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RECRUITING
NCT06152107
NA

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

Sponsor: Shanghai Chest Hospital

View on ClinicalTrials.gov

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

Interventions

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(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