Ignite Creation Date:
2025-12-26 @ 11:13 PM
Ignite Modification Date:
2026-03-17 @ 10:12 PM
Study NCT ID:
NCT02602912
Status:
COMPLETED
Last Update Posted:
2019-02-27
First Post:
2015-11-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Identification of Spine Structures by Using BIP-Needles
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D009339', 'term': 'Needles'}], 'ancestors': [{'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 69}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2018-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-26', 'studyFirstSubmitDate': '2015-11-09', 'studyFirstSubmitQcDate': '2015-11-10', 'lastUpdatePostDateStruct': {'date': '2019-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-11-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'True positive and false positive detection of cerebrospinal fluid marked in case report form', 'timeFrame': 'During spinal puncture', 'description': 'Measurement device indicates with a sound and visual feedback when needle reaches cerebrospinal fluid (CSF). Physician verifies the location by removing the needle stylet and testing whether CSF flows from the needle, similarly as in traditional process. Detection is true positive if CSF flows from the needle and false positive if not. Even if the device does not detect the spinal fluid, physician performs the CSF test when needed. Physician marks to the case report form whether the device provided detections during the spinal puncture and were the detections true or false detections.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Spinal Puncture']}, 'descriptionModule': {'briefSummary': 'The main purpose of the study is to assess the feasibility and clinical performance of impedance based tissue identification in various spine structures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Voluntary adult patients going through medical operation involving spinal puncture, spinal fluid sampling or intrathecal drug injection.\n\nExclusion Criteria:\n\n* Participation to other clinical study\n* Exclusion criteria are the same as generally for spinal anaesthesia and lumbar punctures. Exclusion criteria includes infection on skin area, systemic anticoagulation, sepsis, anatomical unsuitability and refusal\n* In addition for not giving (or not capable to give) the consent personally for any reason is an absolute exclusion criterion. In practice this means that study is for adult patients only.'}, 'identificationModule': {'nctId': 'NCT02602912', 'briefTitle': 'Identification of Spine Structures by Using BIP-Needles', 'organization': {'class': 'INDUSTRY', 'fullName': 'Injeq Ltd'}, 'officialTitle': 'INJ-SPINE-01 Identification of Spine Structures by Using BIP-Needles', 'orgStudyIdInfo': {'id': 'INJ-SPINE-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Injeq Bioimpedance Probe (BIP) Needle', 'description': 'Injeq Bioimpedance Probe (BIP) Needle is a spinal needle that has bioimpedance measurement capability.', 'interventionNames': ['Device: Injeq Bioimpedance Probe (BIP) Needle']}], 'interventions': [{'name': 'Injeq Bioimpedance Probe (BIP) Needle', 'type': 'DEVICE', 'description': 'Injeq Bioimpedance Probe (BIP) Needle is a spinal needle that has bioimpedance measurement capability. It consists of traditional needle cannulae and removable bioimpedance probe which enables the measurement of bioimpedance. The needle is connected to measurement device and tissue identifying algorithm. Bioimpedance is measured during the operation and the algorithm detects when the needle tip is in contact with cerebrospinal fluid.', 'armGroupLabels': ['Injeq Bioimpedance Probe (BIP) Needle']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'FI- 33521', 'city': 'Tampere', 'country': 'Finland', 'facility': 'Tampere University Hospital', 'geoPoint': {'lat': 61.49911, 'lon': 23.78712}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Injeq Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}