Ignite Creation Date:
2025-12-25 @ 2:39 AM
Ignite Modification Date:
2025-12-29 @ 4:15 AM
Study NCT ID:
NCT01483534
Status:
COMPLETED
Last Update Posted:
2016-09-23
First Post:
2011-11-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Innovative Pulmonary Solutions (IPS) System for Targeted Lung Denervation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'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': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-22', 'studyFirstSubmitDate': '2011-11-29', 'studyFirstSubmitQcDate': '2011-11-30', 'lastUpdatePostDateStruct': {'date': '2016-09-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-12-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary Safety Endpoint', 'timeFrame': '365 days post procedure', 'description': 'Safety will be evaluated as freedom from documented and sustained worsening of COPD directly attributable to the investigational device or procedure.'}], 'secondaryOutcomes': [{'measure': 'Technical Feasibility', 'timeFrame': 'At time of Treatment', 'description': 'The ability to access the target treatment area and deliver RF energy to the target treatment site.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Chronic Obstructive Pulmonary Disease', 'Pulmonary', 'Intervention', 'Device', 'Denervation', 'Lung', 'Holaira, Inc.', 'Innovative Pulmonary Solutions, Inc.'], 'conditions': ['Chronic Obstructive Pulmonary Disease (COPD)']}, 'referencesModule': {'references': [{'pmid': '25739911', 'type': 'RESULT', 'citation': 'Slebos DJ, Klooster K, Koegelenberg CF, Theron J, Styen D, Valipour A, Mayse M, Bolliger CT. Targeted lung denervation for moderate to severe COPD: a pilot study. Thorax. 2015 May;70(5):411-9. doi: 10.1136/thoraxjnl-2014-206146. Epub 2015 Mar 4.'}], 'seeAlsoLinks': [{'url': 'http://thorax.bmj.com/content/early/2015/03/03/thoraxjnl-2014-206146', 'label': 'Targeted lung denervation for moderate to severe COPD: a pilot study.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety of Targeted Lung Denervation Therapy (or TLD TherapyTM) in patients suffering from COPD. Technical feasibility of the IPS SystemTM will also be evaluated through confirmation of successful application of TLD Therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* FEV1 30% to 60%\n* FEV1/FVC \\<70%\n* Prior smoker (at least 10 pack years)\n* Quit smoking for at least 6 months\n\nExclusion Criteria:\n\n* Pulmonary hypertension, peripheral edema suggesting CHF or polycythemia\n* Prior lung transplant, LVR, LVRS, median sternotomy, bullectomy or lobectomy\n* Pulmonary nodule requiring surgery\n* Presence of implantable electronic devices\n* Active respiratory infection within recent weeks\n* COPD exacerbation within recent weeks\n* Recent Myocardial infarction (MI)\n* Recent and unstable or life threatening arrhythmia\n* Malignancy treated with radiation or chemotherapy within the last 2 years\n* Presence or clinical diagnosis of other respiratory diseases other than COPD'}, 'identificationModule': {'nctId': 'NCT01483534', 'acronym': 'IPS-I', 'briefTitle': 'Innovative Pulmonary Solutions (IPS) System for Targeted Lung Denervation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Nuvaira, Inc.'}, 'officialTitle': 'Evaluation of the Innovative Pulmonary Solutions (IPS) System for Targeted Lung Denervation (TLD) Therapy in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) - A Safety Study', 'orgStudyIdInfo': {'id': 'CLP-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Targeted Lung Denervation', 'description': 'Targeted Lung Denervation', 'interventionNames': ['Device: TLD Therapy (IPS SystemTM)']}], 'interventions': [{'name': 'TLD Therapy (IPS SystemTM)', 'type': 'DEVICE', 'otherNames': ['TLD Therapy, Targeted Lung Denervation Therapy'], 'description': 'Targeted Lung Denervation Therapy will be achieved bronchoscopically. As this is a single-arm, non-randomized study, it is anticipated that all patients who provide written informed consent and meet the protocol entry criteria will undergo treatment.', 'armGroupLabels': ['Targeted Lung Denervation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9700', 'city': 'Groningen', 'country': 'Netherlands', 'facility': 'University Medical Center Groningen (UMCG)', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}, {'city': 'Panorama', 'state': 'Cape Town', 'country': 'South Africa', 'facility': 'Panorama Medi-Clinic', 'geoPoint': {'lat': -28.75383, 'lon': 31.89113}}, {'zip': '7505', 'city': 'Capetown', 'country': 'South Africa', 'facility': 'Stellenbosch University'}], 'overallOfficials': [{'name': 'Dirk-Jan Slebos, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Medical Center Groningen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nuvaira, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}