Ignite Creation Date:
2025-12-26 @ 10:58 AM
Ignite Modification Date:
2026-02-27 @ 12:49 AM
Study NCT ID:
NCT03318406
Status:
RECRUITING
Last Update Posted:
2025-01-28
First Post:
2017-10-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Post-Market BTVA Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Czechia', 'Ireland', 'Netherlands', 'United Kingdom']}, 'conditionBrowseModule': {'meshes': [{'id': 'D004646', 'term': 'Emphysema'}, {'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-03-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2030-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-25', 'studyFirstSubmitDate': '2017-10-13', 'studyFirstSubmitQcDate': '2017-10-18', 'lastUpdatePostDateStruct': {'date': '2025-01-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Quality of Life', 'timeFrame': 'Baseline to 24 months', 'description': 'Change in Quality of Life score as assessed by the SGRQ-C questionnaire'}], 'secondaryOutcomes': [{'measure': 'Serious Adverse Events', 'timeFrame': '6 and 12 months', 'description': 'procedure and device related serious adverse events, major medical complications'}, {'measure': 'Change in FEV1', 'timeFrame': 'Baseline to 12 months', 'description': 'Change in Forced Expired Volume in 1 second'}, {'measure': 'Change in FVC', 'timeFrame': 'Baseline to 12 months', 'description': 'Change in Forced Vital Capacity'}, {'measure': 'Change in TLC', 'timeFrame': 'Baseline to 12 months', 'description': 'Change in Total Lung Capacity'}, {'measure': 'Change in RV', 'timeFrame': 'Baseline to 12 months', 'description': 'Change in Residual Volume'}, {'measure': 'Change in DLCO', 'timeFrame': 'Baseline to 12 months', 'description': 'Change in Diffusing capacity of the lung for carbon monoxide'}, {'measure': 'Exercise Tolerance', 'timeFrame': 'Baseline to 12 months', 'description': 'Change in six minute walk distance'}, {'measure': 'Lung volume reduction', 'timeFrame': 'Baseline to 6 months', 'description': 'change in lung volume assessed by CT'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['registry', 'vapor ablation', 'InterVapor', 'BTVA'], 'conditions': ['Emphysema or COPD']}, 'descriptionModule': {'briefSummary': "Bronchoscopic thermal vapor ablation using Uptake Medical Technology Inc.'s InterVapor System is indicated for treatment of patients with heterogeneous upper lobe emphysema. This study is a retrospective and prospective, observational, multi-center, post-market registry of patients prescribed InterVapor. The primary objective of the Registry is to describe the long-term impact of InterVapor treatment on patient quality of life (QOL) in a real-world setting. After InterVapor treatment, patients will be followed for 5 years as per the standard of care and safety and efficacy data (quality of life, pulmonary function, exercise capacity) collected as part of the registry.", 'detailedDescription': 'The BTVA Registry will enroll up to 300 patients with upper lobe predominant emphysema that are being treated with BTVA at sites located in the EU and other select geographies. Patients will be followed as per standard of care and the registry will collect follow-up data for five years following treatment. The follow up data collected will include pulmonary function measurements (spirometry, body plethysmography, and diffusing capacity for carbon monoxide), exercise capacity (six minute walk test), imaging findings (chest x-ray and CT), and a quality of life questionnaire (SGRQ-C). All serious and non-serious adverse events will also be collected for the duration of the study in order to assess safety. Serious adverse events will be adjudicated by an independent medical monitor in order to establish relatedness to the InterVapor device and procedure.\n\nDescriptive statistics will be used to summarize all safety and effectiveness data. There is no predefined hypothesis regarding the magnitude of effectiveness of InterVapor or the incidence of specific safety outcomes.