Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2025-12-27 @ 12:48 PM
Study NCT ID:
NCT05214560
Status:
COMPLETED
Last Update Posted:
2024-08-19
First Post:
2022-01-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Prospective Clinical Evaluation of BD Spinal Needles
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'gloria.viti@bd.com', 'phone': '00393452237718', 'title': 'Clinical Project Manager', 'organization': 'Becton, Dickinson and Company'}, 'certainAgreement': {'otherDetails': 'PI submits to Sponsor for review a draft 90 days prior to submission of thedraft for publication.Draft shall not divulge any confidential info.Sponsor hasthe right to:review and make comments on any proposed publication; withholdthe use of its name in connection with publication;make any results from thestudy known to its customers and governmental agencies prior topublication.The first publication of the study results shall be made inconjunction with the results from the other PIs.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From the BD Spina needle insertion up to 7 days post procedure', 'description': 'An AE is defined as any untoward medicaloccurrence, unintended disease or injury,or untoward clinical signs (includingabnormal laboratory findings) in subjects,users or other persons, whether or notrelated to the investigational medicaldevice.\n\nAn adverse device effect is defined asany adverse event that is considered tobe related to the use of an investigationalmedical device.', 'eventGroups': [{'id': 'EG000', 'title': 'All Participants', 'description': 'Participants who require a BD Spinal needle as part of their routine medical care.\n\nSpinal needle: Insertion of a spinal needle to perform the neuraxial procedure according to the clinical practice.', 'otherNumAtRisk': 144, 'deathsNumAtRisk': 144, 'otherNumAffected': 17, 'seriousNumAtRisk': 144, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Procedural failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Injection site irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Post lumbar puncture syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Puncture site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Paresthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 144, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Primary Safety: Incidence of Post-dural Puncture Headache (PDPH).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Participants who require a BD Spinal needle as part of their routine medical care.\n\nSpinal needle: Insertion of a spinal needle to perform the neuraxial procedure according to the clinical practice.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.8', 'groupId': 'OG000', 'lowerLimit': '0.8', 'upperLimit': '7.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From insertion up to 7 days post procedure', 'description': 'Percentage of participants with a diagnosis of PDPH in the 7 days following the anesthesia procedure.', 'unitOfMeasure': '% of subjects with a PDPH', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Out of 144 participants who received a neuraxial procedure, a total of 142 participants received a successful placement of the study device and were included in the safety set, used for the primary safety calculation.'}, {'type': 'PRIMARY', 'title': 'Primary Performance: Incidence of Successful Needle Placement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Participants who require a BD Spinal needle as part of their routine medical care.\n\nSpinal needle: Insertion of a spinal needle to perform the neuraxial procedure according to the clinical practice.'}], 'classes': [{'categories': [{'measurements': [{'value': '98.6', 'groupId': 'OG000', 'lowerLimit': '95.1', 'upperLimit': '99.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During the insertion procedure', 'description': 'Successful needle placement in the subarachnoid space defined as the appearance of cerebrospinal fluid from the spinal needle hub.', 'unitOfMeasure': '% of successful needle placement', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '160 subjects signed informed consent. As 1 subject was screening failure, and for other 15 subjects a study procedure was not attempted, the study device was attempted to be placed in 144 subjects: evaluable set, used for primary performance calculation.The study device could not be placed successfully in 1 subject due to pronounced left convex scoliosis and 1 subject with successful placement was not treated via the study device.142 subjects successfully received a placement of the study device'}, {'type': 'SECONDARY', 'title': 'Secondary Safety:Incidence of Any Needle or Procedure-related Spinal/Epidural Hematoma.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Participants who require a BD Spinal needle as part of their routine medical care.\n\nSpinal needle: Insertion of a spinal needle to perform the neuraxial procedure according to the clinical practice.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '2.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From insertion up to 7 days post procedure', 'description': 'Incidence of device/procedure-related adverse events including the incidence of any spinal/epidural hematoma.', 'unitOfMeasure': '% of subject with a spinal hematoma', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '160 subjects signed informed consent. As 1 subject was screening failure, and for the other 15 subjects a study procedure was not attempted, the study device was attempted to be placed in 144 subjects that constitutes the evaluable set used for secondary safety calculation.'