Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2026-01-03 @ 6:29 AM
Study NCT ID:
NCT05214560
Status:
COMPLETED
Last Update Posted:
2024-08-19
First Post:
2022-01-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Prospective Clinical Evaluation of BD Spinal Needles
Sponsor:
Becton, Dickinson and Company
Organization:
Study Overview
Official Title:
Prospective Clinical Evaluation of BD Spinal Needles
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: