Ignite Creation Date:
2025-12-25 @ 1:01 AM
Ignite Modification Date:
2025-12-25 @ 11:15 PM
Study NCT ID:
NCT05259293
Status:
COMPLETED
Last Update Posted:
2024-09-19
First Post:
2021-12-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Characteristics of Pneumothorax Associated With Transthoracic Percutaneous Lung Biopsy in Standard of Care
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 243}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-12-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-05', 'studyFirstSubmitDate': '2021-12-07', 'studyFirstSubmitQcDate': '2022-02-18', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Annual incidence rate of pneumothorax related to transthoracic lung biopsy on total number of lung biopsies', 'timeFrame': '3 months'}], 'secondaryOutcomes': [{'measure': 'Annual incidence rate of hospitalisation in patients with pneumothorax related to lung biopsies', 'timeFrame': '3 months'}, {'measure': 'Annual incidence rate of drainage in patients with pneumothorax related to lung biopsies', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['interventional radiology, iatrogenic pneumothorax, transthoracic lung biopsy, pneumothorax rate, pneumothorax characteristics, patient management'], 'conditions': ['Pneumothorax Iatrogenic Postprocedural']}, 'descriptionModule': {'briefSummary': 'The number of lung biopsies has increased steadily in recent years. Pneumothorax is the most common complication of a lung biopsy and can occur during the procedure, immediately after the procedure or within a few hours (delayed pneumothorax). The incidence of pneumothorax in the literature is very different from one study to another: it has been reported to be from 9 to 54% in patients undergoing percutaneous transthoracic needle biopsy. This difference of incidence could be explained by the absence of consensus for the definition of an iatrogenic pneumothorax.\n\nThe characteristics of pneumothorax and the management of patients with iatrogenic pneumothorax will be evaluated in different centres in a retrospective manner. This study will contribute to refining the criteria for defining pneumothorax occurring during lung biopsy and will provide a better understanding of the condition and its management.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients who presented with a pneumothorax following their lung biopsy (see eligibility criteria)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 18 years old and more at the time of the biopsy procedure in year 2020\n* Having had a pneumothorax following their transthoracic percutaneous lung biopsy in year 2020\n\nExclusion Criteria:\n\n* Objection to the use of the data (French sites only)'}, 'identificationModule': {'nctId': 'NCT05259293', 'acronym': 'PNOrate', 'briefTitle': 'Characteristics of Pneumothorax Associated With Transthoracic Percutaneous Lung Biopsy in Standard of Care', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Besancon'}, 'officialTitle': 'Characteristics of Pneumothorax Associated With Transthoracic Percutaneous Lung Biopsy in Standard of Care: a Retrospective Study in 6 Centers', 'orgStudyIdInfo': {'id': '2021/625'}}, 'armsInterventionsModule': {'interventions': [{'name': 'No intervention - retrospective study', 'type': 'OTHER', 'description': 'This is a retrospective study. No intervention.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Besançon', 'country': 'France', 'facility': 'CHU de Besançon', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}, {'city': 'Bordeaux', 'country': 'France', 'facility': 'Institut Bergonié', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'city': 'Tours', 'country': 'France', 'facility': 'CHU de Tours', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}, {'city': 'Villejuif', 'country': 'France', 'facility': 'Institut Gustave Roussy', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}, {'city': 'Dublin', 'country': 'Ireland', 'facility': 'Saint James Hospital', 'geoPoint': {'lat': 53.33306, 'lon': -6.24889}}, {'city': 'Oxford', 'country': 'United Kingdom', 'facility': 'Oxford University Hospitals', 'geoPoint': {'lat': 51.75222, 'lon': -1.25596}}], 'overallOfficials': [{'name': 'Julien BEHR, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU de Besançon'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Besancon', 'class': 'OTHER'}, 'collaborators': [{'name': 'Institut National de la Santé Et de la Recherche Médicale, France', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}