Prospective Clinical Evaluation of BD Spinal Needles

An observational study of Analgesia and Anesthesia, run by Becton, Dickinson and Company at 6 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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

Who is it for?: Any age
Conditions the study is for: Analgesia, Anesthesia
What is being tested?: Spinal needle
Type of treatment: Medical device
How many people: 160 participants
Where: 6 sitesin 5 countries
Study dates: 14 Feb 2022to 22 Jul 2022
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
Child, Adult, Older adult

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

Who may be able to join

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.)

Who cannot join

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

Trial locations and contacts

6 sites in 5 countries.

Country

City, postcode or hospital

6 sites in 5 countries

Germany2 sites

Charité Campus Benjamin Franklin
Berlin, 12203
Universitätsklinikum Leipzig
Leipzig, 04103

Other trials in Germany

Austria1 site

Medizinische Universität Wien
Vienna

Other trials in Austria

Finland1 site

Sejnjoen Central Hospital
Seinäjoki, 60220

Other trials in Finland

Spain1 site

Hospital Universitario Quirónsalud Madrid
Madrid, 28223

Other trials in Spain

Switzerland1 site

Schulthess Klinik, Zürich
Zurich, 8008

Other trials in Switzerland

About this study

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

Read the 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.

Conditions: Analgesia, Anesthesia
Being tested: Spinal needle
Medical subject headings: Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Spinal needleDevice
Insertion of a spinal needle to perform the neuraxial procedure.

Study groups in NCT05214560
Study group	Role	What they receive
All participants		Participants who require a BD Spinal needle Receives: Device: Spinal needle

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: During the insertion procedure

Secondary outcomes (5)

Secondary Safety:Incidence of Any Needle or Procedure-related Spinal/Epidural Hematoma.
Incidence of device/procedure-related adverse events including the incidence of any spinal/epidural hematoma.
Measured: From insertion up to 7 days post procedure
Secondary Safety: Incidence of Any Needle or Procedure-related Nerve Damage (Pain or Weakness Lower Extremities).
Incidence of any device or procedure-related adverse events, including the incidence of any nerve damage (pain or weakness lower extremities).
Measured: From insertion up to 7 days post procedure
Secondary Safety: Incidence of Any Needle or Procedure-related Infection (Meningitis, Spinal Abscess)
Incidence of device/procedure-related adverse events including the incidence of any infection (meningitis, spinal abscess)
Measured: 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.
Incidence of device/procedure-related adverse events including the incidence of any pain, skin redness, irritation at or near the skin puncture site.
Measured: From insertion up to 7 days post procedure
Secondary Safety: Incidence of Any Needle or Procedure-related Backache.
Incidence of device/procedure-related adverse events including the incidence of backache.
Measured: From insertion up to 7 days post procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Feb 202222 Jul 2022

First posted28 Jan 2022
Study start14 Feb 2022
Primary completion22 Jul 2022
Study completion22 Jul 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for AnalgesiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case only
Time perspective: Prospective
Enrolment: 160 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05214560
Sponsor's protocol ID: MDS-20EPSPEU001
Status last verified: Mar 2024
First submitted: 12 Jan 2022
Last updated: 19 Aug 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Analgesia trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prospective Clinical Evaluation of BD Spinal Needles
ClinicalTrials.gov ID: NCT05214560
Acronym / sponsor ID: MDS-20EPSPEU001
Conditions: Analgesia, Anesthesia
Study type: Observational
Recruitment status: Completed
Enrolment: 160 participants (actual)
Lead sponsor: Becton, Dickinson and CompanyIndustry (pharma, biotech, devices)
Collaborators: Cromsource
Study start: 14 Feb 2022 (actual)
Primary completion: 22 Jul 2022 (actual)
Study completion: 22 Jul 2022 (actual)
First posted: 28 Jan 2022 (actual)
Results: Posted 19 Aug 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

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

Observational model: Case only
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
All participants	–	Device: Spinal needleParticipants who require a BD Spinal needle

Who may qualify

Sex: All
Age groups: Child, Adult, Older adult
Study population: Any participants who require a spinal needle device as part of their routine medical care.

Key inclusion criteria (3 listed)

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.)

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Spinal needleInsertion of a spinal needle to perform the neuraxial procedure.	Device	All participants

Primary outcome

Primary Safety: Incidence of Post-dural Puncture Headache (PDPH).
Time frame: From insertion up to 7 days post procedure
Percentage of participants with a diagnosis of PDPH in the 7 days following the anesthesia procedure.
Primary Performance: Incidence of Successful Needle Placement
Time frame: During the insertion procedure
Successful needle placement in the subarachnoid space defined as the appearance of cerebrospinal fluid from the spinal needle hub.

5 secondary outcomes

Secondary Safety:Incidence of Any Needle or Procedure-related Spinal/Epidural Hematoma.
Time frame: From insertion up to 7 days post procedure
Secondary Safety: Incidence of Any Needle or Procedure-related Nerve Damage (Pain or Weakness Lower Extremities).
Time frame: From insertion up to 7 days post procedure
Secondary Safety: Incidence of Any Needle or Procedure-related Infection (Meningitis, Spinal Abscess)
Time frame: 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.
Time frame: From insertion up to 7 days post procedure
Secondary Safety: Incidence of Any Needle or Procedure-related Backache.
Time frame: From insertion up to 7 days post procedure

Results and safety

Results posted to the registry on 19 Aug 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Participants	160	142

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

Time frame: From insertion up to 7 days post procedure. Number (95% Confidence Interval). Unit: % of subjects with a PDPH

Measure	All Participants n = 142
Value	2.8 (0.8 to 7.1)

Population analysed: Out of 144 participants who received a neuraxial procedure, a total of 142 participants received a successful placement of the study device and were included in the safety set, used for the primary safety calculation.

Primary outcome: Primary Performance: Incidence of Successful Needle Placement

Time frame: During the insertion procedure. Number (95% Confidence Interval). Unit: % of successful needle placement

Measure	All Participants n = 144
Value	98.6 (95.1 to 99.8)

Population analysed: 160 subjects signed informed consent. As 1 subject was screening failure, and for other 15 subjects a study procedure was not attempted, the study device was attempted to be placed in 144 subjects: evaluable set, used for primary performance calculation.The study device could not be placed successfully in 1 subject due to pronounced left convex scoliosis and 1 subject with successful placement was not treated via the study device.142 subjects successfully received a placement of the study device

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: From the BD Spina needle insertion up to 7 days post procedure. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
All Participants	0 of 144 (0%)	17 of 144 (11.8%)	0 of 144

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Analgesia

RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Active, not recruiting
Efficacy of Laparoscopic-Assisted TAP Block in Laparoscopic Appendectomy
Appendectomy, Laparoscopic, Blockades Neuromuscular
Recruiting
SIRI Levels Following PENG Block in Pediatric Hip Surgery
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Not yet recruitingPhase 2
A Clinical Trial of MK-6916 in Participants With Pain After Bunion Removal Surgery (MK-6916-007)
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Klaus Hoerauf, MD study director

Becton, Dickinson and Company

6 sites in 5 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Analgesia and Anesthesia, run by Becton, Dickinson and Company at 6 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Germany, Austria, Finland, Spain, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary Safety: Incidence of Post-dural Puncture Headache (PDPH). (time frame: From insertion up to 7 days post procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05214560.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2024.