\n\nMonitoring of the registry study will be undertaken as a continuous process to ensure that high-quality data are obtained and to ensure compliance with registry procedures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with upper lobe predominant emphysema being evaluated for possible InterVapor treatment will be considered for enrollment in the Registry', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients will have heterogeneous emphysema, as evidenced by high-resolution computed tomography (HRCT) demonstrating a heterogeneity index \\> or equal to 1.2 in at least one segment to be treated\n2. Patients must be \\> or equal to 18 years of age\n3. Patients are required to provide informed consent prior to inclusion in the Registry\n\nExclusion Criteria:\n\n1. FEV1 \\< 20% predicted\n2. DLCO \\< 20% predicted\n3. Inability to walk \\> 140 meters in 6 minutes (6MWD) following optimized medical management\n4. Unstable COPD (any of the following):\n\n 1. \\> 3 COPD related hospitalizations requiring antibiotics in past 12 months\n 2. COPD related hospitalization in past 3 months\n 3. daily use of systemic steroids, i.e. \\> 5 mg prednisolone\n5. Concomitant illnesses or medications that would pose a significant increased risk for complications following treatment with InterVapor. Examples of particular relevance include: immune system disorders, immunosuppressant medications of clinical relevance, bleeding disorders and unstable cardiovascular conditions, history of asthma or alpha-1 antitrypsin deficiency\n6. Newly prescribed morphine derivatives within the last 4 weeks\n7. Pregnant or breastfeeding\n8. Highly diseased lower lobes (tissue to air ratio of \\<11%)\n9. Bacterial infection or symptoms indicative of active infection (i.e., fever, elevated white blood cell count)\n10. Presence of single large bulla (defined as \\> 1/3 volume of lobe) or a paraseptal distribution of emphysema in the treated lobe\n11. Recent respiratory infections or COPD exacerbation in preceding 6 weeks -'}, 'identificationModule': {'nctId': 'NCT03318406', 'briefTitle': 'Post-Market BTVA Registry', 'organization': {'class': 'INDUSTRY', 'fullName': 'Uptake Medical Technology, Inc.'}, 'officialTitle': 'Post-Market Registry for Patients With Emphysema Treated With BTVA', 'orgStudyIdInfo': {'id': 'CSP-2410'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'BTVA treated patients', 'description': 'Patients with heterogeneous upper lobe emphysema undergoing Bronchoscopic Thermal Vapor Ablation treatment', 'interventionNames': ['Device: Bronchoscopic Thermal Vapor Ablation']}], 'interventions': [{'name': 'Bronchoscopic Thermal Vapor Ablation', 'type': 'DEVICE', 'otherNames': ['BTVA', 'InterVapor'], 'description': 'Bronchoscopic vapor delivery to airway segment(s) targeted for treatment', 'armGroupLabels': ['BTVA treated patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1210', 'city': 'Vienna', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Welz Kelly', 'role': 'CONTACT', 'email': 'kelly.welz@extern.gesundheitsverbund.at'}, {'name': 'Arschang Valipour, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Krankenhaus Nord - Klinik Floridsdorf', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '96049', 'city': 'Bamberg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Beate Klaus', 'role': 'CONTACT'}, {'name': 'Wolfgang Hohenforst-Schmidt, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Sozialstiftung Bamberg, Klinikum am Bruderwald', 'geoPoint': {'lat': 49.89873, 'lon': 10.90067}}, {'zip': '13359', 'city': 'Berlin', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Jeanette Natschke', 'role': 'CONTACT', 'email': 'j.natschke@drk-kliniken-berlin.de'}, {'name': 'Bernd Schmidt, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'DRK Kliniken Berlin / Mitte', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '14089', 'city': 'Berlin', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Claudia Leichnitz', 'role': 'CONTACT', 'email': 'Claudia.leichnitz@havelhohe.de'}, {'name': 'Christian Grah, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'FORSCHUNGSINSTITUT Havelhöhe gGmbH', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '45147', 'city': 'Essen', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Birte Schwarz', 'role': 'CONTACT', 'email': 'birte.schwarz@uk-essen.de'}, {'name': 'Kaid Darwiche, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ruhrlandklinik - Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'zip': '82131', 'city': 'Gauting', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Rosalie Untsch', 'role': 'CONTACT', 'email': 'ro.untsch@asklepios.com'}, {'name': 'Wolfgang Gesierich, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Asklepios Fachkliniken München-Gauting', 'geoPoint': {'lat': 48.06919, 'lon': 11.37703}}, {'zip': '06120', 'city': 'Halle', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Susanne Behl', 'role': 'CONTACT', 'email': 