Ignite Creation Date:
2025-12-25 @ 12:54 AM
Ignite Modification Date:
2025-12-25 @ 11:09 PM
Study NCT ID:
NCT06036667
Status:
COMPLETED
Last Update Posted:
2024-02-28
First Post:
2023-02-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of Coaxial Smart Drain (Redax TM) in Uniportal-VATS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010996', 'term': 'Pleural Effusion'}], 'ancestors': [{'id': 'D010995', 'term': 'Pleural Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 178}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2023-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-26', 'studyFirstSubmitDate': '2023-02-21', 'studyFirstSubmitQcDate': '2023-09-12', 'lastUpdatePostDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fluid output 1', 'timeFrame': 'At 24 hours from surgery', 'description': 'Total fluid amount'}, {'measure': 'Fluid output 2', 'timeFrame': 'At 48 hours from surgery', 'description': 'Total fluid amount'}, {'measure': 'Fluid output 3', 'timeFrame': 'At 72 hours from surgery', 'description': 'Total fluid amount'}, {'measure': 'Fluid output 4', 'timeFrame': 'At 96 hours from surgery', 'description': 'Total fluid amount'}, {'measure': 'Residual pleural effusion at chest X-Ray', 'timeFrame': '72 hours after surgery', 'description': 'Residual pleural effusion at chest X-Ray before chest tube removal. The entity of pleural effusion is measured as "intercostal spaces", counted on posterior costal arches'}, {'measure': 'subcutaneous emphysema 1', 'timeFrame': 'At 24 hours after surgery', 'description': 'incidence of subcutaneous emphysema'}, {'measure': 'subcutaneous emphysema 2', 'timeFrame': 'At 48 hours after surgery', 'description': 'incidence of subcutaneous emphysema'}, {'measure': 'subcutaneous emphysema 3', 'timeFrame': 'At 72 hours after surgery', 'description': 'incidence of subcutaneous emphysema'}], 'secondaryOutcomes': [{'measure': 'Tube obstruction', 'timeFrame': 'during chest tube removal procedure', 'description': 'tube obstructed by blood clots'}, {'measure': 'Pain related to chest tube 1', 'timeFrame': 'At 24 hours after surgery', 'description': 'Pain measured in each postoperative day on VAS scale (Visual Analogue Scale, range:from 0 to 10; VAS\\>4 and \\<10 indicates moderate to severe pain)'}, {'measure': 'Pain related to chest tube 2', 'timeFrame': 'At 48 hours after surgery', 'description': 'Pain measured in each postoperative day on VAS scale (Visual Analogue Scale, range:from 0 to 10; VAS\\>4 and \\<10 indicates moderate to severe pain)'}, {'measure': 'Pain related to chest tube 3', 'timeFrame': 'At 72 hours after surgery', 'description': 'Pain measured in each postoperative day on VAS scale (Visual Analogue Scale, range:from 0 to 10; VAS\\>4 and \\<10 indicates moderate to severe pain)'}, {'measure': 'Pain related to chest tube 4', 'timeFrame': 'At 96 hours after surgery', 'description': 'Pain measured in each postoperative day on VAS scale (Visual Analogue Scale, range:from 0 to 10; VAS\\>4 and \\<10 indicates moderate to severe pain)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pleural Effusion', 'Video Assisted Thoracic Surgery', 'Chest Tubes']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to evaluate efficacy and safety of "Smart Coaxial drain" (Redax TM, Poggio Rusco, Mantova, Italia) in terms of total amount of effusion drained, incidence of residual effusion at Chest X-Ray and patient\'s comfort in Uniportal- and Biportal-VATS upper lobectomies.\n\nIn particular, to evaluate in Uniportal-VATS upper lobectomies the efficacy and safety of smart coaxial drains compared with standard silicone chest tubes.', 'detailedDescription': 'At the end of lung surgery, usually surgeons placed one or more chest tubes. There are several types of chest tubes and the type used by surgeons depends on centre avaiability/ local practice or surgeon choice etc...Coaxial smart drains are used in clinical practice since several years in Thoracic Surgery. In thoracoscopic (VATS) surgery usually only one chest tube is placed. In this study, we evaluate the efficacy of placement of 28Fr "coaxial smart drain" chest tube versus 28 Fr standard chest tube after Uniportal- or Biportal-VATS upper lobectomies in terms of total amount of effusion drained, incidence of residual effusion at Chest X-Ray and patient\'s confort.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergone upper right or left lobectomy in Uniportal- or Biportal-VATS\n\nExclusion Criteria:\n\n* Patients undergone open surgery\n* Patients undergone middle or lower lobectomies\n* Patients undergone chest wall/or wedge resections'}, 'identificationModule': {'nctId': 'NCT06036667', 'briefTitle': 'Safety and Efficacy of Coaxial Smart Drain (Redax TM) in Uniportal-VATS', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS'}, 'officialTitle': 'Safety and Efficacy of Coaxial Smart Drain (Redax TM) in Uniportal-VATS', 'orgStudyIdInfo': {'id': 'ID 2388'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Study group', 'description': 'All patients undergone Uniportal-VATS upper lobectomy with 28Fr Smart Coaxial drain placed at the end of surgery', 'interventionNames': ['Procedure: 28Fr "coaxial smart drain" chest tube']}, {'type': 'NO_INTERVENTION', 'label': 'Study group 1', 'description': 'All patients undergone Uniportal-VATS upper lobectomy with standard 28Fr chest drain placed at the end of surgery'}, {'type': 'EXPERIMENTAL', 'label': 'Study group 2', 'description': 'All patients undergone Biportal-VATS upper lobectomy with 28Fr Smart Coaxial drain placed at the end of surgery', 'interventionNames': ['Procedure: 28Fr "coaxial smart drain" chest tube']}], 'interventions': [{'name': '28Fr "coaxial smart drain" chest tube', 'type': 'PROCEDURE', 'description': 'To evaluate the efficacy of one 28Fr chest tube ("coaxial smart drain" versus standard chest tube according to local practice, types of drainage availability in each centre, surgeon\'s choice etc) after Uniportal- or Biportal-VATS upper lobectomies.', 'armGroupLabels': ['Study group', 'Study group 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00168', 'city': 'Roma', 'country': 'Italy', 'facility': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}], 'overallOfficials': [{'name': 'Dania Nachira, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}