Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2026-03-11 @ 10:38 PM
Study NCT ID:
NCT03321994
Status:
UNKNOWN
Last Update Posted:
2017-10-26
First Post:
2017-10-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CT-guided Needle Guidance Using Stereotaxic Unit, Navigation Versus Conventional Biopsy Technique for the Percutaneous Pulmonary Nodule Biopsy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 106}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2017-11', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2019-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-10-24', 'studyFirstSubmitDate': '2017-10-23', 'studyFirstSubmitQcDate': '2017-10-24', 'lastUpdatePostDateStruct': {'date': '2017-10-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Radiation dose(DLP, mGy·cm)', 'timeFrame': '1 day', 'description': 'DLP(mGy·cm) = CTDIvol x scan length'}, {'measure': 'Occurrence rate of adverse device effect(%)', 'timeFrame': '1 month', 'description': 'Adverse events that are correlated with the needle insertion procedure'}], 'primaryOutcomes': [{'measure': 'Needle guide accuracy(mm)', 'timeFrame': '1 day', 'description': '3D distance between target point and actual needle tip'}], 'secondaryOutcomes': [{'measure': 'Needle guide angle deviation(°)', 'timeFrame': '1 day', 'description': 'The angle deviation between the needle insertion path on the procedure plan and the path of the actually inserted needle'}, {'measure': 'Number of needle readjustments', 'timeFrame': '1 day', 'description': 'Retract the inserted needle and adjust the direction'}, {'measure': 'Number of needle reinsertion', 'timeFrame': '1 day', 'description': 'Needle is completely pulled out and then inserted again'}, {'measure': 'Needle insertion time(min)', 'timeFrame': '1 day', 'description': 'Time from pre-CT scan to the last CT scan before lung biopsy'}, {'measure': 'Procedure time(min)', 'timeFrame': '1 day', 'description': 'Time from pre-CT scan to dressing after lung biopsy'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Percutaneous Pulmonary Nodule Biopsy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to compare the safety and efficacy of CT-guided needle guidance using stereotaxic unit, navigation versus conventional biopsy technique for the patients scheduled to undergo percutaneous pulmonary nodule biopsy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient with localized lesions such as pulmonary nodules on chest x-ray, CT or PET CT\n* Histopathologic examination is necessary if lung lesion is unknown\n* Histologic findings affect the disease stage or treatment plan\n* If the investigator decides to perform a percutaneous lung biopsy because the biopsy or diagnosis through the bronchoscopy is not possible or has low risk-benefit\n* Patient who have consented to contraception during the period of clinical trial participation (one month after the procedure)\n* Patient who voluntarily agree to participate in this clinical trial and are willing to comply with the protocol\n\nExclusion Criteria:\n\n* Patient with pulmonary function insufficiency\n* Patient who has difficulty in self-breathing (e.g, breathing through oxygen breathing apparatus)\n* Patient with Uncontrolled coagulation disorders (INR \\> 1.3 or Blood platelet count \\< 50,000/µl)\n* Patient with allergy to CT contrast agent\n* Patient under 19 years old or over 80 years old\n* Pregnant or lactating\n* Patient with uncontrollable systemic disease (e.g, uncontrolled hypertension, uncontrolled cardiovascular disease, etc.)\n* Patient who currently participating or has participated in other clinical trials within 30 days of the screening date\n* If it is judged inappropriate to participate in this clinical trial under the judgment of the investigator'}, 'identificationModule': {'nctId': 'NCT03321994', 'briefTitle': 'CT-guided Needle Guidance Using Stereotaxic Unit, Navigation Versus Conventional Biopsy Technique for the Percutaneous Pulmonary Nodule Biopsy', 'organization': {'class': 'OTHER', 'fullName': 'Asan Medical Center'}, 'officialTitle': 'A Single-center, Randomized, Active-controlled and Evaluator-blind Investigator-initiated Trial to Evaluate and Compare the Efficacy and Safety of CT-guided Needle Guidance Using Stereotaxic Unit, Navigation Versus Conventional Biopsy Technique for the Patients Scheduled to Undergo Percutaneous Pulmonary Nodule Biopsy', 'orgStudyIdInfo': {'id': 'AS-NPR-03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Stereotaxic unit, navigation', 'interventionNames': ['Device: stereotaxic unit, navigation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional biopsy technique', 'interventionNames': ['Device: conventional biopsy technique']}], 'interventions': [{'name': 'stereotaxic unit, navigation', 'type': 'DEVICE', 'description': 'CT-guided needle guidance using stereotaxic unit, navigation', 'armGroupLabels': ['Stereotaxic unit, navigation']}, {'name': 'conventional biopsy technique', 'type': 'DEVICE', 'description': 'CT-guided needle guidance using conventional biopsy technique', 'armGroupLabels': ['Conventional biopsy technique']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Hyung Jin Won, MD., PhD', 'role': 'CONTACT', 'email': 'hyungjin.won@gmail.com', 'phone': '82-2-3010-4352'}, {'name': 'Sang Young Oh, MD., PhD', 'role': 'CONTACT', 'email': 'ojangsa@gmail.com', 'phone': '82-2-3010-4352'}], 'overallOfficials': [{'name': 'Hyung Jin Won, MD., PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Asan Medical Center, Seoul, Korea'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hyung Jin Won', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Hyung Jin Won', 'investigatorAffiliation': 'Asan Medical Center'}}}}