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A Multi-center RCT to Evaluate Subsegmental BTVA Treatment for Severe Emphysema
Sponsor: Shanghai Chest Hospital
Summary
To compare the efficacy and safety of subsegmental treatment and segmental treatment with InterVapor in patients with 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2024-01-01
Completion Date
2027-12-31
Last Updated
2025-09-08
Healthy Volunteers
No
Conditions
Interventions
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(unless the two most severe subsegments are located in the same segment). 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 receive ipsilateral hemithorax treatment per procedure, with a treatment volume (air + tissue) of ≤1700 mL per procedure and ≥1000 mL cumulatively across two procedures. 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 (9)
Henan Provincial People's Hospital
Zhengzhou, Henan, China
Emergency General Hospital
Beijing, China
West China Hospital of Sichuan University
Chengdu, China
Linyi People's Hospital
Linyi, China
Jiangxi Provincial People's Hospital
Nanchang, China
Shanghai Chest Hospital
Shanghai, China
Shanghai Sixth People's Hospital
Shanghai, China
Hebei Provincial People's Hospital
Shijiazhuang, China
Sir Run Run Shaw Hospital affiliated to Zhejiang University School of Medicine
Zhejiang, China