Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06615505
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-24
Brief Title:
ASCEND a Clinical Trial to Evaluate the Safety and Effectiveness of VIA Disc NP a Supplement for Degenerated Intervertebral Discs
Sponsor:
None
Organization:
None
Study Overview
Official Title:
ASCEND a Randomized Double Blind Sham-Controlled Multi-Center Phase III Clinical Trial to Evaluate the Safety and Effectiveness of VIA Disc NP a Supplement for Degenerated Intervertebral Discs
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ASCEND
Brief Summary:
VIA Disc NP is an off-the-shelf minimally processed human nucleus pulposus tissue allograft intended to supplement degenerated intervertebral discs
The study is a randomized double-blind sham-controlled multi-center study in participants with symptomatic lumbar intervertebral disc degeneration 6 months and unresponsive to conservative therapy for at least 3 months Participants will be randomized on a 11 basis to receive either a single VIA Disc NP intradiscal injection at 1 or 2 levels or a sham procedure at 1 or 2 levels
The study is a randomized double-blind sham-controlled multi-center study in participants with symptomatic lumbar intervertebral disc degeneration 6 months and unresponsive to conservative therapy for at least 3 months Participants will be randomized on a 11 basis to receive either a single VIA Disc NP intradiscal injection at 1 or 2 levels or a sham procedure at 1 or 2 levels
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None