Ignite Creation Date:
2025-12-25 @ 2:56 AM
Ignite Modification Date:
2026-04-11 @ 8:44 PM
Study NCT ID:
NCT06685133
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-08-15
First Post:
2024-11-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Evaluation of the Tool-in-lesion Technology of the Galaxy System in Routine Clinical Practice
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-11-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2027-10-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-13', 'studyFirstSubmitDate': '2024-11-09', 'studyFirstSubmitQcDate': '2024-11-09', 'lastUpdatePostDateStruct': {'date': '2025-08-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Successful Navigation to the lesion', 'timeFrame': 'During the procedure', 'description': 'Placing the scope in an adequate location which the physician operator judges as suitable to initiate biopsy.'}, {'measure': 'Successful tool-in-lesion', 'timeFrame': 'During the procedure', 'description': 'Successful tool-in-lesion (defined as the tool within the lesion) as confirmed by CBCT.'}, {'measure': 'Serious Adverse Events', 'timeFrame': 'During the procedure and up to 7 days post procedure', 'description': 'Serious device or procedure related adverse events'}], 'secondaryOutcomes': [{'measure': 'Diagnostic yield', 'timeFrame': 'End of procedure and up to 2-years post-procedure', 'description': 'Number of patients who are provided a definitive diagnosis based on the pathology report of the biopsied tissue.'}, {'measure': 'Center Strike', 'timeFrame': 'During the procedure', 'description': 'Center strike (defined as inner one-third of lesion from all 3 views (axial, sagittal, and coronal) confirmed by CBCT.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Lung Cancer', 'Lung; Nodule']}, 'descriptionModule': {'briefSummary': 'A prospective observational study evaluating the accuracy of the tool-in-lesion technology of the Galaxy SystemTM in normal clinical practice.', 'detailedDescription': 'The goal of this study is to collect clinical data from eligible subjects in routine clinical practice to confirm the safety and effectiveness of the Galaxy SystemTM with integrated tool-in-lesion tomography (TiLT+) in bronchoscopically biopsying small peripheral pulmonary nodules.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Clinic patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥ 18\n2. Patients with indeterminate lung nodule\n3. Peripheral pulmonary subsolid and solid nodules (PPNs) sized up to 3 cm measured as the largest dimension based on the pre-procedural CT\n4. Pre-procedural CT is conducted within 90 days of the bronchoscopy procedure\n5. Informed consent properly obtained per local regulations\n\nExclusion Criteria:\n\n1. Known pregnancy or breastfeeding\n2. Patients with pure ground-glass nodules on pre-procedural chest CT\n3. Uncontrolled coagulopathy or bleeding disorders\n4. Ongoing systemic infection\n5. History of lobectomy or pneumonectomy\n6. Patients with pacemakers or defibrillators\n7. Unsuitable for bronchoscopy procedure under general anesthesia as agreed by the treating clinician and anesthetist\n8. Patients with pleural effusion or diaphragmatic paralysis'}, 'identificationModule': {'nctId': 'NCT06685133', 'acronym': 'Match 2', 'briefTitle': 'Prospective Evaluation of the Tool-in-lesion Technology of the Galaxy System in Routine Clinical Practice', 'organization': {'class': 'INDUSTRY', 'fullName': 'Noah Medical'}, 'officialTitle': 'A Prospective Observational Study Evaluating the Accuracy of the Tool-in-lesion Technology of the Galaxy SystemTM in Normal Clinical Practice', 'orgStudyIdInfo': {'id': 'NOAH-003'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Intervention/Treatment', 'description': 'Subjects who undergo bronchoscopy of the airways using the Galaxy System.', 'interventionNames': ['Device: Robotic assisted bronchoscopy']}], 'interventions': [{'name': 'Robotic assisted bronchoscopy', 'type': 'DEVICE', 'description': 'Subjects will undergo a robotic navigated bronchoscopy to biopsy peripheral pulmonary nodules.', 'armGroupLabels': ['Intervention/Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37404', 'city': 'Chattanooga', 'state': 'Tennessee', 'country': 'United States', 'facility': 'CHI Memorial Hospital', 'geoPoint': {'lat': 35.04563, 'lon': -85.30968}}, {'zip': '22042', 'city': 'Falls Church', 'state': 'Virginia', 'country': 'United States', 'facility': 'Inova Fairfax Medical Campus', 'geoPoint': {'lat': 38.88233, 'lon': -77.17109}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Noah Medical', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}