Clariance ErYs Registry

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05170815
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Clariance
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	France
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Spine Degeneration, Spine Spondylosis Thoracic, Spinal Deformity, Spinal Tumor, Spinal Fracture

Arms & Interventions

Arms

: ERISMA® LP/LP EVO

120 subjects with ERISMA® LP/LP EVO implant

: ERISMA® Deformity

120 subjects with ERISMA® Deformity implant

: ERISMA® MIS

120 subjects with ERISMA® MIS implant

: Idys® TLIF PEEK

50 subjects with Idys® TLIF PEEK implant

: Idys® TLIF TiVAC

50 subjects with Idys® TLIF TiVAC implant

: Idys® TLIF 3DTi

50 subjects with Idys® TLIF 3DTi implant

: Idys® ALIF PEEK

50 subjects with Idys® ALIF PEEK implant

: Idys® ALIF TiVAC

50 subjects with Idys® ALIF TiVAC implant

: Idys® ALIF 3DTi

50 subjects with Idys® ALIF 3DTi implant

: Idys® ALIF ZP 3DTi

50 subjects with Idys® ALIF ZP 3DTi implant

: Idys® LLIF 3DTi

50 subjects with Idys® LLIF 3DTi implant

Interventions

Procedure: - Spine surgery

Implantation of spine Interbody Fusion Devices and/or Posterior fixation System.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.