- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04821739
RISE - Study of the AGN1 LOEP SV Kit in Patients With Vertebral Compression Fractures
December 14, 2023 updated by: AgNovos Healthcare, LLC
A Prospective Multi-Center Study of the AGN1 Local Osteo-Enhancement Procedure (LOEP) SV Kit in Patients With Vertebral Compression Fractures (VCFs)
This study is a prospective, single-arm, multi-center, European clinical study designed to evaluate the clinical performance and safety of the AGN1 LOEP SV Kit for the treatment of painful VCFs.
Study Overview
Status
Recruiting
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Adam Lowe
- Phone Number: 240-753-6416
- Email: alowe@agnovos.com
Study Contact Backup
- Name: Allison Gorman
- Phone Number: 240-753-6424
- Email: agorman@agnovos.com
Study Locations
-
-
-
Offenbach, Germany
- Recruiting
- Sana Klinikum Offenbach GmbH
-
Principal Investigator:
- Mohammad Arab Motlagh, MD
-
Contact:
- Jana Brill
- Email: jb-clin.res@gmx.de
-
-
Hessen
-
Frankfurt, Hessen, Germany, 60528
- Recruiting
- Orthopedic University Hospital Friedrichsheim
-
Contact:
- Panagiotis Diaremes, MD
-
Principal Investigator:
- Panagiotis Diaremes, MD
-
-
-
-
-
Barcelona, Spain, 08035
- Recruiting
- Vall D'Hebron University Hospital
-
Contact:
- Eila Rivera Boix
- Email: eriverboix@gmail.com
-
Principal Investigator:
- Sleiman Haddadd, MD
-
Valladolid, Spain, 47006
- Recruiting
- Hospital Clínico Universitario de Valladolid
-
Contact:
- Adela Pereda
- Email: aperedama@gmail.com
-
Principal Investigator:
- David C Noriega Gonzalez, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
55 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Subject is a male or female ≥ 55 years of age at time of treatment.
- Subject is ≤ 85 years of age at time of treatment.
- Subject has only one (1) VCF. Note the adjacent level vertebral bodies
This VCF meets all of the following criteria:
- Fracture due to diagnosed or presumed underlying osteoporosis
- VCF from T6 to L5 inclusive
- Fracture age < 3 months at time of treatment
- Target VCF shows loss of height in the anterior or middle portion of the vertebral body of not more than 40% based on X-ray at baseline.
- Target VCF is acute or persistent (not healed), as demonstrated by T2 weighted STIR MRI or bone scan imaging.
- Subject has central pain upon palpation over the spinal process at the target vertebral body.
- Subject has failed conservative medical therapy, defined as either having a VAS back pain score of ≥ 70 mm after 2 to 6 weeks of conservative care or a VAS back pain score of ≥ 50 mm after 6 weeks of conservative care.
- Subject has an Oswestry Disability Index (ODI) score of ≥ 30%.
- Subject is capable of giving written informed consent to participate in the study.
- The subject's willingness, ability, and commitment to participate in screening, treatment, and all follow-up evaluations for the full length of the study has been documented.
Exclusion Criteria:
- Target VCF is due to underlying or suspected tumor.
- Target VCF is due to high-energy trauma.
- Target VCF is diagnosed as an osteonecrotic fracture.
- Target VCF has segmental kyphosis of > 30°.
- Target VCF is unstable including split or burst fractures.
- Subject has had any prior surgical treatment at the target VCF or adjacent vertebral level (above or below VCF).
- Subject has neurologic symptoms, deficits, or radiculopathy related to the VCF.
- Subject has spinal canal compromise causing clinical manifestations of cord, neural foramen, or nerve root compression at the level to be treated.
- Subject has pain based on clinical diagnosis of herniated nucleus pulposus or severe spinal stenosis (progressive weakness or paralysis).
- Subject has spondylolisthesis > Grade 1 at target vertebral body.
- Subject has pain due to any other condition that requires daily narcotic medication.
- Subject has severe cardiopulmonary deficiencies.
- Subject has a bleeding disorder.
- Subject has a Body Mass Index (BMI) > 35.
- Subject has a history of metabolic bone disease other than osteoporosis (e.g., Paget's disease, renal osteodystrophy, or osteomalacia).
