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

Severe Emphysema Clinical Trial

— BTVA  

Official title:

A Multi-center, Randomized Controlled Study to Evaluate the Efficacy and Safety of Precise Subsegmental Treatment With InterVapor for Severe Emphysema

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06152107
• Other study ID #: IS23073
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 26, 2023
• Est. completion date: November 26, 2026

Study information

• Verified date: November 2023
• Source: Shanghai Chest Hospital
• Contact: Jiayuan Sun, MD., PhD.
• Phone: 86-021-22200000
• Email: jysun1976[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: November 26, 2026
• Est. primary completion date: November 26, 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 88 Years

Eligibility

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.

Related Conditions & MeSH terms

• Emphysema
• Pulmonary Emphysema
• Severe Emphysema

Intervention

Procedure:
• 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. Patients in control group will be treated with the InterVapor System in at least 1 segment. A sequential procedure allows for at least 6 weeks and no longer than 6 months after the first procedure. Patients in both groups will be treated in the ipsilateral lobe in a single procedure with the air+tissue volume of at least=500 ml and=1,700 ml in per procedure. All patients will continue to receive optimal medical therapy (GOLD guidelines) for the duration of the study. Follow-up visits will be scheduled at 1, 3, 6 and 12 months following the second procedure with examination of pulmonary function tests, HRCT, 6-minute walk test, SGRQ-C, mMRC, CAT questionnaires. All adverse events during the study will be recorded.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Chest Hospital

References & Publications (3)

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. — View 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. — View 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. Erratum In: Lancet Respir Med. 2016 Nov;4(11):e55. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in FEV1	Improvement in FEV1 between experimental group vs control group at 6 months following the second procedure	6 months following the second procedure
Secondary	Changes in lung volumes by HRCT	Changes in lung volumes from baseline as assessed by HRCT at 6,12 months	6 and 12 months following the second procedure
Secondary	Changes in FEV1	Changes in FEV1 from baseline at 12 months	12 months following the second procedure
Secondary	Changes in Quality-of-Life score	Changes in Quality-of-Life score as assessed by the SGRQ-C questionnaire from baseline at 6,12 months	6 and 12 months following the second procedure
Secondary	Changes in FVC	Changes in FVC from baseline at 6,12 months	6 and 12 months following the second procedure
Secondary	Changes in RV	Changes in RV from baseline at 6,12 months: RV	6 and 12 months following the second procedure
Secondary	Changes in TLC	Changes in TLC from baseline at 6,12 months	6 and 12 months following the second procedure
Secondary	Changes in RV/TLC	Changes in RV/TLC from baseline at 6,12 months	6 and 12 months following the second procedure
Secondary	Changes in DLCO	Changes in DLCO from baseline at 6,12 months	6 and 12 months following the second procedure
Secondary	Changes in 6MWD	Changes in 6MWD from baseline at 6,12 months (patients with lower limb disability or motor dysfunction will be exempted from the test)	6 and 12 months following the second procedure
Secondary	Changes in CAT	Changes in CAT from baseline at 6,12 months	6 and 12 months following the second procedure
Secondary	Changes in mMRC	Changes in mMRC from baseline at 6,12 months	6 and 12 months following the second procedure
Secondary	A binary responder rate analysis will be performed to determine Minimal Clinically Important Difference (MCID)	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	6 and 12 months following the second procedure
Secondary	Incidence of Adverse Events	Adverse events related to the procedure during or within 12 months after the operation	during or within 12 months after the operation