}, {'type': 'SECONDARY', 'title': 'Secondary Safety: Incidence of Any Needle or Procedure-related Nerve Damage (Pain or Weakness Lower Extremities).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Participants who require a BD Spinal needle as part of their routine medical care.\n\nSpinal needle: Insertion of a spinal needle to perform the neuraxial procedure according to the clinical practice.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '2.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From insertion up to 7 days post procedure', 'description': 'Incidence of any device or procedure-related adverse events, including the incidence of any nerve damage (pain or weakness lower extremities).', 'unitOfMeasure': '% of subject with a nerve damage', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '160 subjects signed informed consent. As 1 subject was screening failure, and for the other 15 subjects a study procedure was not attempted, the study device was attempted to be placed in 144 subjects that constitutes the evaluable set used for secondary safety calculation.'}, {'type': 'SECONDARY', 'title': 'Secondary Safety: Incidence of Any Needle or Procedure-related Infection (Meningitis, Spinal Abscess)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Participants who require a BD Spinal needle as part of their routine medical care.\n\nSpinal needle: Insertion of a spinal needle to perform the neuraxial procedure according to the clinical practice.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '2.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From insertion up to 7 days post procedure', 'description': 'Incidence of device/procedure-related adverse events including the incidence of any infection (meningitis, spinal abscess)', 'unitOfMeasure': '% of subject with an infection', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '160 subjects signed informed consent. As 1 subject was screening failure, and for the other 15 subjects a study procedure was not attempted, the study device was attempted to be placed in 144 subjects that constitutes the evaluable set used for secondary safety calculation.'}, {'type': 'SECONDARY', 'title': 'Secondary Safety: Incidence of Any Needle or Procedure-related Pain, Skin Redness, Irritation at or Near the Skin Puncture Site.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Participants who require a BD Spinal needle as part of their routine medical care.\n\nSpinal needle: Insertion of a spinal needle to perform the neuraxial procedure according to the clinical practice.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.4', 'groupId': 'OG000', 'lowerLimit': '0.2', 'upperLimit': '4.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From insertion up to 7 days post procedure', 'description': 'Incidence of device/procedure-related adverse events including the incidence of any pain, skin redness, irritation at or near the skin puncture site.', 'unitOfMeasure': '% subjects with pain/readness/irritation', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '160 subjects signed informed consent. As 1 subject was screening failure, and for the other 15 subjects a study procedure was not attempted, the study device was attempted to be placed in 144 subjects that constitutes the evaluable set used for secondary safety calculation.'}, {'type': 'SECONDARY', 'title': 'Secondary Safety: Incidence of Any Needle or Procedure-related Backache.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Participants who require a BD Spinal needle as part of their routine medical care.\n\nSpinal needle: Insertion of a spinal needle to perform the neuraxial procedure according to the clinical practice.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.7', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '3.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From insertion up to 7 days post procedure', 'description': 'Incidence of device/procedure-related adverse events including the incidence of backache.', 'unitOfMeasure': '% of subjects with backache', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '160 subjects signed informed consent. As 1 subject was screening failure, and for the other 15 subjects a study procedure was not attempted, the study device was attempted to be placed in 144 subjects that constitutes the evaluable set used for secondary safety calculation.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Spinal Needle Placement Details - Ease of Use Survey Determined by a Composite Score of BD Spinal Needle and Related Stylet Performance Based on Post-insertion Survey.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Participants who require a BD Spinal needle as part of their routine medical care.\n\nSpinal needle: Insertion of a spinal needle to perform the neuraxial procedure according to the clinical practice.'}], 'classes': [{'title': 'BD Spinal Needle insertion was easy or very easy', 'categories': [{'measurements': [{'value': '135', 'groupId': 'OG000'}]}]}, {'title': 'BD Spinal Needle withdrawal after placement was easy or very easy', 'categories': [{'measurements': [{'value': '143', 'groupId': 'OG000'}]}]}, {'title': 'PIs were agree with "stylet helped to determine the direction of spinal needle tip"', 'categories': [{'measurements': [{'value': '131', 'groupId': 'OG000'}]}]}, {'title': 'PIs were agree or strongly agree with "stylet functioned properly during spinal needle placement".', 'categories': [{'measurements': [{'value': '143', 'groupId': 'OG000'}]}]}, {'title': 'Ease of BD Stylet removal from the spinal needle after placement was easy or very easy', 'categories': [{'measurements': [{'value': '142', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'After spinal needle placement', 'description': 'After the neuraxial procedure data was recorded, the physician investigator completed a short survey to assess the performance of the BD devices used in the procedure.