RISE - Study of the AGN1 LOEP SV Kit in Patients With Vertebral Compression Fractures

NCT04821739 | Recruiting FDA Device

• 1 other identifier: AGN-CIP-200
• Study Type: interventional
• Target: 100
• Locations: 2 countries
• Sites: 4

Brief 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.

Conditions

Vertebral Compression Fracture; Vertebral Compression; Vertebral Fracture

Keywords

LOEP; AGN1; RISE; Local Osteo-Enhancement Procedure

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months

Study Arms (1)

Treatment with AGN1 LOEP SV Kit

EXPERIMENTAL

VCF is treated with the AGN1 LOEP SV Kit

Device: AGN1 LOEP SV Kit

Interventions

AGN1 LOEP SV Kit DEVICE

The AGN1 LOEP SV Kit is intended for fixation of pathological fractures of the vertebral body using vertebral augmentation.

Treatment with AGN1 LOEP SV Kit

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• AgNovos Healthcare, LLC: lead

Study Sites (4)

Orthopedic University Hospital Friedrichsheim

Frankfurt am Main, Hesse, 60528, Germany

WITHDRAWN

Sana Klinikum Offenbach GmbH

Offenbach, Germany

RECRUITING

Hospital Clinico Universitario de Valladolid

Valladolid, Valladolid, 47006, Spain

RECRUITING

Vall d'Hebron University Hospital

Barcelona, 08035, Spain

RECRUITING

MeSH Terms

Conditions

Spinal Fractures

Condition Hierarchy (Ancestors)

Spinal Injuries; Back Injuries; Wounds and Injuries; Fractures, Bone

Study Officials

• Mohammad Arab Motlagh, MD

  Sana Klinikum Offenbach GmbH

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Adam Lowe

CONTACT

240-753-6416; alowe@agnovos.com

Allison Gorman

CONTACT

240-753-6424; agorman@agnovos.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2021
• First Posted: March 30, 2021
• Study Start: May 19, 2021
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: March 28, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2); DE (2)