NCT05170815

Clariance ErYs Registry

Clariance Registry of ERISMA® and Idys® Devices

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 760 (estimated)
• Sponsor: Clariance · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

International, prospective, single arm, multicenter and observational Post-Market Clinical Follow-up (PMCF). The overall objective of this study is to collect preoperative, intraoperative and postoperative (at 9 weeks, 6 months, 1 year and 2 years) data on the clinical complications and functional outcomes of the study devices to demonstrate safety and performance in a real-world setting. The primary objective is to demonstrate that the use of the study devices is safe. The secondary objective is to demonstrate that the use of the study devices decreases the pain, and improves the quality of life and the daily activities of the subjects.

Conditions

• Spine Degeneration
• Spine Spondylosis Thoracic
• Spinal Deformity
• Spinal Tumor
• Spinal Fracture

Interventions

Type	Name	Description
PROCEDURE	Spine surgery	Implantation of spine Interbody Fusion Devices and/or Posterior fixation System.

Timeline

• Start date: 2022-01-17
• Primary completion: 2028-12-01
• Completion: 2028-12-01
• First posted: 2021-12-28
• Last updated: 2026-03-17

Locations

1 site across 1 country: France

Regulatory

• FDA-regulated device study