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| Name | Class |
|---|---|
| Cromsource | INDUSTRY |
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Post-market, observational study to assess the real-world safety and efficacy of BD Spinal Needles used in an on-market fashion.
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.
Patients will be followed from BD Spinal needle insertion up to 7 days after the insertion according to the routine medical care and site policy.
Data collected will be gathered from the patient's medical charts.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All participants | Participants who require a BD Spinal needle |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spinal needle | Device | Insertion of a spinal needle to perform the neuraxial procedure. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Safety: Incidence of Post-dural Puncture Headache (PDPH). | Percentage of participants with a diagnosis of PDPH in the 7 days following the anesthesia procedure. | From insertion up to 7 days post procedure |
| Primary Performance: Incidence of Successful Needle Placement | Successful needle placement in the subarachnoid space defined as the appearance of cerebrospinal fluid from the spinal needle hub. | During the insertion procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary Safety:Incidence of Any Needle or Procedure-related Spinal/Epidural Hematoma. | Incidence of device/procedure-related adverse events including the incidence of any spinal/epidural hematoma. | From insertion up to 7 days post procedure |
| Secondary Safety: Incidence of Any Needle or Procedure-related Nerve Damage (Pain or Weakness Lower Extremities). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. The ease-of-use survey was conducted among physician investigator to obtain information on BD spinal needle and related stylet performance. |
Inclusion Criteria:
Exclusion Criteria:
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Any participants who require a spinal needle device as part of their routine medical care.
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| Name | Affiliation | Role |
|---|---|---|
| Klaus Hoerauf, MD | Becton, Dickinson and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medizinische Universität Wien | Vienna | Austria | ||||
| Sejnjoen Central Hospital |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | All Participants | Participants who require a BD Spinal needle as part of their routine medical care. Spinal needle: Insertion of a spinal needle to perform the neuraxial procedure according to the clinical practice. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | Participants who require a BD Spinal needle as part of their routine medical care. Spinal needle: Insertion of a spinal needle to perform the neuraxial procedure according to the clinical practice. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Primary Safety: Incidence of Post-dural Puncture Headache (PDPH). | Percentage of participants with a diagnosis of PDPH in the 7 days following the anesthesia procedure. | 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. | Posted | Number | 95% Confidence Interval | % of subjects with a PDPH | From insertion up to 7 days post procedure |
|
From the BD Spina needle insertion up to 7 days post procedure
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.
An adverse device effect is defined asany adverse event that is considered tobe related to the use of an investigationalmedical device.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Participants | Participants who require a BD Spinal needle as part of their routine medical care. Spinal needle: Insertion of a spinal needle to perform the neuraxial procedure according to the clinical practice. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Procedural failure | General disorders | MedDRA 24.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Project Manager | Becton, Dickinson and Company | 00393452237718 | gloria.viti@bd.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 27, 2022 | Jul 24, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 28, 2022 | Jul 24, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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Incidence of any device or procedure-related adverse events, including the incidence of any nerve damage (pain or weakness lower extremities). |
| From insertion up to 7 days post procedure |
| Secondary Safety: Incidence of Any Needle or Procedure-related Infection (Meningitis, Spinal Abscess) | Incidence of device/procedure-related adverse events including the incidence of any infection (meningitis, spinal abscess) | From insertion up to 7 days post procedure |
| Secondary Safety: Incidence of Any Needle or Procedure-related Pain, Skin Redness, Irritation at or Near the Skin Puncture Site. | Incidence of device/procedure-related adverse events including the incidence of any pain, skin redness, irritation at or near the skin puncture site. | From insertion up to 7 days post procedure |
| Secondary Safety: Incidence of Any Needle or Procedure-related Backache. | Incidence of device/procedure-related adverse events including the incidence of backache. | From insertion up to 7 days post procedure |
| After spinal needle placement |
| Spinal Needle Placement Details - Ease of Use Survey Determined by a Composite Score of BD Spinal Introducer Performance Based on Post-insertion Survey. | 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. When 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. | After spinal needle placement |
| Spinal Needle Placement Details - Ease of Use Survey Determined by a Composite Score of BD Syringe Performance Based on Post-insertion Survey. | 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. When 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. | After spinal needle placement |
| Seinäjoki |
| 60220 |
| Finland |
| Charité Campus Benjamin Franklin | Berlin | 12203 | Germany |
| Universitätsklinikum Leipzig | Leipzig | 04103 | Germany |
| Hospital Universitario Quirónsalud Madrid | Madrid | 28223 | Spain |
| Schulthess Klinik, Zürich | Zurich | 8008 | Switzerland |
| Lost to Follow-up |
|
| General anesthesia at the request of the surgeon |
|
| Study physician not available for the anesthesia |
|
| Anesthesia rejected by the patient on the day of surgery |
|
| Device not listed in the study was used for the procedure |
|
