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

NCT04821739 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-05-13

No results posted yet for this study

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

Interventions

DEVICE

AGN1 LOEP SV Kit

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

Sponsors & Collaborators

  • AgNovos Healthcare, LLC

    lead INDUSTRY

Principal Investigators

  • Mohammad Arab Motlagh, MD · Sana Klinikum Offenbach GmbH

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-19
Primary Completion
2027-12-01
Completion
2028-12-01
FDA Device
Yes

Countries

  • Germany
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04821739 on ClinicalTrials.gov