Ignite Creation Date:
2024-05-06 @ 4:00 PM
Last Modification Date:
2024-10-26 @ 2:01 PM
Study NCT ID:
NCT04835428
Status:
RECRUITING
Last Update Posted:
2024-05-28
First Post:
2021-04-05
Brief Title:
STAND - Study of the AGN1 LOEP SV Kit Compared to PMMA in Patients with Vertebral Compression Fractures
Sponsor:
AgNovos Healthcare LLC
Organization:
AgNovos Healthcare LLC
Study Overview
Official Title:
A Randomized Single-Blinded Non-Inferiority Study Comparing AGN1 Local Osteo-Enhancement Procedure LOEP SV Kit Treatment of Vertebral Compression Fragility Fractures to PMMA Bone Cement Treatment
Status:
RECRUITING
Status Verified Date:
2024-09
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:
None
Brief Summary:
This is a multicenter single-blinded randomized controlled clinical trial evaluating the safety and efficacy of the AGN1 LOEP SV Kit for the treatment of painful vertebral compression fragility fractures VCFs The objective of this study is to demonstrate non-inferiority of the AGN1 LOEP SV Kit for the treatment of VCFs to standard of care vertebroplasty treatment using bipedicular injection of PMMA bone cement
Detailed Description:
Four hundred and eight 408 eligible subjects at up to twenty-five 25 study sites will be randomized 11 for treatment using the AGN1 LOEP SV Kit Intervention Group or PMMA bone cement Active Control Group
1 Intervention Group - receives vertebral augmentation of the target VCFs using the AGN1 LOEP SV Kit
2 Active Control Group - receives vertebral augmentation of the target VCFs using either Stryker VertaPlex HV or Medtronic Kyphon HV-R
Follow-up visits will be conducted at 7 days 28 days 3 months 12 months and 24 months after the procedure
1 Intervention Group - receives vertebral augmentation of the target VCFs using the AGN1 LOEP SV Kit
2 Active Control Group - receives vertebral augmentation of the target VCFs using either Stryker VertaPlex HV or Medtronic Kyphon HV-R
Follow-up visits will be conducted at 7 days 28 days 3 months 12 months and 24 months after the procedure
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| STAND | OTHER | AgNovos | None |