Ignite Creation Date:
2025-12-24 @ 9:22 PM
Ignite Modification Date:
2026-01-01 @ 1:52 AM
Study NCT ID:
NCT06597604
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-02-03
First Post:
2024-09-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Effectiveness and Security of TenaTac® in the Prevention of Air Leaks in Thoracic Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D013510', 'term': 'Pulmonary Surgical Procedures'}], 'ancestors': [{'id': 'D019616', 'term': 'Thoracic Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 154}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-30', 'studyFirstSubmitDate': '2024-09-12', 'studyFirstSubmitQcDate': '2024-09-16', 'lastUpdatePostDateStruct': {'date': '2025-02-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To compare the effectiveness of the TenaTac® patch on the duration of thoracic drainage for each patient (regardless of their degree of emphysema) compared to sealing devices routinely used by thoracic surgeons for the same indication', 'timeFrame': '4 weeks', 'description': 'Assess the effectiveness of the TenaTac® patch in terms of duration of thoracic drainage, compared with sealing devices routinely used by thoracic surgeons for the same indication.'}], 'secondaryOutcomes': [{'measure': 'To assess the effectiveness of the TenaTac® patch in preventing postoperative air leaks throughout the hospital stay, and more specifically in PALs (beyond the 5th day).', 'timeFrame': '4 weeks', 'description': 'Assess the effectiveness of the TenaTac® patch in terms of PAL rates decrease compared to those measured with the other sealants routinely used by thoracic surgeons for the same indication and in the same circumstances'}, {'measure': 'Effectiveness of the TenaTac® patch in reducing hospital stay', 'timeFrame': '4 weeks', 'description': 'Assess the effectiveness of the TenaTac® patch in reducing hospital stay, compared to those obtained with the other sealants routinely used by thoracic surgeons for the same indication and in the same circumstances'}, {'measure': 'Effectiveness of the TenaTac® patch in preventing (immediate and medium term) postoperative complications', 'timeFrame': '4 weeks', 'description': 'Assess the effectiveness of the TenaTac® patch in preventing (immediate and medium term) postoperative complications, compared to those declared with the other sealants routinely used by thoracic surgeons for the same indication and in the same circumstances'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Lung surgery', 'TenaTac', 'Gelatin Patch', 'Sealant', 'PAL', 'Pulmonary Air Leak', 'Lobectomy'], 'conditions': ['Lung Surgery']}, 'descriptionModule': {'briefSummary': 'Lung surgery remains a high-risk procedure, with serious adverse events that can occur later, including postoperative bleeding or hemothorax, pneumopathy or surgical site infection but also ... per- and post-operative air leaks. Majority the air leaks resolve spontaneously within 48 hours but certain cases persist within several days which known as prolonged air leaks, or PAL. Several safe and effective sealing agents are used to contain and or reduce the intensity and incidence of postoperative air leaks, and the time required for drain removal. This protocol assesses the effectiveness of an innovative gelatin-based medical device named TenaTac® (Selentus Science, UK) in preventing air leak after major lung resection.', 'detailedDescription': 'Thoracic surgery is a specialty dedicated to the management (diagnosis and treatment...) of conditions and lesions of the thoracic cage and its organs, excluding the heart, aorta and esophagus. It is based on 2 surgical techniques: open (by posterolateral thoracotomy) or minimally invasive endoscopic (with or without robot-assisted surgery).\n\nLobectomy is the most common pulmonary resection, however, regardless of the surgical option chosen, lung surgery remains a high-risk procedure, with serious adverse events that can occur later, including postoperative bleeding or hemothorax, pneumopathy or surgical site infection, pulmonary alveolar collapse, acute respiratory distress syndrome, pleural or pericardial effusion, lobar torsion or multi-organ failure, bronchial or esophageal fistulas, transient arrhythmia due to vagus nerve damage, pulmonary embolism, venous ischemia, ... and, per- and post-operative air leaks. Air leak has been reported in 25-75% of patients, which makes it the most common incident after elective lung surgery.\n\nAlthough the majority of these air leaks resolve spontaneously within 48 hours (by continuous pleural drainage), certain cases persist for several days (more than 5 days). These are known as prolonged air leaks, or PAL.