Ignite Creation Date:
2025-12-24 @ 3:52 PM
Ignite Modification Date:
2026-01-03 @ 6:39 PM
Study NCT ID:
NCT02464592
Status:
COMPLETED
Last Update Posted:
2017-09-29
First Post:
2015-05-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Diagnostic Yield and Safety of Transbronchial Lung Biopsy Using Cryoprobes Versus Conventional Forceps. A Multicenter Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017563', 'term': 'Lung Diseases, Interstitial'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2017-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-09-27', 'studyFirstSubmitDate': '2015-05-06', 'studyFirstSubmitQcDate': '2015-06-03', 'lastUpdatePostDateStruct': {'date': '2017-09-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-06-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnostic yield of transbronchial lung biopsy (TBLB)', 'timeFrame': '24 months', 'description': 'Comparing those TBLB obtained by cryoprobes versus conventional forceps (number of diagnosis with each technique).'}], 'secondaryOutcomes': [{'measure': 'Histological quality of samples as defined the presence of alveolar units in each sample. Composite measure.', 'timeFrame': '24 months', 'description': 'The quality of samples are defined by the size, presence of artifacts and presence of alveolar units in each sample.'}, {'measure': 'Safety related to the procedure of the TBLB obtained by cryoprobe compared with conventional forceps assessed by chest radiography.', 'timeFrame': '24 months', 'description': 'Chest radiography after TBLB.'}, {'measure': 'Safety related to the procedure of the TBLB obtained by cryoprobe compared with conventional forceps assessed by control of bleeding.', 'timeFrame': '24 months', 'description': 'Control of bleeding during procedure.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Cryoprobes', 'Transbronchial lung biopsy', 'Cryobiopsy'], 'conditions': ['Lung Diseases, Interstitial']}, 'referencesModule': {'references': [{'pmid': '24890124', 'type': 'BACKGROUND', 'citation': 'Pajares V, Puzo C, Castillo D, Lerma E, Montero MA, Ramos-Barbon D, Amor-Carro O, Gil de Bernabe A, Franquet T, Plaza V, Hetzel J, Sanchis J, Torrego A. Diagnostic yield of transbronchial cryobiopsy in interstitial lung disease: a randomized trial. Respirology. 2014 Aug;19(6):900-6. doi: 10.1111/resp.12322. Epub 2014 Jun 1.'}, {'pmid': '32956379', 'type': 'DERIVED', 'citation': 'Pajares V, Nunez-Delgado M, Bonet G, Perez-Pallares J, Martinez R, Cubero N, Zabala T, Cordovilla R, Flandes J, Disdier C, Torrego A; MULTICRIO Group researchers. Transbronchial biopsy results according to diffuse interstitial lung disease classification. Cryobiopsy versus forceps: MULTICRIO study. PLoS One. 2020 Sep 21;15(9):e0239114. doi: 10.1371/journal.pone.0239114. eCollection 2020.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the diagnostic yield and safety of transbronchial lung biopsies (TBLB) with cryoprobe versus conventional forceps in patients with diffuse lung disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\>18 years old\n* Patients with diffuse lung disease candidate to study with transbronchial lung biopsy (TBLB).\n* Inform consent signed.\n\nExclusion Criteria:\n\n* FEV1 \\<40% of reference value.\n* Respiratory insufficiency (pO2 \\<60 mmHg or pCO2 \\>45 mmHg).\n* Use of anticoagulant therapy or presence of a coagulation (disorder abnormal platelets counts, international normalized ratio \\> 1.5).\n* Bullous emphysema.\n* Pulmonary arterial hypertension.\n* Hypersensitivity to anaesthetic and sedative drugs (lidocaine, midazolam, propofol, remifentanyl).\n* Psychiatric illness.\n* Comorbidities that could increase the risk of the TBLB.\n* Pregnancy.'}, 'identificationModule': {'nctId': 'NCT02464592', 'briefTitle': 'Diagnostic Yield and Safety of Transbronchial Lung Biopsy Using Cryoprobes Versus Conventional Forceps. A Multicenter Study', 'organization': {'class': 'OTHER', 'fullName': "Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau"}, 'officialTitle': 'Diagnostic Yield and Safety of Transbronchial Lung Biopsy Using Cryoprobes Versus Conventional Forceps. A Multicenter Study', 'orgStudyIdInfo': {'id': 'IIBSP-CRI-2014-05'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Biopsy with Cryoprobes', 'description': 'Transbronchial lung biopsy with a cryoprobe.', 'interventionNames': ['Procedure: Transbronchial lung biopsy.']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Biopsy with Conventional Forceps', 'description': 'Transbronchial lung biopsy with conventional forceps.', 'interventionNames': ['Procedure: Transbronchial lung biopsy.']}], 'interventions': [{'name': 'Transbronchial lung biopsy.', 'type': 'PROCEDURE', 'description': 'Transbronchial lung biopsy with cryoprobe and with conventional forceps.', 'armGroupLabels': ['Biopsy with Conventional Forceps', 'Biopsy with Cryoprobes']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08025', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital de la Santa Creu i Sant Pau', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'overallOfficials': [{'name': 'Virginia Pajares, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau", 'class': 'OTHER'}, 'collaborators': [{'name': 'Hospital Universitario La Fe', 'class': 'OTHER'}, {'name': 'Germans Trias i Pujol Hospital', 'class': 'OTHER'}, {'name': 'Hospital General Universitario Santa Lucía', 'class': 'OTHER'}, {'name': 'Hospital Universitari de Bellvitge', 'class': 'OTHER'}, {'name': 'Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz', 'class': 'OTHER'}, {'name': 'Complejo Hospitalario Universitario de Vigo', 'class': 'OTHER'}, {'name': 'University of Salamanca', 'class': 'OTHER'}, {'name': 'Hospital Universitario de Valladolid', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}