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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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
STAND Trial Summary
This trial is testing a new treatment for painful VCFs (vertebral compression fractures) to see if it is non-inferior to the current standard of care.
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.Check my eligibility
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.See study design
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.
STAND Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 55 and 85 years old.
Select...
My back pain significantly limits my daily activities.
Select...
My back pain remains severe despite trying many treatments for over 6 weeks.
Select...
I have been diagnosed with or am presumed to have osteoporosis.
Select...
My imaging tests show that my vertebral compression fracture is recent or not healed.
STAND Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Adverse events
Change in VCF-related Pain as measured by a 100 mm Visual Analogue Scale (VAS)
Change in function
+2 moreSTAND 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.
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have severe heart or lung problems.My kidney function is severely low.I had cancer other than non-melanoma skin cancer in the last 5 years, or I had any cancer over 5 years ago but now am symptom-free.I am between 55 and 85 years old.I have a bleeding disorder.My spine cannot safely support certain surgical tools.I have spinal issues causing nerve pain or problems in the area needing treatment.I have a disorder that affects how my body handles calcium.My spine condition is more severe than a mild slip.I have pain, weakness, or paralysis from a herniated disc or spinal narrowing.My pain from vertebral compression fractures has been for 6 months or less.My blood clot is suspected to be caused by a tumor.My spine is tender at the site of my vertebral fracture, confirmed by an exam.I am currently being treated for an infection in my spine with antibiotics.My back pain significantly limits my daily activities.I have a bone condition that is not osteoporosis.I need daily opioid painkillers for a condition not related to my vertebral compression fracture.I have nerve symptoms due to a spinal fracture.I have had tuberculosis of the spine.My condition affects my spine from the top to the lower back.I am able to understand and sign the consent form.My back pain remains severe despite trying many treatments for over 6 weeks.I have only one recent vertebral compression fracture.My spinal fracture is caused by bone tissue death.I have had surgery on my spine or near the target area before.I am taking medication that suppresses my immune system.I have diabetes that is not well-managed.I have been diagnosed with or am presumed to have osteoporosis.My imaging tests show that my vertebral compression fracture is recent or not healed.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment with AGN1 LOEP SV Kit
- Group 2: Treatment with PMMA bone cement
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Vertebral Compression Fractures Patient Testimony for trial: Trial Name: NCT04835428 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals are participating in this experiment?
"Indeed, the data hosted on clinicaltrials.gov affirms that this medical study is seeking out volunteers. This trial was initially posted on May 31st 2022 and modified as recently as November 28th 2022; it requires 408 patients from 15 distinct centres."
Answered by AI
Is there any possibility I may be approved to participate in this investigative research?
"This clinical trial aims to enlist 408 participants aged 55-85 with fractures and compression. To qualify, one must satisfy these criteria."
Answered by AI
Is access to this clinical research being offered at the present time?
"According to the clinicaltrials.gov database, this trial is actively recruiting participants as of now; it was first posted on May 31st 2022 and revised most recently on November 28th 2022."
Answered by AI
Are individuals aged 85 or younger accepted for participation in this experiment?
"According to the qualifications listed, individuals aged 55 to 85 are suitable applicants for this experiment. Additionally, there exists 66 trials specifically catered towards minors and 287 experiments designed with seniors in mind."
Answered by AI
How widespread is the implementation of this experiment?
"The University of Kansas Medical Center Research Institute, Inc. in Kansas City is the primary research institute overseeing this medical trial as well as GW Medical Faculty Associates located in Washington and Mt. Sinai based in New york along with 15 other sites around the United States."
Answered by AI
Who else is applying?
What state do they live in?
Florida
Texas
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0
3+
What site did they apply to?
Cleveland Clinic Florida
Texas Back Institute
Why did patients apply to this trial?
I have debilitating back pain and I have went through epidural injections for my back MRI studies and also my sciatic nerve is in pain.
PatientReceived 1 prior treatment
What questions have other patients asked about this trial?
When does it start?
PatientReceived 2+ prior treatments
How responsive is this trial?
Average response time
- < 2 Days
Typically responds via
Phone Call
Most responsive sites:
- Texas Back Institute: < 48 hours
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