Ignite Creation Date:
2025-12-24 @ 2:07 PM
Ignite Modification Date:
2025-12-27 @ 10:45 PM
Study NCT ID:
NCT05562895
Status:
COMPLETED
Last Update Posted:
2025-11-13
First Post:
2022-09-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Multicenter Study to Evaluate the Cios Spin and the Ion Endoluminal System for Pulmonary Nodule Biopsy
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': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 155}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-11', 'studyFirstSubmitDate': '2022-09-28', 'studyFirstSubmitQcDate': '2022-09-28', 'lastUpdatePostDateStruct': {'date': '2025-11-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-10-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnostic yield', 'timeFrame': 'Intra-procedure through the 13 month follow up period', 'description': 'Defined as the sum of true positives and true negatives divided by the total number of nodules (or subjects) biopsied'}, {'measure': 'Sensitivity for malignancy', 'timeFrame': 'Intra-procedure through the 13 month follow up period', 'description': 'Defined as the number of true positives divided by the sum of true positives and false negatives for malignancy'}, {'measure': 'Rate of tool in nodule', 'timeFrame': 'Intra-procedure', 'description': 'Tool in nodule is defined as any portion of the needle visualized within the target in all 3 axes (must be confirmed with 3D imaging)'}], 'secondaryOutcomes': [{'measure': 'Total radiation dose', 'timeFrame': 'Intra-procedure', 'description': 'Radiation dose from biopsy procedure, measured by the dose area product (DAP), defined as the product of dose and beam area (Gy cm\\^2)'}, {'measure': 'Time to achieve tool in nodule', 'timeFrame': 'Intra-procedure', 'description': 'Defined as the time the Ion catheter crosses the endotracheal tube (ETT) to the time tool in nodule is confirmed with 3D imaging'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Lung Cancer']}, 'descriptionModule': {'briefSummary': 'The overall objective of this study is to evaluate procedure characteristics of pulmonary nodule biopsies using the integrated version of Cios Spin and the Ion Endoluminal System.', 'detailedDescription': 'This study is a post-market, prospective, multicenter, single-arm study of subjects undergoing a pulmonary nodule biopsy using the Ion Endoluminal System in conjunction with the Cios Spin. The aim of the study is to evaluate the integrated version of the two systems. The primary outcomes of the study are focused on evaluating the procedure characteristics of the pulmonary nodule biopsy procedure, including diagnostic yield, sensitivity for malignancy, and rate of tool in nodule.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects with an attempted or performed pulmonary nodule biopsy using the Ion Endoluminal System and Cios Spin, 18 years or older', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject is 18 years or older at the time of the procedure.\n* Pulmonary nodule biopsy attempted/performed using the Ion Endoluminal System and Cios Spin 3D imaging.\n* Pulmonary nodule ≤2 cm in largest diameter.\n* Subject able to understand and adhere to study requirements and provide informed consent.\n\nExclusion Criteria:\n\n* Planned lymph node staging performed before nodule biopsy.\n* Nodule is a pure ground glass opacity.\n* Plan to biopsy multiple nodules.'}, 'identificationModule': {'nctId': 'NCT05562895', 'briefTitle': 'A Multicenter Study to Evaluate the Cios Spin and the Ion Endoluminal System for Pulmonary Nodule Biopsy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Intuitive Surgical'}, 'officialTitle': 'A Multicenter Study to Evaluate the Cios Spin and the Ion Endoluminal System for Pulmonary Nodule Biopsy', 'orgStudyIdInfo': {'id': 'ISI-ION-002'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Subjects with biopsy of pulmonary nodule using Ion Endoluminal System and Cios Spin', 'description': 'Subjects in which a pulmonary nodule biopsy was attempted or performed with the integrated Ion Endoluminal System and Cios Spin', 'interventionNames': ['Device: Ion Endoluminal System and Cios Spin']}], 'interventions': [{'name': 'Ion Endoluminal System and Cios Spin', 'type': 'DEVICE', 'description': 'Integrated version of the Ion Endoluminal System and Cios Spin', 'armGroupLabels': ['Subjects with biopsy of pulmonary nodule using Ion Endoluminal System and Cios Spin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '92103', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'University of California San Diego, Hillcrest Medical Center', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic - Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '78704', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'South Austin Hospital', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Roberto Casal, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'MD Anderson'}, {'name': 'Bryan Husta, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Memorial Sloan Kettering Cancer Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Intuitive Surgical', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}