Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06375759
Status:
RECRUITING
Last Update Posted:
2024-04-19
First Post:
2024-04-16
Brief Title:
Subarachnoid-Subarachnoid S-S Bypass Versus Adhesion Lysis in Spinal Arachnoiditis and Syringomyelia
Sponsor:
Xuanwu Hospital Beijing
Organization:
Xuanwu Hospital Beijing
Study Overview
Official Title:
Subarachnoid-Subarachnoid S-S Bypass Versus Adhesion Lysis in Spinal Arachnoiditis and Syringomyelia
Status:
RECRUITING
Status Verified Date:
2024-04
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:
To determine whether Subarachnoid-Subarachnoid S-S Bypass results in better patient outcomes with fewer complications and improved quality of life compared to intradural adhesion lysis in individuals with Spinal Arachnoiditis and Syringomyelia
Detailed Description:
Participants with Spinal Arachnoiditis and Syringomyelia will be randomized to either have a Subarachnoid-Subarachnoid S-S Bypass or intradural adhesion Lysis The participant will then return to the neurosurgeons office at the following time points which are consistent with standard of care practice 3-6 months 12 and 24 months At these visits the clinician will complete a physical exam and the participant will report on the prognosis of symptoms and complete questionnaires A spine MRI will be performed 3-6 months 12 and 24 months after the decompression
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