Ignite Creation Date:
2025-12-24 @ 3:04 PM
Ignite Modification Date:
2026-02-02 @ 9:32 AM
Study NCT ID:
NCT00650559
Status:
TERMINATED
Last Update Posted:
2008-04-01
First Post:
2008-03-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Thorax Enlarging Surgery: a Novel Surgical Approach to Emphysema
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D004646', 'term': 'Emphysema'}], '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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4}}, 'statusModule': {'whyStopped': 'post-surgical complications in the last 2 patients', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2004-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-03', 'completionDateStruct': {'date': '2006-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-03-28', 'studyFirstSubmitDate': '2008-03-28', 'studyFirstSubmitQcDate': '2008-03-28', 'lastUpdatePostDateStruct': {'date': '2008-04-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-04-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improvement of FEV1', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'Improvement of exercise capacity', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['COPD', 'Emphysema', 'thorax enlargement', 'LVRS'], 'conditions': ['COPD', 'Emphysema']}, 'descriptionModule': {'briefSummary': 'There is a growing population of end-stage COPD patients for whom surgical treatments like lung transplantation and lung volume reduction surgery are not possible. In such patients, size mismatch between large emphysematous lungs and a restricted chest wall is a major cause for the reduction of dynamic lung volumes and consequent dyspnea. We hypothesized that enlargement of the thorax would be a potential alternative strategy to volume reduction surgery as it may improve lung mechanics by resizing the chest to the lung and does not further deprive patients from lung tissue which is already scarce.', 'detailedDescription': "Lung volume reduction surgery primarily increases vital capacity by reducing RV more than TLC. As the chest wall is the major TLC limiting factor, an alternative approach that could circumvent size mismatch would be a surgical enlargement of the thorax cavity. Any post-operative increase of TLC would allow greater dynamic operational lung volumes to occur with an equal amount of dead space. Moreover, resizing of the thorax would have a tremendous advantage over resizing of the lung, in that it would not require resection of the lung in patients in whom lung tissue is already scarce. Chest expansion will only be guaranteed if the sternal widening osteotomy will obtain a solid union. Small poly-ether-ether-keton (PEEK) cages were designed to match both sternal halves in a 'press fit' way, which were filled with lyophilised bone and fixed with extra wires as in a classical sternotomy. These bone-filled cages function as a perfect matrix for progressive in-growth of cancellous bone."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\npatients with end-stage emphysema and\n\n* Disabling dyspnea\n* GOLD III or IV\n* Residual volume \\> 200% predicted\n* Total Lung capacity \\> 120% predicted\n* RV/TLC \\> 0.6\n* Resting CO2 \\< 50 mmHg\n* diffusion capacity \\> 20% predicted\n* age \\< 70 years\n\nExclusion Criteria:\n\n* previous sternotomy\n* contraindication of general anesthesia\n* chronic treatment with corticosteroids\n* any tobacco use within 6 months\n* candidates for lung volume reduction surgery or lung transplantation'}, 'identificationModule': {'nctId': 'NCT00650559', 'acronym': 'TE', 'briefTitle': 'Thorax Enlarging Surgery: a Novel Surgical Approach to Emphysema', 'organization': {'class': 'OTHER', 'fullName': 'KU Leuven'}, 'officialTitle': 'Chest Wall Enlargement by Widening Sternotomy in Patients With Severe Emphysema: a Feasibility Trial.', 'orgStudyIdInfo': {'id': 'TE-001'}, 'secondaryIdInfos': [{'id': 'No grants or contracts'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Experimental surgical intervention.', 'interventionNames': ['Procedure: Chest wall enlargement']}], 'interventions': [{'name': 'Chest wall enlargement', 'type': 'PROCEDURE', 'otherNames': ['PEEK cages'], 'description': 'Widening sternotomy', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3000', 'city': 'Leuven', 'state': 'Flanders', 'country': 'Belgium', 'facility': 'University hospital Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}], 'overallOfficials': [{'name': 'Marc Decramer, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitaire Ziekenhuizen KU Leuven'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'KU Leuven', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Marc Decramer', 'oldOrganization': 'University Hospital Leuven'}}}}