- Subject has a history of tuberculosis spondylitis.
- Subject has a history of any invasive malignancy (except non-melanoma skin cancer), unless treated with curative intent and with no clinical signs or symptoms of the malignancy for five (5) years.
- Subject is on oral or parenteral immune-suppressive drugs.
- Subject has an active bone infection at target VCF.
- Subject has uncontrolled diabetes mellitus, as determined by the judgment of the Investigator.
- Subject has severe renal insufficiency defined as an estimated glomerular filtration rate (eGFR) < 30 mL/min.
- Subject has albumin corrected serum calcium levels outside the normal lab range or has a pre-existing calcium metabolism disorder (e.g., hypercalcemia).
- Subject has known allergies to calcium-based bone void fillers.
- Subject is pregnant or planning to become pregnant during participation in the study.
- In the judgment of the Investigator, the subject is not a good study candidate (e.g., inability to maintain follow-up schedule, comorbidity or poor general physical/mental health, or drug or alcohol abuse issues).
- Subject is currently enrolled in another interventional clinical study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment with AGN1 LOEP SV Kit
VCF is treated with the AGN1 LOEP SV Kit
|
The AGN1 LOEP SV Kit is intended for fixation of pathological fractures of the vertebral body using vertebral augmentation.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Back Pain from Baseline
Time Frame: 12 months
|
Change in Back Pain at 12 months from Baseline as indicated by Visual Analogue Scale (VAS), measured on a continuous 100 mm line.
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Mohammad Arab Motlagh, MD, Sana Klinikum Offenbach GmbH
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 19, 2021
Primary Completion (Estimated)
December 1, 2024
Study Completion (Estimated)
December 1, 2026
Study Registration Dates
First Submitted
March 11, 2021
First Submitted That Met QC Criteria
March 25, 2021
First Posted (Actual)
March 30, 2021
Study Record Updates
Last Update Posted (Estimated)
December 15, 2023
Last Update Submitted That Met QC Criteria
December 14, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AGN-CIP-200
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Vertebral Fracture
-
AgNovos Healthcare, LLCRecruitingVertebral Compression Fracture | Vertebral Compression | Compression FractureUnited States
-
University of Texas Southwestern Medical CenterMedtronicCompletedLumbar Vertebral FractureUnited States
-
Optimus Clinical ResearchCareFusionCompletedVertebral Compression Fractures | Osteoporotic Vertebral Compression Fractures | Acute Vertebral FracturesAustralia
-
University Hospital, Clermont-FerrandCompletedVertebrOpLasty Versus Conservative Treatment in Acute Non Osteoporotic Vertebral Fractures (VOLCANO)Vertebral Compression Fracture | Spinal TraumaFrance
-
Icahn School of Medicine at Mount SinaiRecruitingVertebral Compression Fractures | Osteoporotic Vertebral Compression FracturesUnited States
-
Jaseng Medical FoundationRecruitingVertebral Compression Fracture | Vertebral Compression | Korean Traditional Medicine | Integrative Korean MedicineKorea, Republic of
-
Hospital for Special Surgery, New YorkCompletedVertebral Compression FractureUnited States
-
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityRecruitingPrediction Model | Osteoporotic Vertebral FractureChina
-
Northwell HealthCompletedVertebral Fracture | Vertebral Compression | Vertebra Compression FractureUnited States
-
Mohammad ARAB MOTLAGHCompletedVertebral Body Fracture
Clinical Trials on AGN1 LOEP SV Kit
-
AgNovos Healthcare, LLCRecruitingVertebral Compression Fracture | Vertebral Compression | Compression FractureUnited States
-
AgNovos Healthcare, LLCCompletedHip Fractures | Osteoporosis, PostmenopausalHong Kong
-
AgNovos Healthcare, LLCRecruiting
-
AgNovos Healthcare, LLCAvania; BioClinica, Inc.; CMIC Co, Ltd. Japan; Emergent Clinical Consulting, LLCRecruitingHip Fractures | Osteoporosis | Fragility FractureDenmark, Spain, Netherlands, France, Germany, Japan, Italy, Austria, United Kingdom
-
AgNovos Healthcare, LLCKCR S.A.; genae GroupCompleted