Prospective Clinical Evaluation of BD Spinal Needles

Sponsor

Becton, Dickinson and Company (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT05214560

Collaborator

Cromsource (Industry)

150

Enrollment

Locations

5.6

Anticipated Duration (Months)

Patients Per Site

4.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Analgesia Anesthesia	Device: Spinal needle

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 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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

150 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

Prospective Clinical Evaluation of BD Spinal Needles

Actual Study Start Date :

Feb 10, 2022

Anticipated Primary Completion Date :

Jul 30, 2022

Anticipated Study Completion Date :

Jul 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
All participants Participants who require a BD Spinal needle	Device: Spinal needle Insertion of a spinal needle to perform the neuraxial procedure.

Arm

Intervention/Treatment

All participants

Participants who require a BD Spinal needle

Device: Spinal needle

Insertion of a spinal needle to perform the neuraxial procedure.

Outcome Measures

Primary Outcome Measures

Incidence of post-dural puncture headache (PDPH) [From insertion up to 7 days post procedure]
Percentage of participants with a diagnosis of PDPH in the 7 days following the anesthesia procedure
Incidence of successful needle placement [During the insertion procedure]
Successful needle placement in the subarachnoid space defined as the appearance of cerebrospinal fluid from the spinal needle hub.

Secondary Outcome Measures

Incidence of any needle or procedure-related spinal/epidural hematoma [From insertion up to 7 days post procedure]
Incidence of device/procedure-related adverse events including spinal/epidural hematoma
Incidence of any needle or procedure-related nerve damage (pain or weakness lower extremities) [From insertion up to 7 days post procedure]
Incidence of device/procedure-related adverse events including nerve damage (pain or weakness lower extremities)
Incidence of any needle or procedure-related infection (meningitis, spinal abscess) [From insertion up to 7 days post procedure]
Incidence of device/procedure-related adverse events including infection (meningitis, spinal abscess)
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]
Incidence of device/procedure-related adverse events including pain, skin redness, irritation at or near the skin puncture site
Incidence of any needle or procedure-related backache [From insertion up to 7 days post procedure]
Incidence of device/procedure-related adverse events including backache

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Medizinische Universität Wien	Wien	Austria
2	Sejnjoen Central Hospital	Seinäjoki	Finland	60220
3	Charité Campus Benjamin Franklin	Berlin	Germany	12203
4	Universitätsklinikum Leipzig	Leipzig	Germany	04103
5	Hospital Universitario Quirónsalud Madrid	Madrid	Spain	28223
6	Schulthess Klinik, Zürich	Zürich	Switzerland	8008

Sponsors and Collaborators

Becton, Dickinson and Company
Cromsource

Investigators

Study Director: Klaus Hoerauf, MD, Becton, Dickinson and Company

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Becton, Dickinson and Company

ClinicalTrials.gov Identifier:

NCT05214560

Other Study ID Numbers:

MDS-20EPSPEU001

First Posted:

Jan 28, 2022

Last Update Posted:

Jul 18, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jul 18, 2022