Ignite Creation Date:
2025-12-24 @ 1:06 PM
Ignite Modification Date:
2025-12-28 @ 12:30 AM
Study NCT ID:
NCT07136961
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-08-22
First Post:
2025-08-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Robotic-assisted Bronchoscopy Combined With the ICNVA Strategy in Biopsy of Peripheral Pulmonary Nodules
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065854', 'term': 'Spatial Navigation'}], 'ancestors': [{'id': 'D013037', 'term': 'Spatial Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-12-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-10-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-15', 'studyFirstSubmitDate': '2025-08-09', 'studyFirstSubmitQcDate': '2025-08-15', 'lastUpdatePostDateStruct': {'date': '2025-08-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tool-in-lesion rate', 'timeFrame': 'Perioperative/Periprocedural'}], 'secondaryOutcomes': [{'measure': 'Center Strike rate', 'timeFrame': 'Perioperative/Periprocedural'}, {'measure': 'Tool-touch-lesion rate', 'timeFrame': 'Perioperative/Periprocedural'}, {'measure': 'Successful diagnosis rate', 'timeFrame': 'Perioperative/Periprocedural'}, {'measure': 'Lesion detection rate', 'timeFrame': 'Perioperative/Periprocedural'}, {'measure': 'Bronchopulmonary hemorrhage rate', 'timeFrame': 'Perioperative/Periprocedural'}, {'measure': 'Pneumothorax rate', 'timeFrame': 'Perioperative/Periprocedural'}, {'measure': 'CT to Body divergence（CTBD）', 'timeFrame': 'Perioperative/Periprocedural', 'description': 'The difference between the distance from the probe to the center of the target nodule in Robotic-Assisted Bronchoscopy and the actual distance from the probe to the target nodule center in follow-up Computed Tomography'}, {'measure': 'Successful operation rate', 'timeFrame': 'Perioperative/Periprocedural'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['bronchial navigation and positioning'], 'conditions': ['Lung Nodules', 'Biopsy', 'Navigation, Spatial']}, 'descriptionModule': {'briefSummary': 'To assess the efficacy and safety of robotic-assisted bronchoscopy system (bronchial navigation and positioning device) combined with ICNVA strategy for peripheral pulmonary nodule biopsy through a prospective, single-center, single-arm study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥18 years old, and ≤75 years old, male or female;\n2. Patients with peripheral lung lesions found by chest CT, whose diameter ≥ 6mm and \\< 3cm, who plan to undergo robotic-assisted bronchoscopic for pulmonary biopsy;\n3. The patient voluntarily undergo bronchoscopy and meet the requirements for bronchoscopy;\n4. Patients can understand the purpose of the trial, have good compliance with the examination and follow-up, voluntarily participate in the clinical trial and sign the informed consent.\n\nExclusion Criteria:\n\n1. Patients with cardiovascular diseases, such as blood pressure instability, myocardial infarction or arrhythmia;\n2. Patients with massive hemoptysis within two weeks;\n3. Patients with severe pneumothorax and rib fracture;\n4. Patients with serious infectious diseases, such as tuberculosis or AIDS;\n5. Patients with severe abdominal aortic aneurysm or thoracic aortic aneurysm;\n6. Participants who have participated in or are participating in drug clinical trials within 3 months before screening, or have participated in other medical device clinical trials within 30 days;\n7. Those who were not considered suitable for inclusion by the researchers.'}, 'identificationModule': {'nctId': 'NCT07136961', 'briefTitle': 'Efficacy and Safety of Robotic-assisted Bronchoscopy Combined With the ICNVA Strategy in Biopsy of Peripheral Pulmonary Nodules', 'organization': {'class': 'OTHER', 'fullName': 'The First Affiliated Hospital of Nanchang University'}, 'officialTitle': 'Efficacy and Safety of Robotic-assisted Bronchoscopy Combined With the ICNVA Strategy in Biopsy of Peripheral Pulmonary Nodules: A Prospective, Single-center, Single-arm Study', 'orgStudyIdInfo': {'id': 'DSH1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Robot-Assisted Bronchoscopy (RAB)', 'description': '1. Preoxygenation \\& Navigation Registration\n2. Robotic-Guided Navigation\n3. Puncture Tunnel Establishment\n4. Position Verification \\& Adjustment\n\n Perform confirmatory CT scan to assess tool-nodule relationship:\n\n Tool-in-lesion (TIL) : Biopsy tool penetrates nodule Center Strike : Tool tip reaches central 1/3 of nodule (coronal/sagittal/horizontal planes) Tool-touch-lesion : Tool contacts but does not enter nodule\n * 4mm deviation : Proceed to biopsy \\>4mm deviation : Adjust based on operator judgment\n5. Biopsy \\& Rapid Evaluation Obtain tissue samples Conduct ROSE (Rapid On-Site Evaluation) to guide next steps\n6. Post-Procedure Safety Check Perform postoperative CT to exclude pneumothorax/hemorrhage Maintain identical ventilation settings during imaging and biopsy phases to prevent target shift', 'interventionNames': ['Procedure: Robot-Assisted Bronchoscopy (RAB)']}], 'interventions': [{'name': 'Robot-Assisted Bronchoscopy (RAB)', 'type': 'PROCEDURE', 'description': '1. Preoxygenation \\& Navigation Registration\n2. Robotic-Guided Navigation\n3. Puncture Tunnel Establishment\n4. Position Verification \\& Adjustment\n\n Perform confirmatory CT scan to assess tool-nodule relationship:\n\n Tool-in-lesion (TIL) : Biopsy tool penetrates nodule Center Strike : Tool tip reaches central 1/3 of nodule (coronal/sagittal/horizontal planes) Tool-touch-lesion : Tool contacts but does not enter nodule\n * 4mm deviation : Proceed to biopsy \\>4mm deviation : Adjust based on operator judgment\n5. Biopsy \\& Rapid Evaluation Obtain tissue samples Conduct ROSE (Rapid On-Site Evaluation) to guide next steps\n6. Post-Procedure Safety Check Perform postoperative CT to exclude pneumothorax/hemorrhage Maintain identical ventilation settings during imaging and biopsy phases to prevent target shift', 'armGroupLabels': ['Robot-Assisted Bronchoscopy (RAB)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '330006', 'city': 'Nanchang', 'state': 'Jiangxi', 'country': 'China', 'facility': 'The First Affiliated Hospital of Nanchang University', 'geoPoint': {'lat': 28.68396, 'lon': 115.85306}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The First Affiliated Hospital of Nanchang University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D., Ph.D, Professor', 'investigatorFullName': 'Shaohua Dai', 'investigatorAffiliation': 'The First Affiliated Hospital of Nanchang University'}}}}