Clinical trial NCT05953363: Prospective Clinical Evaluation of BD NRFit™ Devices and Accessories.
Official title: Multi-center, Prospective, Open Label, Single Arm Post-market Study of BD NRFit™ Spinal Needles, NRFit™ Spinal Introducer Needles, and NRFit™ Syringes on Participants Who Are Receiving Neuraxial Procedure.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anesthesia
Analgesia
Lead sponsor: Becton, Dickinson and Company
Sponsor class: INDUSTRY
First posted: 2023-07-20
Enrollment: 161
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who will receive a spinal anesthesia procedure as part of their routine medical care.

Brief summary: Multi-center, prospective, open label, single arm post-market study to assess the real-world safety and efficacy of BD NRFit™ Spinal Needles, BD NRFit™ Spinal Introducer Needles, and BD NRFit™ Syringes used in an on-market fashion.

Detailed description: This is a multi-center, prospective, open label, single arm post-market study that will enroll approximately 180 participants in order to have a minimum of 150 treated participants who will receive a spinal anesthesia procedure as part of their routine medical care. Participants will be followed from the time of enrollment for up to 10 days (± 3 days) post spinal anesthesia procedure for evidence of adverse events including Post Dural Puncture Headache (PDPH). This can be done via phone if the participant is discharged from the hospital. The site staff must take advantage of the time window of ± 3 days only when the 10-day post-procedure occurs during the weekends or holidays. Any adverse event or complication must be diagnosed and confirmed by a study physician.

A minimum of 50 participants for each of the two needle tip types (Quincke and Whitacre tip) will be enrolled in the study.

Eligibility criteria: Inclusion Criteria:

1. Any patient, regardless of age or gender, for which the investigator has decided that a neuraxial procedure must be performed utilizing BD NRFit™ Spinal Needles, NRFit™ Spinal Introducer Needles, and NRFit™ Syringes as part of their routine medical care.
2. Expected to be available for observation through the study period (10 days, ± 3 days, post procedure\*).
3. Able and willing to provide signed and dated informed consent or legal authorized representative (LAR) authorized to give consent on behalf of the participant (Note: Consent of guardian or parent may be required for participants under the age of 18 years; participant assent may be required as well).

Exclusion Criteria:

1. Coagulopathy or bleeding disorder, where it is in the opinion of the investigator makes regional anesthetic of increased risk.
2. Subjects with a history of neurological impairment of the trunk or lower extremities.
3. Infection at the site of needle insertion.
4. Previous spine surgery at the level involved in the study procedure.

Primary outcomes:
measure: Primary Performance
timeFrame: During insertion procedure
measure: Primary Performance
timeFrame: During insertion procedure
measure: Primary Performance
timeFrame: During insertion procedure
measure: Primary Performance
timeFrame: During insertion procedure
measure: Primary Safety
timeFrame: From insertion up to 10 (± 3 days) post procedure
measure: Primary Safety
timeFrame: From insertion up to 10 (± 3 days) post procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Salzburg
country: Austria
facility: Barmherzige Bruder Krankenhaus Salzburg
city: Wien
country: Austria
facility: Medizinische Universität Wien
city: Berlin
country: Germany
facility: Charité Campus Benjamin Franklin
city: Leipzig
country: Germany
facility: Universitätsklinikum Leipzig
city: Madrid
country: Spain
facility: Hospital Universitario Quirónsalud Madrid
Study officials:
affiliation: Becton, Dickinson and Company
name: Klaus Hoerauf, MD
role: STUDY_DIRECTOR
References: