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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: Recruiting NA study of Vertebral Compression Fracture and Vertebral Compression, sponsored by AgNovos Healthcare.
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, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (71% lower). The trial reports 19 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Change in VCF-related pain by \> 20 mm from baseline as measured by a 100 mm Visual Analogue Scale (VAS) where 0mm is no pain, and 100mm is worst pain possible.
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 |
What NCT04835428 shows while recruiting
NCT04835428 is an interventional study that assigns participants to a tested intervention. The registered 408 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (71% lower).
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 lists 19 locations in 13 states (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.
Learn More About Clinical Trials
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Where NCT04835428's enrollment target sits among peer trials
408 243rd of 2000 higher than 1,758 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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