| Surgery not performed |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Max Index | Mean | Standard Deviation | kg/m^2 |
|
| Primary diagnosis for intervention | Count of Participants | Participants |
|
| Reason for neuraxial procedure | Count of Participants | Participants |
|
| American Society of Anesthesiologists (ASA) physical status (PS) classification | 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 | Count of Participants | Participants |
|
| Spinal needle placement details- Participant position during spinal needle procedure | Count of Participants | Participants |
|
| Spinal needle placement details - Aseptic technique | Count of Participants | Participants |
|
| Spinal needle placement details - Local anesthesia | Count of Participants | Participants |
|
| Spinal needle placement details - Lumbar interspace | Lumbar interspace refers to last try with the spinal needle to achieve the spinal procedure. | Count of Participants | Participants |
|
| Spinal needle placement details - Number of Puncture attempts | Number of puncture attempts is the number of different needles attempted to achieve the spinal procedure. | Count of Participants | Participants |
|
| Spinal needle placement details - Number of Interspace levels attempts | The number of interspace levels attempts refers to the number of different lumbar interspace. | Count of Participants | Participants |
|
| Spinal needle placement details - Paresthesia verbalized by participant | Count of Participants | Participants |
|
| Spinal needle placement details - Spontaneous appearance of CSF emerging from the needle hub | 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 | Count of Participants | Participants |
|
| Spinal needle placement details - BD Spinal needle type | Count of Participants | Participants |
|
| Spinal needle placement details - BD Syringes | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Primary Performance: Incidence of Successful Needle Placement | Successful needle placement in the subarachnoid space defined as the appearance of cerebrospinal fluid from the spinal needle hub. | 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 | Posted | Number | 95% Confidence Interval | % of successful needle placement | During the insertion procedure |
|
|
|
| Secondary | Secondary Safety:Incidence of Any Needle or Procedure-related Spinal/Epidural Hematoma. | Incidence of device/procedure-related adverse events including the incidence of any spinal/epidural hematoma. | 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. | Posted | Number | 95% Confidence Interval | % of subject with a spinal hematoma | From insertion up to 7 days post procedure |
|
|
|
| Secondary | Secondary Safety: Incidence of Any Needle or Procedure-related Nerve Damage (Pain or Weakness Lower Extremities). | Incidence of any device or procedure-related adverse events, including the incidence of any nerve damage (pain or weakness lower extremities). | 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. | Posted | Number | 95% Confidence Interval | % of subject with a nerve damage | From insertion up to 7 days post procedure |
|
|
|
| Secondary | Secondary Safety: Incidence of Any Needle or Procedure-related Infection (Meningitis, Spinal Abscess) | Incidence of device/procedure-related adverse events including the incidence of any infection (meningitis, spinal abscess) | 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. | Posted | Number | 95% Confidence Interval | % of subject with an infection | From insertion up to 7 days post procedure |
|
|
|
| Secondary | Secondary Safety: Incidence of Any Needle or Procedure-related Pain, Skin Redness, Irritation at or Near the Skin Puncture Site. | Incidence of device/procedure-related adverse events including the incidence of any pain, skin redness, irritation at or near the skin puncture site. | 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. | Posted | Number | 95% Confidence Interval | % subjects with pain/readness/irritation | From insertion up to 7 days post procedure |
|
|
|
| Secondary | Secondary Safety: Incidence of Any Needle or Procedure-related Backache. | Incidence of device/procedure-related adverse events including the incidence of backache. | 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. | Posted | Number | 95% Confidence Interval | % of subjects with backache | From insertion up to 7 days post procedure |
|
|
|
| Other Pre-specified | 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. | 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. The ease-of-use survey was conducted among physician investigator to obtain information on BD spinal needle and related stylet performance. | 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. | Posted | Count of Participants | Participants | After spinal needle placement |
|
|
|
| Other Pre-specified | Spinal Needle Placement Details - Ease of Use Survey Determined by a Composite Score of BD Spinal Introducer Performance Based on Post-insertion Survey. | 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. When 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. | 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. | Posted | Count of Participants | Participants | After spinal needle placement |
|
|
|
| Other Pre-specified | Spinal Needle Placement Details - Ease of Use Survey Determined by a Composite Score of BD Syringe Performance Based on Post-insertion Survey. | 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. When 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. | 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. | Posted | Count of Participants | Participants | After spinal needle placement |
|
|
|
| 0 |
| 144 |
| 0 |
| 144 |
| 17 |
| 144 |
| Rhinitis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
|
| Injection site irritation | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
|
| Post lumbar puncture syndrome | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
|
| Puncture site pain | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
|
| Paresthesia | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 24.1 | Systematic Assessment |
|
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.
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
|
| PIs were agree or strongly agree with "stylet functioned properly during spinal needle placement". |
|
| Ease of BD Stylet removal from the spinal needle after placement was easy or very easy |
|
|