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Medical Device

AGN1 LOEP SV Kit for VCFs (STAND Trial)

N/A
Recruiting
Led By Kern Singh
Research Sponsored by AgNovos Healthcare, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subject is a male or female aged 55 and 85 years, inclusive, of age at time of study treatment.
Subject has an Oswestry Disability Index (ODI) score of ≥ 30% at baseline.
Must not have
Subject has severe cardiopulmonary deficiencies.
Subject has a bleeding disorder.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new device called the AGN1 LOEP SV Kit for patients with painful spinal fractures. The device works by stabilizing the broken bone in the spine to reduce pain.

Who is the study for?
This trial is for men and women aged 55 to 85 with a single painful vertebral compression fracture (VCF) that hasn't healed within 6 months despite conservative treatments. Participants must have significant disability from the VCF, no high-energy trauma or tumor-related fractures, not be severely overweight, and have no major health issues like uncontrolled diabetes or severe heart/lung problems.
What is being tested?
The STAND trial is testing the AGN1 LOEP SV Kit against PMMA bone cement in treating vertebral compression fractures. It's a multicenter study where participants are randomly assigned to one of these treatments to see if AGN1 is just as safe and effective as the standard PMMA treatment.
What are the potential side effects?
While specific side effects aren't listed here, similar procedures may cause pain at the injection site, new fractures on adjacent vertebrae due to increased stiffness at the treated level, nerve damage resulting in numbness or tingling, bleeding, infection risks around the spine area.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 55 and 85 years old.
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My back pain significantly limits my daily activities.
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My back pain remains severe despite trying many treatments for over 6 weeks.
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I have been diagnosed with or am presumed to have osteoporosis.
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My imaging tests show that my vertebral compression fracture is recent or not healed.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have severe heart or lung problems.
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I have a bleeding disorder.
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My spine cannot safely support certain surgical tools.
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I have spinal issues causing nerve pain or problems in the area needing treatment.
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I have a disorder that affects how my body handles calcium.
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My spine condition is more severe than a mild slip.
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I have pain, weakness, or paralysis from a herniated disc or spinal narrowing.
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My kidney function is severely low.
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My blood clot is suspected to be caused by a tumor.
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I am currently being treated for an infection in my spine with antibiotics.
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I have a bone condition that is not osteoporosis.
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I need daily opioid painkillers for a condition not related to my vertebral compression fracture.
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I have nerve symptoms due to a spinal fracture.
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I have had tuberculosis of the spine.
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My spinal fracture is caused by bone tissue death.
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I have had surgery on my spine or near the target area before.
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I am taking medication that suppresses my immune system.
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I have diabetes that is not well-managed.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Adverse events
Change in VCF-related Pain as measured by a 100 mm Visual Analogue Scale (VAS)
Change in function
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Treatment with AGN1 LOEP SV KitExperimental Treatment1 Intervention
The AGN1 LOEP SV Kit is intended for fixation of pathological fractures of the vertebral body using vertebral augmentation. Following saline lavage to create space, the AGN1 implant material is injected and hardens in situ to augment the fractured vertebral body. The AGN1 implant material is then resorbed and replaced with new bone.
Group II: Treatment with PMMA bone cementActive Control1 Intervention
High viscosity PMMA bone cement will be used for vertebral augmentation.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for vertebral compression fractures (VCFs) include vertebroplasty and kyphoplasty. Both procedures involve the injection of bone cement (such as PMMA) into the fractured vertebra to stabilize it. Vertebroplasty directly injects the cement to provide immediate pain relief and stabilization, while kyphoplasty first uses a balloon to create a cavity and restore some vertebral height before cement injection. These treatments are crucial for VCF patients as they help reduce pain, improve mobility, and prevent further vertebral collapse. The AGN1 LOEP SV Kit, similar to these treatments, aims to provide minimally invasive stabilization, which is essential for reducing recovery time and improving patient outcomes.

Find a Location

Who is running the clinical trial?

AgNovos Healthcare, LLCLead Sponsor
7 Previous Clinical Trials
2,827 Total Patients Enrolled
1 Trials studying Vertebral Compression Fractures
100 Patients Enrolled for Vertebral Compression Fractures
Kern SinghPrincipal InvestigatorMidwest Orthopedics at Rush

Media Library

AGN1 LOEP SV Kit (Medical Device) Clinical Trial Eligibility Overview. Trial Name: NCT04835428 — N/A
Vertebral Compression Fractures Research Study Groups: Treatment with AGN1 LOEP SV Kit, Treatment with PMMA bone cement
Vertebral Compression Fractures Clinical Trial 2023: AGN1 LOEP SV Kit Highlights & Side Effects. Trial Name: NCT04835428 — N/A
AGN1 LOEP SV Kit (Medical Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04835428 — N/A
Vertebral Compression Fractures Patient Testimony for trial: Trial Name: NCT04835428 — N/A
~133 spots leftby Dec 2025