\n\nThe ease-of-use survey was conducted among physician investigator to obtain information on BD spinal needle and related stylet performance.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '160 subjects signed informed consent. As 1 subject was screening failure, and for the other 15 subjects a study procedure was not attempted, the study device was attempted to be placed in 144 subjects that constitutes the evaluable set used for this specific measure. 143 is the overall number of subjects analyzed because 1 physician did not complete the survey.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Spinal Needle Placement Details - Ease of Use Survey Determined by a Composite Score of BD Spinal Introducer Performance Based on Post-insertion Survey.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Participants who require a BD Spinal needle as part of their routine medical care.\n\nSpinal needle: Insertion of a spinal needle to perform the neuraxial procedure according to the clinical practice.'}], 'classes': [{'title': 'Use of the BD Introducer was easy or very easy', 'categories': [{'measurements': [{'value': '104', 'groupId': 'OG000'}]}]}, {'title': 'PIs were agree with "introducer facilitated placement of spinal needle"', 'categories': [{'measurements': [{'value': '103', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'After spinal needle placement', 'description': 'After the neuraxial procedure data was recorded, the physician investigator completed a short survey to assess the performance of the BD devices used in the procedure.\n\nWhen the BD ancillary devices (e.g., spinal introducer) were used, the ease-of-use survey was conducted among physician investigator to obtain information on their performance.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Considering that the Spinal Introducer is an optional aid to perform the spinal procedure, 105 Introducers have been used by physicians to perform the study procedure, but only for 104 of 105 subjects for which the BD introducer has been used, the investigators completed the questionnaire and answered the respective question.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Spinal Needle Placement Details - Ease of Use Survey Determined by a Composite Score of BD Syringe Performance Based on Post-insertion Survey.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Participants who require a BD Spinal needle as part of their routine medical care.\n\nSpinal needle: Insertion of a spinal needle to perform the neuraxial procedure according to the clinical practice.'}], 'classes': [{'title': 'Reading BD Syringe graduations when preparing the dose for spinal injection was very easy', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}]}]}, {'title': 'Securely connecting between the BD Syringe and the BD Spinal Needle hub was easy or very easy', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}]}]}, {'title': 'Disconnecting the syringe from the spinal needle after injection was very easy', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'After spinal needle placement', 'description': 'After the neuraxial procedure data was recorded, the physician investigator completed a short survey to assess the performance of the BD devices used in the procedure.\n\nWhen the BD ancillary devices (e.g., BD syringe) were used, the ease-of-use survey was conducted among physician investigator to obtain information on their performance.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Considering that this study is an observational study in which the physicians performed the spinal procedure according to their clinical practice and hence, they could choose any ancillary devices to achieve the study procedure, 35 BD syringes have been used by physicians to perform the study procedure, and the investigators completed the questionnaire and answered the respective question.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'All Participants', 'description': 'Participants who require a BD Spinal needle as part of their routine medical care.\n\nSpinal needle: Insertion of a spinal needle to perform the neuraxial procedure according to the clinical practice.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '160'}]}, {'type': 'Enrolled Set', 'achievements': [{'comment': 'Participants who signed the informed consent', 'groupId': 'FG000', 'numSubjects': '160'}]}, {'type': 'Evaluable Set', 'achievements': [{'comment': 'Participants who underwent a neuraxial procedure, regardless of success', 'groupId': 'FG000', 'numSubjects': '144'}]}, {'type': 'Safety Set', 'achievements': [{'comment': 'Participants who successfully received a placement of the study device.', 'groupId': 'FG000', 'numSubjects': '142'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '142'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}]}], 'dropWithdraws': [{'type': 'Screening Failure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'General anesthesia at the request of the surgeon', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Study physician not available for the anesthesia', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Anesthesia rejected by the patient on the day of surgery', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Device not listed in the study was used for the procedure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Surgery not performed', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}]}], 'recruitmentDetails': 'The study was conducted at 6 sites in 5 European countries. The first participant was enrolled on February 14, 2022 and the last participant had the last study visit on July 22,2022.', 'preAssignmentDetails': 'The choice of the specific BD Spinal Needle type, size, and length required for an individual participant was left to the discretion of the clinician. In this post market study, 160 participants, who were to receive a neuraxial procedures with a BD Spinal Needle as per routine clinical practice, were observed through 7-days post procedure to assess for adverse events/complications.