Ignite Creation Date:
2025-12-25 @ 3:04 AM
Ignite Modification Date:
2026-03-03 @ 10:01 PM
Study NCT ID:
NCT01602133
Status:
UNKNOWN
Last Update Posted:
2012-10-25
First Post:
2012-05-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Ultrasound-guided Inserted Peripheral Intravenous Catheter
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 29}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-10', 'completionDateStruct': {'date': '2014-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-10-24', 'studyFirstSubmitDate': '2012-05-17', 'studyFirstSubmitQcDate': '2012-05-17', 'lastUpdatePostDateStruct': {'date': '2012-10-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-05-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'length of use of the catheter measured in number of days', 'timeFrame': 'seven days'}], 'secondaryOutcomes': [{'measure': 'adverse event during the period of use of the catheter', 'timeFrame': 'seven days', 'description': 'extravasation and/or catheter removal before the end of the treatment and/or local complications (bleeding, neurologic trouble, venous thrombosis..)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['venous puncture', 'seldinger technique', 'ultrasound guidance'], 'conditions': ['Venous Puncture']}, 'referencesModule': {'references': [{'pmid': '36507736', 'type': 'DERIVED', 'citation': 'Tada M, Yamada N, Matsumoto T, Takeda C, Furukawa TA, Watanabe N. Ultrasound guidance versus landmark method for peripheral venous cannulation in adults. Cochrane Database Syst Rev. 2022 Dec 12;12(12):CD013434. doi: 10.1002/14651858.CD013434.pub2.'}]}, 'descriptionModule': {'briefSummary': 'Evaluate the safety and efficacy of an an ultrasound-guided inserted peripheral intravenous catheter during a period of seven days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Hospitalized patients with need of an intravenous therapy on peripheral line\n* Unsuccessful attempts at establishing a peripheral intravenous line by nurse\n* Age over 18 YO\n* Written informed consent obtained\n\nExclusion Criteria:\n\n* pregnant woman\n* local contra-indication for venous puncture\n* unconscious patient\n* need of intravenous therapy requiring central line'}, 'identificationModule': {'nctId': 'NCT01602133', 'acronym': 'ECLIPSE', 'briefTitle': 'Assessment of Ultrasound-guided Inserted Peripheral Intravenous Catheter', 'organization': {'class': 'INDUSTRY', 'fullName': 'Prodimed SAS'}, 'officialTitle': 'A Clinical Assessment of an Ultrasound-guided Inserted Peripheral Intravenous Catheter', 'orgStudyIdInfo': {'id': '2011-A01570-41'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'one intervention arm', 'interventionNames': ['Procedure: peripheral venous puncture']}], 'interventions': [{'name': 'peripheral venous puncture', 'type': 'PROCEDURE', 'description': 'Ultrasound imaging of the arm is performed. If a suitable vein is identified, a percutaneous puncture is performed under ultrasound guidance. Then, an intravenous catheter is inserted according Seldinger method.', 'armGroupLabels': ['one intervention arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91 100', 'city': 'Corbeil-Essonnes', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Centre Hospitalier Sud Francilien', 'geoPoint': {'lat': 48.60603, 'lon': 2.48757}}], 'centralContacts': [{'name': 'pascal meyer, MD', 'role': 'CONTACT', 'email': 'pas.meyer@yahoo.fr'}], 'overallOfficials': [{'name': 'Pascal Meyer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Hospitalier Sud Francilien- Corbeil- France'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Prodimed SAS', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}