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Prospective Clinical Evaluation of BD NRFit™ Devices and Accessories.

NCT ID: NCT05953363

Last Updated: 2025-12-19

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

161 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-07-24

Study Completion Date

2024-06-07

Brief Summary

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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

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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.

Conditions

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Anesthesia Analgesia

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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All participants

Participants who require a BD NRFit™ Spinal Needles, NRFit™ Spinal Introducer Needles, and NRFit™ Syringes as part of their routine medical care.

BD NRFit™ Spinal Needles, BD NRFit™ Spinal Introducer Needles, and BD NRFit™ Syringes

Intervention Type DEVICE

Insertion of a BD NRFit™ spinal needle and optional BD NRFit™ Spinal Introducer Needle using a BD NRFit™ Syringe to perform the neuraxial procedure.

Interventions

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BD NRFit™ Spinal Needles, BD NRFit™ Spinal Introducer Needles, and BD NRFit™ Syringes

Insertion of a BD NRFit™ spinal needle and optional BD NRFit™ Spinal Introducer Needle using a BD NRFit™ Syringe to perform the neuraxial procedure.

Intervention Type DEVICE

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Becton, Dickinson and Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Klaus Hoerauf, MD

Role: STUDY_DIRECTOR

Becton, Dickinson and Company

Locations

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Barmherzige Bruder Krankenhaus Salzburg

Salzburg, , Austria

Site Status

Medizinische Universität Wien

Vienna, , Austria

Site Status

Charité Campus Benjamin Franklin

Berlin, , Germany

Site Status

Universitätsklinikum Leipzig

Leipzig, , Germany

Site Status

Hospital Universitario Quirónsalud Madrid

Madrid, , Spain

Site Status

Countries

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Austria Germany Spain

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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MDS-21NRFit001

Identifier Type: -

Identifier Source: org_study_id