Ignite Creation Date:
2025-12-24 @ 3:41 PM
Ignite Modification Date:
2026-01-01 @ 5:52 PM
Study NCT ID:
NCT05230992
Status:
COMPLETED
Last Update Posted:
2024-02-14
First Post:
2021-09-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optimization of the Sensitivity of Histological Diagnosis of Pulmonary Nodules
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is a clinical investigation of a CE (Communauté Européenne)-marked medical device that is monocentric, interventional, prospective, comparative, randomized, open-label, with cross-over design.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-11-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-13', 'studyFirstSubmitDate': '2021-09-24', 'studyFirstSubmitQcDate': '2022-01-28', 'lastUpdatePostDateStruct': {'date': '2024-02-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Validity of samples by cryoprobes', 'timeFrame': 'Within 24 hours after intervention', 'description': 'Histological diagnosis from the material collected by cryoprobes and conventional forceps'}], 'secondaryOutcomes': [{'measure': 'Specificity, sensitivity, and predictive values of each technique', 'timeFrame': 'Within 24 hours after intervention', 'description': 'specificity, sensitivity, predictive values'}, {'measure': 'Tolerance and safety of the samples taken', 'timeFrame': '15 Days after intervention', 'description': 'Collection of adverse events for the duration of the study.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Nodule']}, 'referencesModule': {'references': [{'pmid': '26932382', 'type': 'BACKGROUND', 'citation': 'Dhooria S, Sehgal IS, Aggarwal AN, Behera D, Agarwal R. Diagnostic Yield and Safety of Cryoprobe Transbronchial Lung Biopsy in Diffuse Parenchymal Lung Diseases: Systematic Review and Meta-Analysis. Respir Care. 2016 May;61(5):700-12. doi: 10.4187/respcare.04488. Epub 2016 Mar 1.'}, {'pmid': '27055830', 'type': 'BACKGROUND', 'citation': 'Hagmeyer L, Theegarten D, Treml M, Priegnitz C, Randerath W. Validation of transbronchial cryobiopsy in interstitial lung disease - interim analysis of a prospective trial and critical review of the literature. Sarcoidosis Vasc Diffuse Lung Dis. 2016 Mar 29;33(1):2-9.'}, {'pmid': '30725025', 'type': 'BACKGROUND', 'citation': 'Montufar F, Moral LD, Labarca G, Folch E, Majid A, Fernandez-Bussy S. [Transbronchial cryobiopsies and cryotherapy in lung diseases]. Rev Med Chil. 2018 Sep;146(9):1033-1040. doi: 10.4067/s0034-98872018000901033. Spanish.'}, {'pmid': '25998966', 'type': 'BACKGROUND', 'citation': 'Gershman E, Fruchter O, Benjamin F, Nader AR, Rosengarten D, Rusanov V, Fridel L, Kramer MR. Safety of Cryo-Transbronchial Biopsy in Diffuse Lung Diseases: Analysis of Three Hundred Cases. Respiration. 2015;90(1):40-6. doi: 10.1159/000381921. Epub 2015 May 20.'}, {'pmid': '20226474', 'type': 'BACKGROUND', 'citation': 'Schumann C, Hetzel J, Babiak AJ, Merk T, Wibmer T, Moller P, Lepper PM, Hetzel M. Cryoprobe biopsy increases the diagnostic yield in endobronchial tumor lesions. J Thorac Cardiovasc Surg. 2010 Aug;140(2):417-21. doi: 10.1016/j.jtcvs.2009.12.028. Epub 2010 Mar 11.'}, {'pmid': '21852332', 'type': 'BACKGROUND', 'citation': 'Hetzel J, Eberhardt R, Herth FJ, Petermann C, Reichle G, Freitag L, Dobbertin I, Franke KJ, Stanzel F, Beyer T, Moller P, Fritz P, Ott G, Schnabel PA, Kastendieck H, Lang W, Morresi-Hauf AT, Szyrach MN, Muche R, Shah PL, Babiak A, Hetzel M. Cryobiopsy increases the diagnostic yield of endobronchial biopsy: a multicentre trial. Eur Respir J. 2012 Mar;39(3):685-90. doi: 10.1183/09031936.00033011. Epub 2011 Aug 18.'}]}, 'descriptionModule': {'briefSummary': 'In pulmonary oncology, the diagnosis of medium-sized pulmonary nodules (10 to 20 mm), too distal to be reached by standard bronchial fibroscopy but remaining proximal, is difficult.\n\nThere are 2 techniques: transthoracic puncture-biopsy under CT scan, usually performed by radiologists, and distal sampling guided by radial ultrasound mini-probe.\n\nThe limitations of the last technique could be overcome by the use of cryoprobes for sampling, as they would take more tissue by freezing.', 'detailedDescription': 'Concerning the interventional pneumology technique, it is performed in two steps: identification of the mass with the mini ultrasound probe and then distal sampling with a small biopsy forceps. Experience shows that there is a significant difference between the identification of the mass, which is fairly conclusive, and the samples, which are much less productive (60% at best), because it is necessary that :\n\n* that the tumor is endo-bronchial,\n* that the forceps open sufficiently to take samples by back and forth movements\n* but, on the other hand, that the bronchus is not too wide.