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Participants', 'description': 'Participants who require a BD Spinal needle as part of their routine medical care.\n\nSpinal needle: Insertion of a spinal needle to perform the neuraxial procedure according to the clinical practice.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '55.5', 'spread': '18.01', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '52', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '92', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '143', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Austria', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}, {'title': 'Finland', 'categories': [{'measurements': [{'value': '35', 'groupId': 'BG000'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '73', 'groupId': 'BG000'}]}]}, {'title': 'Spain', 'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Body Max Index', 'classes': [{'categories': [{'measurements': [{'value': '27.51', 'spread': '4.934', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Primary diagnosis for intervention', 'classes': [{'categories': [{'title': 'Surgery of lower extremities', 'measurements': [{'value': '65', 'groupId': 'BG000'}]}, {'title': 'Surgery of lower abdomen', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}, {'title': 'Surgery of perineum', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Surgery of hips and pelvis', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': 'Obstetric', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Other', 'measurements': [{'value': '47', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Reason for neuraxial procedure', 'classes': [{'title': 'Reason for neuraxial procedure:anesthesia', 'categories': [{'measurements': [{'value': '144', 'groupId': 'BG000'}]}]}, {'title': 'Reason for neuraxial procedure:analgesia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': 'Reason for neuraxial procedure: other', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'American Society of Anesthesiologists (ASA) physical status (PS) classification', 'classes': [{'categories': [{'title': 'ASA PS Classification I', 'measurements': [{'value': '39', 'groupId': 'BG000'}]}, {'title': 'ASA PS Classification II', 'measurements': [{'value': '82', 'groupId': 'BG000'}]}, {'title': 'ASA PS Classification III', 'measurements': [{'value': '23', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'ASA I = A normal healthy patient ASA II = A patient with mild systemic disease ASA III = A patient with severe systemic disease ASA IV = A patient with severe systemic disease that is a constant threat to life', 'unitOfMeasure': 'Participants'}, {'title': 'Spinal needle placement details- Participant position during spinal needle procedure', 'classes': [{'categories': [{'title': 'Lateral position', 'measurements': [{'value': '39', 'groupId': 'BG000'}]}, {'title': 'Sitting position', 'measurements': [{'value': '105', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Spinal needle placement details - Aseptic technique', 'classes': [{'categories': [{'title': 'Aseptic technique = Chlorhexidine', 'measurements': [{'value': '26', 'groupId': 'BG000'}]}, {'title': 'Aseptic technique = Betadine', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'Aseptic technique = Other', 'measurements': [{'value': '112', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Spinal needle placement details - Local anesthesia', 'classes': [{'categories': [{'title': 'Local anesthesia = Lidocaine 1%', 'measurements': [{'value': '105', 'groupId': 'BG000'}]}, {'title': 'Local anesthesia = Lidocaine 2%', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Local anesthesia = Other', 'measurements': [{'value': '34', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Spinal needle placement details - Lumbar interspace', 'classes': [{'categories': [{'title': 'L2-L3', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': 'L3-L4', 'measurements': [{'value': '104', 'groupId': 'BG000'}]}, {'title': 'L4-L5', 'measurements': [{'value': '27', 'groupId': 'BG000'}]}, {'title': 'Other', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Lumbar interspace refers to last try with the spinal needle to achieve the spinal procedure.', 'unitOfMeasure': 'Participants'}, {'title': 'Spinal needle placement details - Number of Puncture attempts', 'classes': [{'categories': [{'title': 'Number of Puncture attempts = 1', 'measurements': [{'value': '136', 'groupId': 'BG000'}]}, {'title': 'Number of Puncture attempts = 2', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Number of Puncture attempts = 3', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Number of Puncture attempts = 4', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Number of puncture attempts is the number of different needles attempted to achieve the spinal procedure.', 'unitOfMeasure': 'Participants'}, {'title': 'Spinal needle placement details - Number of Interspace levels