'susanne.behl@uk-halle.de'}, {'name': 'Stephan Eisenmann, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Martin-Luther-Universität Halle-Wittenberg (Saale)', 'geoPoint': {'lat': 51.48158, 'lon': 11.97947}}, {'zip': '69126', 'city': 'Heidelberg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Michaela Korthoeber', 'role': 'CONTACT', 'email': 'michaela.korthoeber@med.uni-heidelberg.de'}, {'name': 'Felix Herth, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Ralf Eberhardt, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Thoraxklinik Heidelberg', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}, {'zip': '58675', 'city': 'Hemer', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Anja Schmidt', 'role': 'CONTACT', 'email': 'Anja.Schmidt@lkhemer.de'}, {'name': 'Franz Stanzel, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Lungenklinik Hemer', 'geoPoint': {'lat': 51.38707, 'lon': 7.77019}}, {'zip': '34376', 'city': 'Immenhausen', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Katrin Schwedler', 'role': 'CONTACT', 'email': 'k.schwedler@lungenfachklinik-immenhausen.de'}, {'name': 'Peter Hammerl, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Lungenfachklinik Immenhausen', 'geoPoint': {'lat': 51.42763, 'lon': 9.48017}}, {'zip': '81479', 'city': 'München', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Andreas Fertl, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Krankenhaus Martha-Maria München', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'zip': '90419', 'city': 'Nuremberg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Tanja Goetz', 'role': 'CONTACT', 'email': 'tanja.goetz@klinikum-nuernberg.de'}, {'name': 'Joachim Ficker, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Klinikum Nürnberg Nord', 'geoPoint': {'lat': 49.45421, 'lon': 11.07752}}, {'zip': '70372', 'city': 'Stuttgart', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Ute Höß', 'role': 'CONTACT', 'email': 'ute.hoess@sana.de'}, {'name': 'Martin Hetzel, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Krankenhaus vom Roten Kreuz Bad Cannstatt GmbH', 'geoPoint': {'lat': 48.78232, 'lon': 9.17702}}, {'zip': '70376', 'city': 'Stuttgart', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Nina Lutz', 'role': 'CONTACT', 'email': 'nina.lutz@rbk.de'}, {'name': 'Claus Neurohr, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Klinik Schillerhöhe', 'geoPoint': {'lat': 48.78232, 'lon': 9.17702}}, {'zip': '5001', 'city': 'Aarau', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Sarosh Irani, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Kantonsspital Aarau AG', 'geoPoint': {'lat': 47.39254, 'lon': 8.04422}}, {'zip': '4031', 'city': 'Basel', 'status': 'NOT_YET_RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Sandra Kunze', 'role': 'CONTACT', 'email': 'Sandra.Kunze@usb.ch'}, {'name': 'Michael Tamm, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University Hospital Basel', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}, {'zip': '3012', 'city': 'Bern', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Tina Lauper', 'role': 'CONTACT', 'email': 'tina.lauper@pneumo-lindenhof.ch'}, {'name': 'Kaspar Remund, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Lungen-und Schlafzentrum am Lindenhofspital AG, Bern', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}, {'zip': '9000', 'city': 'Sankt Gallen', 'status': 'WITHDRAWN', 'country': 'Switzerland', 'facility': 'Kantonsspital St.Gallen', 'geoPoint': {'lat': 47.42391, 'lon': 9.37477}}, {'zip': '8032', 'city': 'Zurich', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Karl Klingler, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'LungenZentrum Hirslanden', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}, {'zip': '8091', 'city': 'Zurich', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Christa Bodmer', 'role': 'CONTACT', 'email': 'Christa.Bodmer@usz.ch'}, {'name': 'Daniel Franzen, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Universitäts Spital Zürich', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'centralContacts': [{'name': 'Jennifer Idris', 'role': 'CONTACT', 'email': 'jidris@broncus.com', 'phone': '+1-408-391-0098'}], 'overallOfficials': [{'name': 'Felix Herth, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Thoraxklinik University of Heidelberg'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Uptake Medical Technology, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}