Prospective Clinical Evaluation of BD Spinal Needles

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

160 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-02-14

Study Completion Date

2022-07-22

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Analgesia Anesthesia

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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All participants

Participants who require a BD Spinal needle

Spinal needle

Intervention Type DEVICE

Insertion of a spinal needle to perform the neuraxial procedure.

Interventions

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Spinal needle

Insertion of a spinal needle to perform the neuraxial procedure.

Intervention Type DEVICE

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

No