attempts', 'classes': [{'categories': [{'title': 'Number of Interspace levels attempts = 1', 'measurements': [{'value': '132', 'groupId': 'BG000'}]}, {'title': 'Number of Interspace levels attempts = 2', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': 'Number of Interspace levels attempts = 3', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'The number of interspace levels attempts refers to the number of different lumbar interspace.', 'unitOfMeasure': 'Participants'}, {'title': 'Spinal needle placement details - Paresthesia verbalized by participant', 'classes': [{'categories': [{'title': 'Paresthesia not verbalized by participant', 'measurements': [{'value': '138', 'groupId': 'BG000'}]}, {'title': 'Paresthesia verbalized by participant', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Spinal needle placement details - Spontaneous appearance of CSF emerging from the needle hub', 'classes': [{'categories': [{'title': 'Spontaneous appearance of Cerebrospinal Fluid (CSF) emerging from the needle hub', 'measurements': [{'value': '142', 'groupId': 'BG000'}]}, {'title': 'No Spontaneous appearance of Cerebrospinal Fluid (CSF) emerging from the needle hub', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Number of participants with a successful needle placement in the subarachnoid space defined as the appearance of cerebrospinal fluid (CSF) from the spinal needle hub', 'unitOfMeasure': 'Participants'}, {'title': 'Spinal needle placement details - BD Spinal needle type', 'classes': [{'categories': [{'title': 'BD Spinal Quincke needle 22Gx90mm', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'BD Spinal Quincke needle 27Gx90mm', 'measurements': [{'value': '34', 'groupId': 'BG000'}]}, {'title': 'BD Spinal Whitacre needle 25Gx103mm plus BD Introducer 20Gx32mm', 'measurements': [{'value': '19', 'groupId': 'BG000'}]}, {'title': 'BD Spinal Whitacre needle 25Gx90mm plus BD Introducer 20Gx32mm', 'measurements': [{'value': '22', 'groupId': 'BG000'}]}, {'title': 'BD Spinal Whitacre needle 27Gx103mm plus BD Introducer 22Gx32mm', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'BD Spinal Whitacre needle 27Gx90mm plus BD Introducer 22Gx32mm', 'measurements': [{'value': '63', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Spinal needle placement details - BD Syringes', 'classes': [{'categories': [{'title': 'BD Syringe size 5mL used', 'measurements': [{'value': '34', 'groupId': 'BG000'}]}, {'title': 'BD Syringe size 10mL used', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'No BD Syringe used', 'measurements': [{'value': '109', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': '160 subjects signed informed consent (Enrolled Set). 1 subject was screening failure due to "Previous spine surgery at level involved in the study procedure" and 144 subjects underwent a neuraxial procedure, regardless of success (Evaluable Set). The Evaluable set has been considered for the baseline analysis population.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-04-27', 'size': 396114, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-07-24T13:34', 'hasProtocol': True}, {'date': '2022-09-28', 'size': 529952, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-07-24T13:34', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 160}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-02-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2022-07-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-22', 'studyFirstSubmitDate': '2022-01-12', 'resultsFirstSubmitDate': '2023-07-27', 'studyFirstSubmitQcDate': '2022-01-12', 'lastUpdatePostDateStruct': {'date': '2024-08-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-03-22', 'studyFirstPostDateStruct': {'date': '2022-01-28', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-08-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Spinal Needle Placement Details - Ease of Use Survey Determined by a Composite Score of BD Spinal Needle and Related Stylet Performance Based on Post-insertion Survey.', 'timeFrame': 'After spinal needle placement', 'description': 'After the neuraxial procedure data was recorded, the physician investigator completed a short survey to assess the performance of the BD devices used in the procedure.\n\nThe ease-of-use survey was conducted among physician investigator to obtain information on BD spinal needle and related stylet performance.'}, {'measure': 'Spinal Needle Placement Details - Ease of Use Survey Determined by a Composite Score of BD Spinal Introducer Performance Based on Post-insertion Survey.', 'timeFrame': 'After spinal needle placement', 'description': 'After the neuraxial procedure data was recorded, the physician investigator completed a short survey to assess the performance of the BD devices used in the procedure.\n\nWhen the BD ancillary devices (e.g., spinal introducer) were used, the ease-of-use survey was conducted among physician investigator to obtain information on their performance.'}, {'measure': 'Spinal Needle Placement Details - Ease of Use Survey Determined by a Composite Score of BD Syringe Performance Based on Post-insertion Survey.', 'timeFrame': 'After spinal needle placement', 'description': 'After the neuraxial procedure data was recorded, the physician investigator completed a short survey to assess the performance of the BD devices used in the procedure.\n\nWhen the BD ancillary devices (e.g., BD syringe) were used, the ease-of-use survey was conducted among physician investigator to obtain information on their performance.'