Vertebral Compression FractureNCT04821739
RISE - Study of the AGN1 LOEP SV Kit in Patients With Vertebral Compression Fractures
A study testing AGN1 LOEP SV Kit in people with Vertebral Compression Fracture and Vertebral Compression, run by AgNovos Healthcare, LLC at 3 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Vertebral Compression Fracture, Vertebral Compression, Vertebral Fracture
- What is being tested?
- AGN1 LOEP SV Kit
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 19 May 2021to 1 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is a male or female 50 years of age or older at time of study treatment.
- Criterion omitted
- Subject has only one (1) acute VCF. Subjects are eligible if they have an asymptomatic healed VCF at any non-target vertebral level.
- This VCF meets all of the following criteria:
- Fracture due to diagnosed or presumed underlying osteoporosis
- VCF from T1 to L5 inclusive
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- Fracture age ≤6 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 50% based on X-ray at baseline.
- Target VCF is acute or persistent (not healed), as demonstrated by T2 weighted STIR MRI, bone scan, CT, serial radiographs, or other imaging demonstrating acuity.
- 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 24 hours 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.
Who cannot join
- 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).
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- 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 a diagnosed calcium metabolism disorder.
- 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.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Spain2 sites
Vall d'Hebron University Hospital
Barcelona, 08035
Hospital Clinico Universitario de Valladolid
Valladolid, Valladolid, 47006
About this study
Official title: 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.
Read the detailed description
A maximum of 100 subjects will be treated at up to 10 study sites across Europe. Follow up visits will be conducted at 1 day, 1 month, 3 months, 12 months and 24 months after the procedure.
Study enrollment will occur in three stages:
Stage 1: 5 subjects to evaluate safety at 3 months Stage 2: 30 subjects to evaluate safety at 3 months Stage 3: 100 subjects to evaluate safety and performance at 12 months
- Being tested
- AGN1 LOEP SV Kit
- Keywords
- LOEP, AGN1, RISE, Local Osteo-Enhancement Procedure
- Medical subject headings
- Spinal Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AGN1 LOEP SV KitDevice
The AGN1 LOEP SV Kit is intended for fixation of pathological fractures of the vertebral body using vertebral augmentation.
| Study group | Role | What they receive |
|---|---|---|
| Treatment with AGN1 LOEP SV Kit | Experimental | VCF is treated with the AGN1 LOEP SV Kit Receives: Device: AGN1 LOEP SV Kit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Back Pain from Baseline
Change in Back Pain at 12 months from Baseline as indicated by Visual Analogue Scale (VAS), measured on a continuous 100 mm line.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2021
- Study start19 May 2021
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vertebral Compression FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AgNovos Healthcare, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mohammad Arab Motlagh, MD, Principal investigator, Sana Klinikum Offenbach GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04821739
- Sponsor's protocol ID
- AGN-CIP-200
- Status last verified
- May 2026
- First submitted
- 11 Mar 2021
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multi-Center Study of the AGN1 Local Osteo-Enhancement Procedure (LOEP) SV Kit in Patients With Vertebral Compression Fractures (VCFs)
- ClinicalTrials.gov ID
- NCT04821739
- Acronym / sponsor ID
- AGN-CIP-200
- Keywords
- LOEP, AGN1, RISE, Local Osteo-Enhancement Procedure
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- AgNovos Healthcare, LLCIndustry (pharma, biotech, devices)
- Study start
- 19 May 2021 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 30 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
A maximum of 100 subjects will be treated at up to 10 study sites across Europe. Follow up visits will be conducted at 1 day, 1 month, 3 months, 12 months and 24 months after the procedure.
Study enrollment will occur in three stages:
Stage 1: 5 subjects to evaluate safety at 3 months Stage 2: 30 subjects to evaluate safety at 3 months Stage 3: 100 subjects to evaluate safety and performance at 12 months
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment with AGN1 LOEP SV Kit | Experimental | Device: AGN1 LOEP SV KitVCF is treated with the AGN1 LOEP SV Kit |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Subject is a male or female 50 years of age or older at time of study treatment.
- Criterion omitted
- Subject has only one (1) acute VCF. Subjects are eligible if they have an asymptomatic healed VCF at any non-target vertebral level.
- This VCF meets all of the following criteria:
- Target VCF shows loss of height in the anterior or middle portion of the vertebral body of not more than 50% based on X-ray at baseline.
Key exclusion criteria (26 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AGN1 LOEP SV KitThe AGN1 LOEP SV Kit is intended for fixation of pathological fractures of the vertebral body using vertebral augmentation. | Device | Treatment with AGN1 LOEP SV Kit |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohammad Arab Motlagh, MD principal investigator
Sana Klinikum Offenbach GmbH
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AGN1 LOEP SV Kit in people with Vertebral Compression Fracture and Vertebral Compression, run by AgNovos Healthcare, LLC at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Back Pain from Baseline (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2026.