Ignite Creation Date:
2025-12-24 @ 3:02 PM
Ignite Modification Date:
2026-02-21 @ 8:30 AM
Study NCT ID:
NCT04168359
Status:
COMPLETED
Last Update Posted:
2021-06-22
First Post:
2019-11-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Semi-barbed Suture for Pulmonary Small Nodules Localization
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003074', 'term': 'Solitary Pulmonary Nodule'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DEVICE_FEASIBILITY', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-12-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2021-03-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-20', 'studyFirstSubmitDate': '2019-11-17', 'studyFirstSubmitQcDate': '2019-11-17', 'lastUpdatePostDateStruct': {'date': '2021-06-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Success rate', 'timeFrame': 'half an hour after locating', 'description': 'Successfully located around the small nodules in the lungs, no dislocation occurred'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Suture', 'Nodule, Solitary Pulmonary', 'Video-Assisted Thoracoscopic Surgery']}, 'descriptionModule': {'briefSummary': "Hookwire and microcoil are currently the most widely used localization instruments. Although their success rate is relatively high in preoperative localization attempts, they may lead to consequences that negatively affect patient outcomes, such as pain because of the metal's hardness, localization failure due to wire detachment, and the presence of permanent traces of metal and foreign bodies .\n\nTo overcome these disadvantages, we designed an absorbable semi-barbed suture to localize small intrapulmonary nodules (patent number: ZL201821444387.X).\n\nThe results of the previous animal experiments were satisfactory, and it is now necessary to recruit 10 patients for clinical trials."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. solid nodules with a diameter2cm and distance to visceral pleura 0.5cm；\n2. GGN；\n3. part-solid GGN, with a solid portion1cm and distance to the visceral pleura 1cm；\n4. Patients with nodules at a deep location, who underwent localization to facilitate localization in the resected specimen by a pathologist\n\nExclusion Criteria:\n\n1. The lesion site is not suitable for percutaneous lung puncture;\n2. those who have pneumothorax and pleural effusion;\n3. Poor general condition, severe damage to cardiopulmonary function, cachexia, and inability to tolerate surgery;\n4. Those who refuse surgery;\n5. Those who did not sign the informed consent form.'}, 'identificationModule': {'nctId': 'NCT04168359', 'briefTitle': 'Semi-barbed Suture for Pulmonary Small Nodules Localization', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Aerospace General Hospital'}, 'officialTitle': 'A Clinical Application Study of a CT Guided Small Pulmonary Nodule Puncture and Positioning Device Based on Pre-filled Absorbable Semi-barbed Wire', 'orgStudyIdInfo': {'id': 'JH.2017.0579'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Semi-barbed Sutures Localization Group', 'description': 'Patients with pulmonary nodules requiring CT-guided puncture positioning before thoracoscopic surgery', 'interventionNames': ['Device: absorbable semi-barbed suture']}], 'interventions': [{'name': 'absorbable semi-barbed suture', 'type': 'DEVICE', 'description': 'Positioning the intrapulmonary nodules of patient in this group with a absorbable semi-barbed suture positioning device', 'armGroupLabels': ['Semi-barbed Sutures Localization Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100076', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Beijing aerospace general hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Aerospace General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}