}], 'primaryOutcomes': [{'measure': 'Primary Safety: Incidence of Post-dural Puncture Headache (PDPH).', 'timeFrame': 'From insertion up to 7 days post procedure', 'description': 'Percentage of participants with a diagnosis of PDPH in the 7 days following the anesthesia procedure.'}, {'measure': 'Primary Performance: Incidence of Successful Needle Placement', 'timeFrame': 'During the insertion procedure', 'description': 'Successful needle placement in the subarachnoid space defined as the appearance of cerebrospinal fluid from the spinal needle hub.'}], 'secondaryOutcomes': [{'measure': 'Secondary Safety:Incidence of Any Needle or Procedure-related Spinal/Epidural Hematoma.', 'timeFrame': 'From insertion up to 7 days post procedure', 'description': 'Incidence of device/procedure-related adverse events including the incidence of any spinal/epidural hematoma.'}, {'measure': 'Secondary Safety: Incidence of Any Needle or Procedure-related Nerve Damage (Pain or Weakness Lower Extremities).', 'timeFrame': 'From insertion up to 7 days post procedure', 'description': 'Incidence of any device or procedure-related adverse events, including the incidence of any nerve damage (pain or weakness lower extremities).'}, {'measure': 'Secondary Safety: Incidence of Any Needle or Procedure-related Infection (Meningitis, Spinal Abscess)', 'timeFrame': 'From insertion up to 7 days post procedure', 'description': 'Incidence of device/procedure-related adverse events including the incidence of any infection (meningitis, spinal abscess)'}, {'measure': 'Secondary Safety: Incidence of Any Needle or Procedure-related Pain, Skin Redness, Irritation at or Near the Skin Puncture Site.', 'timeFrame': 'From insertion up to 7 days post procedure', 'description': 'Incidence of device/procedure-related adverse events including the incidence of any pain, skin redness, irritation at or near the skin puncture site.'}, {'measure': 'Secondary Safety: Incidence of Any Needle or Procedure-related Backache.', 'timeFrame': 'From insertion up to 7 days post procedure', 'description': 'Incidence of device/procedure-related adverse events including the incidence of backache.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Analgesia', 'Anesthesia']}, 'descriptionModule': {'briefSummary': 'Post-market, observational study to assess the real-world safety and efficacy of BD Spinal Needles used in an on-market fashion.', 'detailedDescription': "Single-arm, post-market, observational, prospective study of participants who will receive neuraxial procedures with a BD Spinal Needle as part of their routine medical care.\n\nPatients will be followed from BD Spinal needle insertion up to 7 days after the insertion according to the routine medical care and site policy.\n\nData collected will be gathered from the patient's medical charts."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Any participants who require a spinal needle device as part of their routine medical care.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Any patient, regardless of age or gender, for which the investigator has decided that a neuraxial procedure must be performed utilizing BD Spinal Needles as part of their routine medical care\n* Expected to be available for observation through the study period (7-days post procedure)\n* Provision of signed and dated informed consent form (Note: Consent of guardian or parent may be required for patients under the age of 18 years; participant assent may be required as well.)\n\nExclusion Criteria:\n\n* Undergoing emergency surgery\n* Coagulopathy or bleeding disorder for which regional anesthesia poses an increased risk\n* History of neurological impairment or disease of the trunk or lower extremities.\n* Infection at or near the site of needle insertion\n* Previous spine surgery at the level involved in the study procedure'}, 'identificationModule': {'nctId': 'NCT05214560', 'briefTitle': 'Prospective Clinical Evaluation of BD Spinal Needles', 'organization': {'class': 'INDUSTRY', 'fullName': 'Becton, Dickinson and Company'}, 'officialTitle': 'Prospective Clinical Evaluation of BD Spinal Needles', 'orgStudyIdInfo': {'id': 'MDS-20EPSPEU001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'All participants', 'description': 'Participants who require a BD Spinal needle', 'interventionNames': ['Device: Spinal needle']}], 'interventions': [{'name': 'Spinal needle', 'type': 'DEVICE', 'description': 'Insertion of a spinal needle to perform the neuraxial procedure.', 'armGroupLabels': ['All participants']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Vienna', 'country': 'Austria', 'facility': 'Medizinische Universität Wien', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '60220', 'city': 'Seinäjoki', 'country': 'Finland', 'facility': 'Sejnjoen Central Hospital', 'geoPoint': {'lat': 62.79446, 'lon': 22.82822}}, {'zip': '12203', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Charité Campus Benjamin Franklin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '04103', 'city': 'Leipzig', 'country': 'Germany', 'facility': 'Universitätsklinikum Leipzig', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}, {'zip': '28223', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario Quirónsalud Madrid', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '8008', 'city': 'Zurich', 'country': 'Switzerland', 'facility': 'Schulthess Klinik, Zürich', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'overallOfficials': [{'name': 'Klaus Hoerauf, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Becton, Dickinson and Company'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Becton, Dickinson and Company', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Cromsource', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}