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

• Sponsor: Shanghai Chest Hospital (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06152107
• Collaborator: (none)
• Enrollment: 100
• Arms: 2
• Anticipated Duration (Months): 36

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Severe Emphysema	Procedure: BTVA treatment plus optimal medical therapy (GOLD guidelines)	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Multi-center, Randomized Controlled Study to Evaluate the Efficacy and Safety of Precise Subsegmental Treatment With InterVapor for Severe Emphysema
• Anticipated Study Start Date: Nov 26, 2023
• Anticipated Primary Completion Date: Nov 26, 2025
• Anticipated Study Completion Date: Nov 26, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: subsegmental 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.	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.
Active Comparator: segmental 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.	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.

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

2. Changes in FEV1 [12 months following the second procedure]

   Changes in FEV1 from baseline at 12 months

3. 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

4. Changes in FVC [6 and 12 months following the second procedure]

   Changes in FVC from baseline at 6,12 months

5. Changes in RV [6 and 12 months following the second procedure]

   Changes in RV from baseline at 6,12 months: RV

6. Changes in TLC [6 and 12 months following the second procedure]

   Changes in TLC from baseline at 6,12 months

7. Changes in RV/TLC [6 and 12 months following the second procedure]

   Changes in RV/TLC from baseline at 6,12 months

8. Changes in DLCO [6 and 12 months following the second procedure]

   Changes in DLCO from baseline at 6,12 months

9. 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)

10. Changes in CAT [6 and 12 months following the second procedure]

    Changes in CAT from baseline at 6,12 months

11. Changes in mMRC [6 and 12 months following the second procedure]

    Changes in mMRC from baseline at 6,12 months

12. 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

13. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 88 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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;

1. 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;

2. Use of morphine derivatives within 4 weeks prior to screening;

3. Taking more than 10 mg prednisolone or equivalent daily glucocorticoids at the screening visit;

4. Recent COPD exacerbation in preceding 6 weeks;

5. 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%;

6. Presence of single large bulla (defined as > 1/3 volume of lobe) or a paraseptal distribution of emphysema in the target lobe;

7. Presence of active pathogen related infection or symptoms indicative of active infection (e.g. fever, elevated WBC, etc.);

8. 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.);

9. Highly suspicious malignant pulmonary nodules in the lungs as assessed by specialist;

10. Pregnant or breastfeeding;

11. Current enrollment in any other investigational study which has not completed requisite follow-up;

12. Any conditions assessed by investigator that make patients inappropriate for enrolment.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Shanghai Chest Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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.

• Responsible Party: Jiayuan Sun, Director, Department of Respiratory Endoscopy, Shanghai Chest Hospital, Shanghai Chest Hospital
• ClinicalTrials.gov Identifier: NCT06152107
• Other Study ID Numbers: IS23073
• First Posted: Nov 30, 2023
• Last Update Posted: Nov 30, 2023
• Last Verified: Nov 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Jiayuan Sun, Director, Department of Respiratory Endoscopy, Shanghai Chest Hospital, Shanghai Chest Hospital: Bronchoscopic Thermal Vapor Ablation (BTVA); Chronic obstructive pulmonary disease (COPD); Severe emphysema; Bronchoscopic lung volume reduction (BLVR)
• Additional relevant MeSH terms: Pulmonary Emphysema; Emphysema

Study Results

No Results Posted as of Nov 30, 2023