NCT04821739

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

A Prospective Multi-Center Study of the AGN1 Local Osteo-Enhancement Procedure (LOEP) SV Kit in Patients With Vertebral Compression Fractures (VCFs)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: AgNovos Healthcare, LLC · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

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

Conditions

• Vertebral Compression Fracture
• Vertebral Compression
• Vertebral Fracture

Interventions

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

Timeline

• Start date: 2021-05-19
• Primary completion: 2027-12-01
• Completion: 2028-12-01
• First posted: 2021-03-30
• Last updated: 2025-03-28

Locations

4 sites across 2 countries: Germany, Spain

Regulatory

• FDA-regulated device study