following the second procedure
measure: Changes in CAT
timeFrame: 6 and 12 months following the second procedure
measure: Changes in mMRC
timeFrame: 6 and 12 months following the second procedure
measure: A binary responder rate analysis will be performed to determine Minimal Clinically Important Difference (MCID)
timeFrame: 6 and 12 months following the second procedure
measure: Incidence of Adverse Events
timeFrame: during or within 12 months after the operation
Other outcomes:
Locations:
Study officials:
References:
citation: Gompelmann D, Shah PL, Valipour A, Herth FJF. Bronchoscopic Thermal Vapor Ablation: Best Practice Recommendations from an Expert Panel on Endoscopic Lung Volume Reduction. Respiration. 2018;95(6):392-400. doi: 10.1159/000489815. Epub 2018 Jun 12.
citation: Shah PL, Herth FJ, van Geffen WH, Deslee G, Slebos DJ. Lung volume reduction for emphysema. Lancet Respir Med. 2017 Feb;5(2):147-156. doi: 10.1016/S2213-2600(16)30221-1. Epub 2016 Sep 29.
citation: Bandyopadhyay S, Henne E, Gupta A, Barry R, Snell G, Strange C, Herth FJ. Segmental approach to lung volume reduction therapy for emphysema patients. Respiration. 2015;89(1):76-81. doi: 10.1159/000369036. Epub 2014 Dec 6.