Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06386666
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-04-15
Brief Title:
A Clinical Trial to Evaluate the Safety and Efficacy of Single-use Fibrous Ring Sutures for the Suture of Fibrous Ring Incision After Nucleus Pulposus Removal
Sponsor:
Suzhou Kerui Medical Technology Co Ltd
Organization:
Suzhou Kerui Medical Technology Co Ltd
Study Overview
Official Title:
A Prospective Multicenter Single-group Target-value Clinical Trial to Evaluate the Safety and Efficacy of Single-use Annular Sutures for Annular Incisions Following Nucleus Pulposus Removal
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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:
The objective of this clinical trial was to evaluate the safety and effectiveness of single-use annular sutures for the closure of annular incisions after nucleus pulposus removal Participants used single-use annular sutures to close the annular fibers The success rate of suture reduction value of annulus proportion of annulus reduction intraoperative blood loss suture time VAS pain score low back bilateral lower extremities Oswestry index ODI index and Short were evaluated The effectiveness evaluation results of Form-12 health survey SF-12 score treatment success rate device defects product operation satisfaction and safety evaluation results of recurrence rate adverse events and serious adverse events were used to verify the safety and effectiveness of disposable fibrillar suture for annular incision suture after nucleus pulposus removal
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None