Ignite Creation Date:
2025-12-26 @ 1:16 PM
Ignite Modification Date:
2025-12-31 @ 9:09 PM
Study NCT ID:
NCT04740606
Status:
UNKNOWN
Last Update Posted:
2021-12-07
First Post:
2021-02-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Airway Navigation Database Asia for Diagnosis of Peripheral Pulmonary Nodules
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Germany']}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-12-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2023-12-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-11-23', 'studyFirstSubmitDate': '2021-02-04', 'studyFirstSubmitQcDate': '2021-02-04', 'lastUpdatePostDateStruct': {'date': '2021-12-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnostic yield', 'timeFrame': 'twelve months', 'description': 'It is defined as the percentage of patients who get definitive diagnosis via bronchoscope biopsy guided by intra-airway navigation system.'}], 'secondaryOutcomes': [{'measure': 'Diagnostic yield', 'timeFrame': 'Twelve months', 'description': 'It is defined as the percentage of patients who get definitive diagnosis via bronchoscope biopsy guided by intra-airway navigation system.'}, {'measure': 'Success rate of biopsy', 'timeFrame': 'Immediately after Each Operation', 'description': 'It is defined as the percentage of nodules with successful biopsy.'}, {'measure': 'Navigation success rate', 'timeFrame': 'Immediately after Each Operation', 'description': 'It is defined as the percentage of nodules whose arrival is confirmed by endobronchial ultrasound (and/or fluoroscopy, or direct bronchoscopy).'}, {'measure': 'Total navigation time', 'timeFrame': 'Immediately after Each Operation', 'description': 'It is defined as the total time from the beginning of navigation to the end of navigation.'}, {'measure': 'Bronchoscope operation time', 'timeFrame': 'Immediately after each operation', 'description': 'It is defined as the total time of bronchoscope insertion to bronchoscope withdrawal.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Augmented Reality Navigation System', 'Peripheral Pulmonary Nodules', 'biopsy'], 'conditions': ['Lung; Node']}, 'descriptionModule': {'briefSummary': 'The study is designed to evaluate the efficacy and safety of Augmented Reality Navigation System through intra-airway navigation system to guide bronchoscopy in the diagnosis of peripheral pulmonary nodules and explore the factors of diagnosis yield.', 'detailedDescription': 'This is a single-arm, prospective, Asian multicenter, Real World case Registry study. Recruitment is expected to last up to 12 months, and each subject may be followed up for 12 months at most after surgery which depends on certain factors. The total duration of the study is about 24 months.The research is planned to be carried out at more than 10 sites.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The patients expected to be enrolled in this study is those whose chest CT images show the pulmonary nodules are highly suspected of malignant and scheduled to be diagnosed by bronchoscopy under the guidance of the Augmented Reality Navigation System.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥18;\n2. Chest thin-layer CT show that the peripheral pulmonary nodule (maximum diameter ≤3 cm) is not clearly diagnosed, and planned to be sampled and diagnosed by Augmented Reality Navigation System guided bronchoscopy;\n3. The target nodule is evaluated as being able to be reached via bronchoscope under the guidance of Augmented Reality Navigation System before procedure;\n4. Patients can understand the study and sign informed consent form.\n\nExclusion Criteria:\n\n\\-\n\n1\\. Contraindications for bronchoscopy:\n\n1. Myocardial infarction whithin 1 month.\n2. Active massive hemoptysis.\n3. Coagulation dysfunction.\n4. Pregnancy.\n5. Malignant arrhythmia, severe cardiac insufficiency, extreme systemic failure, etc.\n\n2\\. Severe cardiopulmonary dysfunction and other diseases that may significantly increase the risk of procedure; 3. The situations in which the investigators consider that patients are not suitable for this study.'}, 'identificationModule': {'nctId': 'NCT04740606', 'acronym': 'ANDA', 'briefTitle': 'Airway Navigation Database Asia for Diagnosis of Peripheral Pulmonary Nodules', 'organization': {'class': 'OTHER', 'fullName': 'Guangzhou Institute of Respiratory Disease'}, 'officialTitle': 'A Real World Case Registry Study to Evaluate Augmented Reality Navigation System for Diagnosis of Peripheral Pulmonary Nodules', 'orgStudyIdInfo': {'id': '20201222'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Treatment Group', 'description': 'The patients whose chest CT images show that the pulmonary nodules are highly suspected of malignant and scheduled to be diagnosed by bronchoscopy under the guidance of the Augmented Reality Navigation System.', 'interventionNames': ['Device: Augmented Reality Navigation System']}], 'interventions': [{'name': 'Augmented Reality Navigation System', 'type': 'DEVICE', 'description': 'Investigators will assess the nodules based on the CT images of subjects before procedure. And then, the appropriate intra-airway path planned by the Augmented Reality Navigation System will be selected. The bronchoscopy with intra-airway navigation under the guidance of the Augmented Reality Navigation System will be performed and the following surgical information will be record.', 'armGroupLabels': ['Treatment Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510000', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Guangzhou Institute of Respiratory Diseases', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Shiyue Li, MD,PhD', 'role': 'CONTACT', 'email': 'lishiyue@188.com', 'phone': '8620-83062896'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Guangzhou Institute of Respiratory Disease', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hong Kong Sanatorium & Hospital', 'class': 'INDUSTRY'}, {'name': 'Shanghai Chest Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'ShiYue Li', 'investigatorAffiliation': 'Guangzhou Institute of Respiratory Disease'}}}}