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Prospective Clinical Evaluation of BD Spinal Needles

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05214560
Recruitment Status : Recruiting
First Posted : January 28, 2022
Last Update Posted : May 9, 2022
Sponsor:
Collaborator:
Cromsource
Information provided by (Responsible Party):
Becton, Dickinson and Company

Study Description
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Brief Summary:
Post-market, observational study to assess the real-world safety and efficacy of BD Spinal Needles used in an on-market fashion.

Condition or disease Intervention/treatment
Analgesia Anesthesia Device: Spinal needle

Detailed Description:

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.

Study Design
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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Prospective Clinical Evaluation of BD Spinal Needles
Actual Study Start Date : February 10, 2022
Estimated Primary Completion Date : September 30, 2022
Estimated Study Completion Date : November 30, 2022
Groups and Cohorts
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Group/Cohort Intervention/treatment
All participants
Participants who require a BD Spinal needle
 Device: Spinal needle
Insertion of a spinal needle to perform the neuraxial procedure.


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of post-dural puncture headache (PDPH) [ Time Frame: From insertion up to 7 days post procedure ]
    Percentage of participants with a diagnosis of PDPH in the 7 days following the anesthesia procedure

  2. Incidence of successful needle placement [ Time Frame: During the insertion procedure ]
    Successful needle placement in the subarachnoid space defined as the appearance of cerebrospinal fluid from the spinal needle hub.


Secondary Outcome Measures :
  1. Incidence of any needle or procedure-related spinal/epidural hematoma [ Time Frame: From insertion up to 7 days post procedure ]
    Incidence of device/procedure-related adverse events including spinal/epidural hematoma

  2. Incidence of any needle or procedure-related nerve damage (pain or weakness lower extremities) [ Time Frame: From insertion up to 7 days post procedure ]
    Incidence of device/procedure-related adverse events including nerve damage (pain or weakness lower extremities)

  3. Incidence of any needle or procedure-related infection (meningitis, spinal abscess) [ Time Frame: From insertion up to 7 days post procedure ]
    Incidence of device/procedure-related adverse events including infection (meningitis, spinal abscess)

  4. Incidence of any needle or procedure-related pain, skin redness, irritation at or near the skin puncture site [ Time Frame: From insertion up to 7 days post procedure ]
    Incidence of device/procedure-related adverse events including pain, skin redness, irritation at or near the skin puncture site

  5. Incidence of any needle or procedure-related backache [ Time Frame: From insertion up to 7 days post procedure ]
    Incidence of device/procedure-related adverse events including backache


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Any participants who require a spinal needle device as part of their routine medical care.
Criteria

Inclusion Criteria:

  • 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
  • Expected to be available for observation through the study period (7-days post procedure)
  • 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.)

Exclusion Criteria:

  • Undergoing emergency surgery
  • Coagulopathy or bleeding disorder for which regional anesthesia poses an increased risk
  • History of neurological impairment or disease of the trunk or lower extremities.
  • Infection at or near the site of needle insertion
  • Previous spine surgery at the level involved in the study procedure
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05214560


Contacts
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Contact: Gloria Viti +39 3452237718 gloria.viti@bd.com
Contact: Winfried Huesmann +49 15154403197 winfried.huesmann@bd.com

Locations
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Finland
Sejnjoen Central Hospital Recruiting
Seinäjoki, Finland, 60220
Contact: Jaakko Sipilä         
Principal Investigator: Jaakko Sipilä         
Germany
Charité Campus Benjamin Franklin Recruiting
Berlin, Germany, 12203
Contact: Sascha Treskatsch         
Principal Investigator: Sascha Treskatsch         
Universitätsklinikum Leipzig Recruiting
Leipzig, Germany, 04103
Contact: Robert Werdehausen         
Principal Investigator: Robert Werdehausen         
Spain
Hospital Clínic. Barcelona Not yet recruiting
Barcelona, Spain, 08029
Contact: Xavier Sala-Blanch         
Principal Investigator: Xavier Sala-Blanch         
Hospital Universitario Quirónsalud Madrid Recruiting
Madrid, Spain, 28223
Contact: Jose Maria Marzal Barò         
Principal Investigator: Jose Maria Marzal Barò         
Switzerland
Schulthess Klinik, Zürich Recruiting
Zürich, Switzerland, 8008
Contact: Mital Dave         
Principal Investigator: Mital Dave         
Sponsors and Collaborators
Becton, Dickinson and Company
Cromsource
Investigators
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Study Director: Klaus Hoerauf, MD Becton, Dickinson and Company
More Information
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Responsible Party: Becton, Dickinson and Company
ClinicalTrials.gov Identifier: NCT05214560    
Other Study ID Numbers: MDS-20EPSPEU001
First Posted: January 28, 2022    Key Record Dates
Last Update Posted: May 9, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No