\n\nThe use of cryoprobes would allow to take more tissue by freezing. The target tissue freezes at the tip of the cryoprobe and can be detached by traction. The longer the freezing time, the more tissue is removed.\n\nVarious studies of endo-bronchial visible tumor diagnosis have compared these 2 sampling techniques (cryoprobe and conventional biopsy forceps). The cryoextraction technique performed by cryoprobes has a superior diagnostic yield (compared to flexible forceps biopsy) due to large biopsies and superior quality of the biopsied tissue (very few crush artifacts or hematomas; the morphological structure remains intact).\n\nIn this context, it seems interesting to compare these 2 techniques but in distal situation, under ultrasound detection with the mini-probes, for tumors not visible in endo-bronchial. The first samples taken in the investigating center by this technique are convincing.\n\nIn the framework of this study, in the same operating time and after ultrasound identification of the tumor, biopsies will be performed by conventional forceps (5 samples) and by cryoprobes (3 samples) on the same site. The sequence of use of one or the other technique will be randomly selected. Thus, each patient is his own control.\n\nThis first pilot study will explore the feasibility, effectiveness and safety of this procedure. Depending on the results of this comparative study, a second study including more patients will validate this procedure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient with a tumor of any location with a draining bronchus (primary lung cancer or lung metastases)\n* Suspected lung nodule(s) with anatomical situation on mid 1/3 CT\n* Presence of at least one lung nodule of sufficient size on CT to allow for at least 8 tissue samples\n* Male or female aged ≥ 18 years\n* Mandatory membership in a health insurance plan\n* Patient who has been informed about the study and has signed the informed consent form\n\nExclusion Criteria:\n\n* Proximal or distal pulmonary nodule(s)\n* Pacemaker patient\n* Pregnant or nursing women\n* Patients under legal protection'}, 'identificationModule': {'nctId': 'NCT05230992', 'acronym': 'CRYOPROBE', 'briefTitle': 'Optimization of the Sensitivity of Histological Diagnosis of Pulmonary Nodules', 'organization': {'class': 'OTHER', 'fullName': 'Elsan'}, 'officialTitle': 'Optimization of the Sensitivity of Histological Diagnosis of Pulmonary Nodules Using Cryoprobes Versus Standard Biopsy Forceps During Distal Sampling Guided by Mini Radial Ultrasound Probes', 'orgStudyIdInfo': {'id': 'CRYOPROBE'}, 'secondaryIdInfos': [{'id': '2021-A01209-32', 'type': 'OTHER', 'domain': 'ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cryoprobes First', 'description': 'Use of cryoprobes and then conventional forceps during the same operating time.', 'interventionNames': ['Device: Cryoprobes First']}, {'type': 'EXPERIMENTAL', 'label': 'Cryoprobes Second', 'description': 'Use of conventional forceps and then cryoprobes during the same operating time.', 'interventionNames': ['Device: Cryoprobes Second']}], 'interventions': [{'name': 'Cryoprobes First', 'type': 'DEVICE', 'description': 'In this experimental group, the Cryoprobe is used in first and the classic biopsy forceps in a second time. This medical device under study is the flexible, single-use Cryoprobe, supplied in sterile condition, 1.1 mm in diameter, 1150 mm long, with extraction tube, 817 mm long (reference 20402-401), or 757 mm long (reference 20402-402) marketed. These cryoprobes are covered by a CE marking. Cryoprobes must be used in conjunction with the Erbecryo®2 device and its accessories.', 'armGroupLabels': ['Cryoprobes First']}, {'name': 'Cryoprobes Second', 'type': 'DEVICE', 'description': 'In this second experimental group, the same medical devices are used but in the other order.', 'armGroupLabels': ['Cryoprobes Second']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44800', 'city': 'Saint-Herblain', 'country': 'France', 'facility': 'Pneumologie Elsan Santé Atlantique', 'geoPoint': {'lat': 47.21154, 'lon': -1.651}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Elsan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}