Clinical trial · Observational
Clariance ErYs Registry
Clariance Registry of ERISMA® and Idys® Devices
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Spinal Deformity | — | UNRESOLVED | — |
| Spinal Fracture | — | UNRESOLVED | — |
| Spinal Tumor | — | UNRESOLVED | — |
| Spine Degeneration | — | UNRESOLVED | — |
| Spine Spondylosis Thoracic | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Spine surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (11)
- label
- ERISMA® LP/LP EVO
- description
- 120 subjects with ERISMA® LP/LP EVO implant
- interventionNames
- Procedure: Spine surgery
- label
- ERISMA® Deformity
- description
- 120 subjects with ERISMA® Deformity implant
- interventionNames
- Procedure: Spine surgery
- label
- ERISMA® MIS
- description
- 120 subjects with ERISMA® MIS implant
- interventionNames
- Procedure: Spine surgery
- label
- Idys® TLIF PEEK
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Considered as adult in the respective geography (18 years old or older for France and 21 years old or older for United-States). * Indicated for treatment with one or more commercially available sponsor spine device included into the study. * For France only, affiliated with or beneficiary of a social security scheme. Exclusion Criteria: * Subjects who are not able to comply with the study procedures based on the judgment of the investigator (e.g., inability to comprehend study related questions, inability to keep scheduled assessment times). * Subjects who are considered as vulnerable: minor, pregnant woman or people under legal protection (guardianship or curatorship). * Contraindicated for spine surgery utilizing a commercially available sponsor spine device.
References
Publications (0)
Data not yet available