Ignite Creation Date:
2025-12-25 @ 2:41 AM
Ignite Modification Date:
2025-12-29 @ 12:25 AM
Study NCT ID:
NCT05714033
Status:
RECRUITING
Last Update Posted:
2025-05-06
First Post:
2023-01-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Randomized Trial Comparing a Ventilatory Strategy To Prevent Atelectasis Versus a Lateral Decubitus Strategy During Robotic Bronchoscopy (VESPA vs. LADS Trial)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-02-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2032-09-14', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-01', 'studyFirstSubmitDate': '2023-01-26', 'studyFirstSubmitQcDate': '2023-01-26', 'lastUpdatePostDateStruct': {'date': '2025-05-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2032-09-14', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0', 'timeFrame': 'through study completion; an average of 1 year.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pulmonary', 'Lung']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mdanderson.org', 'label': 'M D Anderson Cancer Center'}]}, 'descriptionModule': {'briefSummary': 'To learn if LADS is better than VESPA at preventing atelectasis during a robotic bronchoscopy.', 'detailedDescription': 'Primary Objective:\n\nTo compare the proportion of patients developing target-obscuring atelectasis when using a lateral decubitus strategy (LADS) vs using a ventilatory strategy to prevent atelectasis (VESPA) during robotic bronchoscopy for posteriorly-located peripheral lung lesions.\n\nSecondary Objectives:\n\n* To compare the proportion of patients with atelectasis in the target lobe in VESPA vs. LADS during robotic bronchoscopy.\n* To compare the proportion of patients with atelectasis obscuring 100%, 50% or more, and less than 50% of the target during robotic bronchoscopy using LADS vs. VESPA.\n* To compare the proportion of patients in whom a biopsy sample was not taken due to atelectasis using LADS vs. VESPA.\n* To compare the diagnostic yield using LADS vs. VESPA.\n* To compare the proportion of tool in lesion (TIL) using LADS vs. VESPA.\n* To compare the diagnostic accuracy (sensitivity and specificity) for malignancy using LADS vs. VESPA.\n* To compare the proportion of LADS-induced vs. VESPA-induced complications.\n* To compare the proportion of bronchoscopy-induced complications in LADS vs. VESPA.\n* To compare the accuracy of 3D-2D image registration using LADS vs. VESPA.\n* To compare clinical workflow in robotic bronchoscopy with VESPA and LADS strategies to identify potential improvements in workflow.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adult patients (≥ 18 years old) undergoing diagnostic robotic bronchoscopy for a lung nodule suspicious for malignancy bronchoscopy under general anesthesia.\n2. Lung nodules should be up to 3 cm in diameter and located in right or left bronchial segments B2, B6, B9, and B10. Greater than 50% of the volume of the lesion needs to be below a horizontal line traced at the most anterior edge of the corresponding vertebral body.\n3. Chest CT performed \\< 45 days prior to bronchoscopy.\n4. Voluntary informed consent to participate in the study.\n\nExclusion Criteria:\n\n1. Patients with prior lung consolidation, interstitial changes or lung masses (\\> 3 cm in diameter) as seen on most recent CT\n2. Lesions outside of the designated lung areas defined as inclusion criteria.\n3. Known pregnancy\n4. Vulnerable population\n5. Ascites\n6. Known diaphragmatic paralysis\n7. Smokers or ex-smokers with known or suspected severe air-trapping defined as residual volume \\> 150% of predicted\n8. History of primary or secondary spontaneous pneumothorax\n9. Lung bullae \\> 5 cm\n10. Patients with mediastinal or hilar adenopathy with high suspicion for malignancy in whom lymph node sampling is indicated and should occur prior to robotic bronchoscopy of the peripheral lesion.\n11. Patient with active COVID pneumonia.'}, 'identificationModule': {'nctId': 'NCT05714033', 'briefTitle': 'A Randomized Trial Comparing a Ventilatory Strategy To Prevent Atelectasis Versus a Lateral Decubitus Strategy During Robotic Bronchoscopy (VESPA vs. LADS Trial)', 'organization': {'class': 'OTHER', 'fullName': 'M.D. Anderson Cancer Center'}, 'officialTitle': 'A Randomized Trial Comparing a Ventilatory Strategy To Prevent Atelectasis Versus a Lateral Decubitus Strategy During Robotic Bronchoscopy (VESPA vs. LADS Trial)', 'orgStudyIdInfo': {'id': '2022-0756'}, 'secondaryIdInfos': [{'id': 'NCI-2023-00783', 'type': 'OTHER', 'domain': 'NCI CTRP Clinical Trials Registry'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1', 'description': 'Group 1, Participants will receive VESAP during the bronchoscopy. Ventilatory Strategy To Prevent Atelectasis versus a Lateral Decubitus Strategy During Robotic Bronchoscopy', 'interventionNames': ['Procedure: Ventilatory Strategy To Prevent Atelectasis']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2', 'description': 'Group 2, Participants will receive LADS Lateral Decubitus Strategy During Robotic Bronchoscopy during the bronchoscopy.', 'interventionNames': ['Procedure: Lateral Decubitus Strategy (LADS)']}], 'interventions': [{'name': 'Ventilatory Strategy To Prevent Atelectasis', 'type': 'PROCEDURE', 'description': 'Given', 'armGroupLabels': ['Group 1']}, {'name': 'Lateral Decubitus Strategy (LADS)', 'type': 'PROCEDURE', 'description': 'Given', 'armGroupLabels': ['Group 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Roberto Casal, MD', 'role': 'CONTACT', 'email': 'rfcasal@mdanderson.org', 'phone': '832-287-9479'}, {'name': 'Roberto Casal, Casal', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'M D Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'centralContacts': [{'name': 'Roberto Casal, MD', 'role': 'CONTACT', 'email': 'rfcasal@mdanderson.org', 'phone': '(832) 287-9479'}], 'overallOfficials': [{'name': 'Roberto Casal, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'M.D. Anderson Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}