Status:
COMPLETED
Prospective Clinical Evaluation of BD Spinal Needles
Lead Sponsor:
Becton, Dickinson and Company
Collaborating Sponsors:
Cromsource
Conditions:
Analgesia
Anesthesia
Eligibility:
All Genders
Brief Summary
Post-market, observational study to assess the real-world safety and efficacy of BD Spinal Needles used in an on-market fashion.
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 followe...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 14 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 22 2022
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT05214560
Start Date
February 14 2022
End Date
July 22 2022
Last Update
August 19 2024
Active Locations (6)
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1
Medizinische Universität Wien
Vienna, Austria
2
Sejnjoen Central Hospital
Seinäjoki, Finland, 60220
3
Charité Campus Benjamin Franklin
Berlin, Germany, 12203
4
Universitätsklinikum Leipzig
Leipzig, Germany, 04103