Prospective Clinical Evaluation of BD Spinal Needles

NCT05214560 | Completed Results

• 1 other identifier: MDS-20EPSPEU001
• Study Type: observational
• Target: 160
• Locations: 5 countries
• Sites: 6

Brief Summary

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

Conditions

Analgesia; Anesthesia

Outcome Measures

Primary Outcomes (2)

• Primary Safety: Incidence of Post-dural Puncture Headache (PDPH).

  Percentage of participants with a diagnosis of PDPH in the 7 days following the anesthesia procedure.

  From insertion up to 7 days post procedure

• Primary Performance: Incidence of Successful Needle Placement

  Successful needle placement in the subarachnoid space defined as the appearance of cerebrospinal fluid from the spinal needle hub.

  During the insertion procedure

Secondary Outcomes (5)

• Secondary Safety:Incidence of Any Needle or Procedure-related Spinal/Epidural Hematoma.

  From insertion up to 7 days post procedure

• Secondary Safety: Incidence of Any Needle or Procedure-related Nerve Damage (Pain or Weakness Lower Extremities).

  From insertion up to 7 days post procedure

• Secondary Safety: Incidence of Any Needle or Procedure-related Infection (Meningitis, Spinal Abscess)

  From insertion up to 7 days post procedure

• Secondary Safety: Incidence of Any Needle or Procedure-related Pain, Skin Redness, Irritation at or Near the Skin Puncture Site.

  From insertion up to 7 days post procedure

• Secondary Safety: Incidence of Any Needle or Procedure-related Backache.

  From insertion up to 7 days post procedure

Other Outcomes (3)

• Spinal Needle Placement Details - Ease of Use Survey Determined by a Composite Score of BD Spinal Needle and Related Stylet Performance Based on Post-insertion Survey.

  After spinal needle placement

• Spinal Needle Placement Details - Ease of Use Survey Determined by a Composite Score of BD Spinal Introducer Performance Based on Post-insertion Survey.

  After spinal needle placement

• Spinal Needle Placement Details - Ease of Use Survey Determined by a Composite Score of BD Syringe Performance Based on Post-insertion Survey.

  After spinal needle placement

Study Arms (1)

All participants

Participants who require a BD Spinal needle

Device: Spinal needle

Interventions

Spinal needle DEVICE

Insertion of a spinal needle to perform the neuraxial procedure.

All participants

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Any participants who require a spinal needle device as part of their routine medical care.

You may qualify if:

• 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.)

You may not qualify if:

• 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

Sponsors & Collaborators

• Becton, Dickinson and Company: lead
• Cromsource: collaborator

Study Sites (6)

Medizinische Universität Wien

Vienna, Austria

Location

Sejnjoen Central Hospital

Seinäjoki, 60220, Finland

Location

Charité Campus Benjamin Franklin

Berlin, 12203, Germany

Location

Universitätsklinikum Leipzig

Leipzig, 04103, Germany

Location

Hospital Universitario Quirónsalud Madrid

Madrid, 28223, Spain

Location

Schulthess Klinik, Zürich

Zurich, 8008, Switzerland

Location

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Clinical Project Manager
• Organization: Becton, Dickinson and Company

gloria.viti@bd.com

00393452237718

Study Officials

• Klaus Hoerauf, MD

  Becton, Dickinson and Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2022
• First Posted: January 28, 2022
• Study Start: February 14, 2022
• Primary Completion: July 22, 2022
• Study Completion: July 22, 2022
• Last Updated: August 19, 2024
• Results First Posted: August 19, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1); FI (1); CH (1); ES (1); DE (2)