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

NARecruitingINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

January 1, 2024

Primary Completion Date

December 31, 2026

Study Completion Date

December 31, 2027

Conditions
Severe Emphysema
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."

Trial Locations (9)

100028

NOT_YET_RECRUITING

Emergency General Hospital, Beijing

200030

RECRUITING

Shanghai Chest Hospital, Shanghai

310009

RECRUITING

Sir Run Run Shaw Hospital affiliated to Zhejiang University School of Medicine, Zhejiang

450003

RECRUITING

Henan Provincial People's Hospital, Zhengzhou

610041

NOT_YET_RECRUITING

West China Hospital of Sichuan University, Chengdu

Unknown

NOT_YET_RECRUITING

Linyi People's Hospital, Linyi

NOT_YET_RECRUITING

Jiangxi Provincial People's Hospital, Nanchang

NOT_YET_RECRUITING

Shanghai Sixth People's Hospital, Shanghai

NOT_YET_RECRUITING

Hebei Provincial People's Hospital, Shijiazhuang

All Listed Sponsors
lead

Shanghai Chest Hospital

OTHER