Ignite Creation Date:
2025-12-24 @ 10:18 PM
Ignite Modification Date:
2026-01-05 @ 5:49 PM
Study NCT ID:
NCT04161235
Status:
COMPLETED
Last Update Posted:
2023-11-15
First Post:
2019-11-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Post-Market Clinical Evaluation of the Zephyr Valve 5.5-LP EBV
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011656', 'term': 'Pulmonary Emphysema'}], 'ancestors': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}, 'targetDuration': '3 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-02-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2021-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-14', 'studyFirstSubmitDate': '2019-11-08', 'studyFirstSubmitQcDate': '2019-11-08', 'lastUpdatePostDateStruct': {'date': '2023-11-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Treated Lobar Volume Reduction (TLVR) changes from Baseline', 'timeFrame': '45 days', 'description': 'Treated Lobar Volume Reduction (TLVR) as seen via HRCT at 45-days (absolute and percent changes from baseline).'}, {'measure': 'Lobar occlusion', 'timeFrame': '45 days', 'description': 'Lobar occlusion of the treated lobe at 45-days post-procedure as visualized by HRCT.'}, {'measure': 'Post-Bronchodilator Forced Expiratory Volume in 1 second (FEV1)', 'timeFrame': '3 months', 'description': 'Post-Bronchodilator Forced Expiratory Volume in 1 second (FEV1) at 3-months (absolute and percent changes from baseline).'}, {'measure': 'Residual Volume (RV)', 'timeFrame': '3 months', 'description': 'Residual Volume at 3 months, when available (absolute and percent changes from baseline).'}, {'measure': 'Total Lung Capacity', 'timeFrame': '3 months', 'description': 'Total Lung Capacity (TLC) at 3 months, when available (absolute and percent changes from baseline).'}, {'measure': 'Inspiratory Capacity', 'timeFrame': '3 months', 'description': 'Inspiratory Capacity (IC) at 3 months, when available (absolute and percent changes from baseline).'}, {'measure': 'Residual Volume/Total Lung Capacity (RV/TLC)', 'timeFrame': '3 months', 'description': 'RV/TLC ratio at 3 months, when available (absolute and percent changes from baseline).'}, {'measure': 'Inspiratory Capacity/Total Lung Capacity (IC/TLC)', 'timeFrame': '3 months', 'description': 'IC/TLC ratio at 3 months, when available (absolute and percent changes from baseline).'}], 'primaryOutcomes': [{'measure': 'Treated Lobar Volume Reduction (TLVR) responders', 'timeFrame': '45 days', 'description': 'The percentage of patients treated with the Zephyr Valve 5.5-LP EBV who achieved a Treated Lobar Volume Reduction (TLVR) of the treated lobe (s) of ≥350ml as seen via HRCT at 45-days.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Pulmonary Emphysema']}, 'descriptionModule': {'briefSummary': 'This is a Post-Market Evaluation of the Zephyr Valve 5.5-LP EBV to assess Treated Lobar Volume Reduction (TLVR), changes in lung function and the safety profile of the Zephyr Valve treatment with the use of at least one Zephyr Valve 5.5-LP EBV.', 'detailedDescription': 'This is a multi-center, single-arm, prospective, observational study. Approximately 70 study participants undergoing Zephyr Valve treatment with the use of at least one Zephyr Valve 5.5-LP EBV will be enrolled and followed out to 3 months. Assessments will be conducted at 45 days and 3 months. The evaluation will be conducted at up to 6 sites.\n\nPatients prescribed Zephyr Valve treatment for their emphysema will be consented and will be enrolled only after: 1) determination of little to no collateral ventilation between target and ipsilateral lobes and 2) implantation of at least one Zephyr Valve 5.5-LP EBV. Baseline data will be collected retrospectively after enrollment of a patient in the Post-Market Evaluation. Performance and safety of the Zephyr Valve treatment with the use of at least one Zephyr Valve 5.5-LP will be evaluated post-treatment based on data collected until 3 months after the treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The population evaluated will comprise of patients with hyperinflation associated with severe emphysema that are considered appropriate for the procedure by their physician, confirmed to have little to no collateral ventilation and had at least one Zephyr Valve 5.5-LP EBV implanted during the procedure.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with severe emphysema prescribed treatment with Zephyr Valves\n* Zephyr Valve Treatment with the use of at least one Zephyr Valve 5.5-LP EBV\n\nExclusion Criteria:\n\n* Patients determined to have collateral ventilation between the target(s) and ipsilateral lobe(s).\n* Patients who undergo Zephyr Valve treatment, but no Zephyr Valve 5.5-LP EBV implanted.'}, 'identificationModule': {'nctId': 'NCT04161235', 'briefTitle': 'Post-Market Clinical Evaluation of the Zephyr Valve 5.5-LP EBV', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pulmonx Corporation'}, 'officialTitle': 'Post-Market Clinical Evaluation of the Zephyr Valve 5.5-LP EBV for Bronchoscopic Lung Volume Reduction (BLVR) Procedures', 'orgStudyIdInfo': {'id': '630-0025-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Treatment', 'description': 'Patients undergoing Zephyr Valve treatment with the use of at least one Zephyr Valve 5.5-LP EBV.', 'interventionNames': ['Device: The Pulmonx Zephyr Endobronchial Valve (EBV) 5.5- LP']}], 'interventions': [{'name': 'The Pulmonx Zephyr Endobronchial Valve (EBV) 5.5- LP', 'type': 'DEVICE', 'description': 'The Zephyr Valves are implantable bronchial valves intended to control airflow in order to improve lung function in patients with hyperinflation associated with severe emphysema and/or to reduce air leaks.', 'armGroupLabels': ['Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45239', 'city': 'Essen', 'country': 'Germany', 'facility': 'Ruhrlandklinik Essen - Universitätsmedizin', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'zip': '8091', 'city': 'Zurich', 'country': 'Switzerland', 'facility': 'University Hospital of Zurich', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}, {'zip': 'SW3 6NP', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Royal Brompton Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pulmonx Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}