Ignite Creation Date:
2025-12-24 @ 11:37 PM
Ignite Modification Date:
2026-01-22 @ 11:41 AM
Study NCT ID:
NCT00643656
Status:
COMPLETED
Last Update Posted:
2025-03-13
First Post:
2008-03-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of 50% Nitrous Oxide / 50% Oxygen Premix During Liver Biopsy of Focal Lesion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D010100', 'term': 'Oxygen'}, {'id': 'D009584', 'term': 'Nitrogen'}], 'ancestors': [{'id': 'D018011', 'term': 'Chalcogens'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D005740', 'term': 'Gases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 94}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-11', 'studyFirstSubmitDate': '2008-03-19', 'studyFirstSubmitQcDate': '2008-03-20', 'lastUpdatePostDateStruct': {'date': '2025-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-03-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain measurement by using Visual Analog Scale (VAS)', 'timeFrame': 'At the end of the liver biospy'}], 'secondaryOutcomes': [{'measure': "Patient's acceptance and doctor's satisfaction", 'timeFrame': 'At the end of the liver biopsy'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Liver biopsy'], 'conditions': ['Liver Biopsy']}, 'referencesModule': {'references': [{'pmid': '21511500', 'type': 'BACKGROUND', 'citation': "Meskine N, Vullierme MP, Zappa M, d'Assignies G, Sibert A, Vilgrain V. Evaluation of analgesic effect of equimolar mixture of oxygen and nitrous oxide inhalation during percutaneous biopsy of focal liver lesions: a double-blind randomized study. Acad Radiol. 2011 Jul;18(7):816-21. doi: 10.1016/j.acra.2011.01.025. Epub 2011 Apr 20."}], 'seeAlsoLinks': [{'url': 'https://pubmed.ncbi.nlm.nih.gov/21511500/', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'A 50% nitrous oxide / 50% oxygen premix is administrated to the patient during the realization of liver biopsy in order to relax him and to reduce his pain during this painful medical treatment. This single investigator centre and national clinical trial is done blindly : half of patients will receive 50% nitrous oxide / 50% oxygen premix and half of them a placebo gas (mixture of 50% oxygen and 50% nitrogen). 94 patients will be included in this clinical protocol.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patient requiring a liver biopsy of focal lesion\n* Age upper than 18 years\n* OMS : 0 to 3\n* patient consent form signed\n\nExclusion Criteria:\n\n* patient unable to use Visual Analog Scale (VAS)\n* OMS upper than 3\n* coagulation disorder\n* contraindication linked to the experimental product\n* patient already included in another clinical trial uncompatible with this trial'}, 'identificationModule': {'nctId': 'NCT00643656', 'briefTitle': 'Use of 50% Nitrous Oxide / 50% Oxygen Premix During Liver Biopsy of Focal Lesion', 'organization': {'class': 'INDUSTRY', 'fullName': 'Air Liquide Santé International'}, 'officialTitle': 'Study of the Efficiency of Kalinox 170 Bar During Liver Biospy of Focal Lesion', 'orgStudyIdInfo': {'id': 'EudraCT : 2006-004203-19'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'description': 'Mixture of 50% nitrous oxide and 50% oxygen', 'interventionNames': ['Drug: Kalinox 170 bar']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'B', 'description': 'Mixture of 50% oxygen and 50% nitrogen', 'interventionNames': ['Drug: Mix of 50% oxygen and 50% nitrogen']}], 'interventions': [{'name': 'Kalinox 170 bar', 'type': 'DRUG', 'description': 'Flow of gas administrated to the patient between 4 and 15 litre/min and less than 1 hour', 'armGroupLabels': ['A']}, {'name': 'Mix of 50% oxygen and 50% nitrogen', 'type': 'DRUG', 'description': 'Flow of gas administrated to the patient between 4 and 15 litre/min and less than 1 hour', 'armGroupLabels': ['B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92118', 'city': 'Clichy', 'country': 'France', 'facility': 'Beaujon hospital', 'geoPoint': {'lat': 48.90018, 'lon': 2.30952}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Air Liquide Santé International', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}