To compare the efficacy and safety of subsegmental treatment and segmental treatment with InterVapor in patients with severe emphysema
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
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.
Henan Provincial People's Hospital
Zhengzhou, Henan, China
RECRUITINGEmergency General Hospital
Beijing, China
NOT_YET_RECRUITINGWest China Hospital of Sichuan University
Chengdu, China
Improvement in FEV1
Improvement in FEV1 between experimental group vs control group at 6 months following the second procedure
Time frame: 6 months following the second procedure
Changes in lung volumes by HRCT
Changes in lung volumes from baseline as assessed by HRCT at 6,12 months
Time frame: 6 and 12 months following the second procedure
Changes in FEV1
Changes in FEV1 from baseline at 12 months
Time frame: 12 months following the second procedure
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
Time frame: 6 and 12 months following the second procedure
Changes in FVC
Changes in FVC from baseline at 6,12 months
Time frame: 6 and 12 months following the second procedure
Changes in RV
Changes in RV from baseline at 6,12 months: RV
Time frame: 6 and 12 months following the second procedure
Changes in TLC
Changes in TLC from baseline at 6,12 months
Time frame: 6 and 12 months following the second procedure
Changes in RV/TLC
Changes in RV/TLC from baseline at 6,12 months
Time frame: 6 and 12 months following the second procedure
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Linyi People's Hospital
Linyi, China
NOT_YET_RECRUITINGJiangxi Provincial People's Hospital
Nanchang, China
NOT_YET_RECRUITINGShanghai Chest Hospital
Shanghai, China
RECRUITINGShanghai Sixth People's Hospital
Shanghai, China
NOT_YET_RECRUITINGHebei Provincial People's Hospital
Shijiazhuang, China
NOT_YET_RECRUITINGSir Run Run Shaw Hospital affiliated to Zhejiang University School of Medicine
Zhejiang, China
RECRUITINGChanges in DLCO
Changes in DLCO from baseline at 6,12 months
Time frame: 6 and 12 months following the second procedure
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)
Time frame: 6 and 12 months following the second procedure
Changes in CAT
Changes in CAT from baseline at 6,12 months
Time frame: 6 and 12 months following the second procedure
Changes in mMRC
Changes in mMRC from baseline at 6,12 months
Time frame: 6 and 12 months following the second procedure
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≥26m from baseline
Time frame: 6 and 12 months following the second procedure
Incidence of Adverse Events
Adverse events related to the procedure during or within 12 months after the operation
Time frame: during or within 12 months after the operation