\n\nThe literature describes several sealing agents used to contain air leaks. The preventive use of sealants at the lung resection site seems safe and effective, since it significantly reduces the intensity and incidence of postoperative air leaks, and the time required for drain removal, Pharmaceutical gelatin-based medical devices, used for decades for their hemostatic properties, have recently been suggested for sealing pulmonary defects and preventing air leaks. Regarding the results obtained, gelatin appears to be a therapeutically effective biomaterial in lung surgery. We therefore hypothesize the effectiveness of the innovative medical device TenaTac® (Selentus Science, UK) in preventing air leak after major lung resection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients hospitalized in the thoracic surgery departments of the investigating centers, for elective surgery,\n* Lobectomy surgery requiring the use of a sealing agent,\n* Adult patients (\\>18 years),\n* Patients who have given written consent to participate in the study,\n* Patients registered within the social security insurance in France.\n\nExclusion Criteria:\n\n* Patients hospitalized in emergency,\n* Patients with gelatin allergy,\n* Patients undergoing other biomedical research likely to interfere with the evaluation criteria of this study\n* Patients under tutorship and/or curatorship,\n* Patients unable to follow the planned post-operative follow-up,\n* Patients whose life expectancy is less than 1 year,\n* Pregnant or breast-feeding patients.'}, 'identificationModule': {'nctId': 'NCT06597604', 'acronym': 'TENATAC', 'briefTitle': 'Evaluation of the Effectiveness and Security of TenaTac® in the Prevention of Air Leaks in Thoracic Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Hopitaux Prives de Metz, Groupe UNEOS'}, 'officialTitle': 'Evaluation of the Effectiveness and Security of TenaTac® in the Prevention of Air Leaks in Thoracic Surgery', 'orgStudyIdInfo': {'id': 'PI-2024-002'}, 'secondaryIdInfos': [{'id': '2024-A01716-41', 'type': 'OTHER', 'domain': 'ID-RCB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental Group', 'description': 'Thoracic Surgeons will apply the experimental device TenaTac® after major lung resection', 'interventionNames': ['Device: Intraoperative use of TenaTac in lung surgery']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group', 'description': 'Thoracic Surgeons will apply other (usual) sealing device after major lung resection', 'interventionNames': ['Device: Intraoperative use of usual sealant in lung surgery']}], 'interventions': [{'name': 'Intraoperative use of TenaTac in lung surgery', 'type': 'DEVICE', 'description': 'Use of innovative medical device : TenaTac', 'armGroupLabels': ['Experimental Group']}, {'name': 'Intraoperative use of usual sealant in lung surgery', 'type': 'DEVICE', 'description': 'Use of the usual scealant as a control', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '57000', 'city': 'Metz', 'state': 'Grand Est', 'country': 'France', 'contacts': [{'name': 'Sofiane Saada, PhD', 'role': 'CONTACT', 'email': 'sofiane.saada@uneos.fr', 'phone': '+33357843376', 'phoneExt': '+33'}, {'name': 'Alessandro ORSINI, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hôpital Robert Schuman_Groupe UNEOS', 'geoPoint': {'lat': 49.11911, 'lon': 6.17269}}, {'zip': '64100', 'city': 'Bayonne', 'country': 'France', 'contacts': [{'name': 'Caroline RIVERA, MD', 'role': 'CONTACT', 'email': 'crivera@ch-cotebasque.fr', 'phone': '+33559443502', 'phoneExt': '+33'}, {'name': 'Caroline RIVERA, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centre Hospitalier de la Côte Basque (Bayonne)', 'geoPoint': {'lat': 43.49316, 'lon': -1.473}}], 'centralContacts': [{'name': 'Sofiane Saada, PhD', 'role': 'CONTACT', 'email': 'sofiane.saada@uneos.fr', 'phone': '+33357843376', 'phoneExt': '+33'}, {'name': 'Alessandro ORSINI, MD', 'role': 'CONTACT', 'email': 'alessandro.orsini@uneos.fr', 'phone': '+33357842227', 'phoneExt': '+33'}], 'overallOfficials': [{'name': 'Alessandro ORSINI, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hôpitaux Privés de Metz, Groupe UNEOS'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Data collected throughout the trial used in the results publication will be shared with other researchers'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hopitaux Prives de Metz, Groupe UNEOS', 'class': 'OTHER'}, 'collaborators': [{'name': 'CuraMedrix B.V.', 'class': 'UNKNOWN'}, {'name': 'Medical Advices Consulting', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}