Prospective Clinical Evaluation of BD Spinal Needles

Becton, Dickinson and Company (BD)

Status

Completed

Conditions

Analgesia

Anesthesia

Treatments

Device: Spinal needle

Study type

Observational

Funder types

Industry

Identifiers

NCT05214560

MDS-20EPSPEU001

Details and patient eligibility

About

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

Full 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.

Enrollment

160 patients

Sex

All

Volunteers

No Healthy Volunteers

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