Ignite Creation Date:
2025-12-24 @ 10:01 PM
Ignite Modification Date:
2025-12-25 @ 7:38 PM
Study NCT ID:
NCT04722432
Status:
COMPLETED
Last Update Posted:
2024-02-02
First Post:
2020-10-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Deployment Capability and Accuracy of an Outside the Scope (OTS), Detachable Catheter System for Ablation of Peripheral Lung Lesions: An Ex-Vivo Human Lung Model Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}], 'ancestors': [{'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2023-09-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-01', 'studyFirstSubmitDate': '2020-10-16', 'studyFirstSubmitQcDate': '2021-01-22', 'lastUpdatePostDateStruct': {'date': '2024-02-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'accuracy of the deployment method', 'timeFrame': 'Time of procedure', 'description': 'will be measured by bidimensional fluoroscopy images (antero-posterior and latero-lateral). The deployment will be considered successful if the tip of the probe is positioned at a distance less than 5 mm in both axes from the target model and stay stable in place over 5 minutes of ventilation.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lung Cancer']}, 'descriptionModule': {'briefSummary': 'A novel OTS detachable probe system carried outside and along the flexible bronchoscope has been developed. Using this novel system, the operator can deploy the probe in the target bronchus and lesion and completely detach the scope from the probe.', 'detailedDescription': 'Lung ablative therapies have growing interest in the treatment of early-stage primary lung cancer in surgical high-risk patients and as part of multimodal treatment in patients with large lesions or metastatic malignant disease in the lungs. Endobronchial ablative strategies allow deliver y of these therapies through a natural orifice and minimally invasive approach, potentially improving safety and reducing related morbidity. Application and deployment of this system allows the operator to have constant control of the airway, preventing life-threatening hemoptysis and other complications. We hypothesize that this novel detachable OTS system can be successfully deployed in the peripheral parenchymal target with potential clinical applications in the near future.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who follow surgery for the removal of diseased lungs before being submitted to a bilateral lung transplant.\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT04722432', 'briefTitle': 'Evaluation of Deployment Capability and Accuracy of an Outside the Scope (OTS), Detachable Catheter System for Ablation of Peripheral Lung Lesions: An Ex-Vivo Human Lung Model Study', 'organization': {'class': 'OTHER', 'fullName': "Centre hospitalier de l'Université de Montréal (CHUM)"}, 'officialTitle': 'Evaluation of Deployment Capability and Accuracy of an Outside the Scope (OTS), Detachable Catheter System for Ablation of Peripheral Lung Lesions: An Ex-Vivo Human Lung Model Study', 'orgStudyIdInfo': {'id': 'CE 20.220'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Système de cathéter détachable dehors du scope (DDS)', 'interventionNames': ['Device: Outside the Scope (OTS), Detachable Catheter System']}], 'interventions': [{'name': 'Outside the Scope (OTS), Detachable Catheter System', 'type': 'DEVICE', 'description': 'Evaluation of Deployment Capability and Accuracy of an Outside the Scope (OTS), Detachable Catheter System for Ablation of Peripheral Lung Lesions: An Ex-Vivo Human Lung Model Study', 'armGroupLabels': ['Système de cathéter détachable dehors du scope (DDS)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'CHUM', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Centre hospitalier de l'Université de Montréal (CHUM)", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}