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UnknownNCT03180749

Post-Marketing Clinical Follow-Up of a Spine Implant

Post-Marketing Clinical Follow-up of an Anular Closure System (Barricaid®) to Confirm Comparability of Outcome Between Devices With Subcomponents From Two Different Suppliers

Status
Unknown
Phase
Study type
Observational
Enrollment
90 (actual)
Sponsor
Intrinsic Therapeutics · Industry
Sex
All
Age
18 Years
Healthy volunteers
Accepted

Summary

Post-Marketing Clinical Follow-up of an Anular Closure System (Barricaid®) to Confirm Comparability of Outcome between Devices with Subcomponents from Two Different Suppliers

Detailed description

Comparison of device integrity (anchor fracture and/or mesh detachment) and device movement/migration in patients implanted with the Barricaids with anchors from two different suppliers.

Conditions

Interventions

TypeNameDescription
OTHERFollow up per standard of carePatients will come in 2 years post implantation and receive standard examinations

Timeline

Start date
2017-03-02
Primary completion
2024-06-01
Completion
2024-09-01
First posted
2017-06-08
Last updated
2023-09-28

Locations

6 sites across 2 countries: Germany, Switzerland

Source: ClinicalTrials.gov record NCT03180749. Inclusion in this directory is not an endorsement.

Post-Marketing Clinical Follow-Up of a Spine Implant (NCT03180749) · Clinical Trials Directory