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NCT04835428 · ClinicalTrials.gov registry record · NA
STAND - Study of the AGN1 LOEP SV Kit Compared to PMMA in Patients With Vertebral Compression Fractures
A NA study of Vertebral Compression Fracture and Vertebral Compression, sponsored by AgNovos Healthcare.
- Recruiting
- Registry status
- NA
- Development phase
- 408
- Enrollment target
- 19
- Study locations
NCT04835428 is a NA study of Vertebral Compression Fracture and Vertebral Compression that is actively recruiting participants, run by AgNovos Healthcare. The registered enrollment target is 408 participants. The trial reports 19 study locations across 13 states.
The verdict
NCT04835428, a NA study of Vertebral Compression Fracture and Vertebral Compression, is actively recruiting participants, sponsored by AgNovos Healthcare.
- RECRUITING
- Registry status
- NA
- Development phase
- 408 participants
- Enrollment target
- 19
- Study locations
Study 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.
Conditions Studied
Interventions
- DEVICE Treatment Group: AGN1 LOEP SV Kit
- DEVICE Control Group: PMMA bone cement
Study Locations (19)
Illinois
- Rush University Medical Center - Chicago
- NorthShore University HealthSystem - Evanston
- Duly Health / NextStage Clinical Research - Naperville
Arizona
- Elite Pain and Spine Institute - Mesa
- Mayo Clinic - Phoenix
Florida
- Orlando Neurosurgery (Conquest Research) - Orlando
- Cleveland Clinic Florida - Stuart
Kansas
- University of Kansas Medical Center Research Institute, Inc. - Kansas City
- Abay Neuroscience Center / NextStage Clinical Research - Wichita
New York
- Mt. Sinai - New York
- Montefiore - The Bronx
Alabama
- Alabama Clinical Therapeutics - Birmingham
District of Columbia
- GW Medical Faculty Associates - Washington D.C.
Louisiana
- Louisiana Spine Institute - Shreveport
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 408 participants |
| Start Date | 2022-05-31 |
| Est. Completion | 2027-12-31 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04835428
The ClinicalTrials.gov registry entry for NCT04835428 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 408 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AgNovos Healthcare, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Vertebral Compression Fracture appearing as the primary indexed condition, and to 2 interventions - of which Treatment Group: AGN1 LOEP SV Kit is the first listed.
NCT04835428 reports 19 study locations spanning 13 distinct geographic areas - top geographies include Illinois, Arizona, Florida.
Frequently Asked Questions
What is clinical trial NCT04835428 about?
NCT04835428 is a clinical study titled "STAND - Study of the AGN1 LOEP SV Kit Compared to PMMA in Patients With Vertebral Compression Fractures". 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 ...
What is the current status of trial NCT04835428?
This trial is currently recruiting. It is a NA study. The enrollment target is 408 participants. The study started on 2022-05-31. Estimated completion is 2027-12-31.
What conditions does trial NCT04835428 study?
This clinical trial studies the following conditions: Vertebral Compression Fracture, Vertebral Compression, Compression Fracture.
What interventions are being tested in trial NCT04835428?
The interventions under investigation include: Treatment Group: AGN1 LOEP SV Kit (DEVICE), Control Group: PMMA bone cement (DEVICE).
Who is sponsoring clinical trial NCT04835428?
This trial is sponsored by AgNovos Healthcare, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04835428 being conducted?
This trial has 19 study locations across Alabama, Arizona, District of Columbia, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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