Health Condition 1: J439- Emphysema, unspecified
Conditions
Interventions
Intervention1: InterVapor Generator: Treatment will be administered by the treating physician according to the Instructions for Use (IFU). Segment(s) in either the right or left upper lobe will be tar
Sponsors
Uptake Medical BV
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patients who have heterogeneous emphysema, as evidenced by high-resolution CT demonstrating a heterogeneity Index greater than 1.2 in at least one segment to be treated; 2.Patients must be greater than or equal to 18 years of age; 3.Patients must have the capacity to provide informed consent and are required to provide informed consent prior to inclusion in this registry.
Exclusion criteria
Exclusion criteria: 1.FEV1 is less than 20% predicted; 2.DLCO is less than 20% predicted; 3.Inability to walk is more than 140 meters in 6 minutes (6MWD) following optimized medical management; 4.Unstable COPD (any of the following): a.more than 3 COPD related hospitalizations requiring antibiotics in past 12 months b.COPD related hospitalization in past 3 months c.daily use of systemic steroids, i.e.more than 5 mg prednisolone; 5.Unable to discontinue anti-coagulants or platelet inhibitors (non-ASA and ASA is more than 100mg daily) pre-procedure and for at least 6 weeks post-procedure; 6.Concomitant illnesses or medications that would pose a significant increased risk for complications following treatment with InterVapor Newly prescribed morphine derivatives within the last 4 weeks 7.Newly prescribed morphine derivatives within the last 4 weeks; 8.Pregnant or breastfeeding; 9.Highly diseased lower lobes (tissue to air ratio is less than 11%); 10.Bacterial infection or symptoms indicative of active infection (i.e., fever, elevated white blood cell count); 11.Presence of single large bulla (defined as more than 1/3 volume of lobe) or a paraseptal distribution of emphysema in the treated lobe; 12.Recent respiratory infections or COPD exacerbation in preceding 6 weeks;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the change in St. George’s Respiratory Questionnaire for COPD (SGRQ-C) score at six (6) months post-treatment relative to pre-treatment baselineTimepoint: 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| change in exercise tolerance at twelve (12) months assessed by 6MWT relative to pre-treatment baselineTimepoint: twelve (12) months from baseline;change in forced expired volume in 1 second (FEV1), forced vital capacity (FVC), residual volume (RV), total lung capacity (TLC), and DLCO at twelve (12) months assessed by pulmonary function tests relative to pre-treatment baselineTimepoint: twelve (12) months from baseline;lung volume reduction at six (6) months assessed by high resolution CTTimepoint: six (6) months from baseline;six (6) and twelve (12) month serious adverse events (further categorized into procedure-related and device-related SAEs, and major medical complications) Timepoint: six (6) and twelve (12) months from baseline;the change in SGRQ-C at twelve (12) months post-treatment relative to pre-treatment baselineTimepoint: twelve (12) months from baseline | — |
Countries
India
Contacts
Public ContactDr Venkata Nagarjuna Maturu
Yashoda Hospital
Outcome results
None listed