The Ailliance Post-Market Clinical Study
The Ailliance Post-Market Clinical Study: All enablIng technoLogies, bioLogics, IDS, And Core spiNe produCt collEction
Medtronic Spinal and Biologics
1,000 participants
May 1, 2023
INTERVENTIONAL
Conditions
Summary
The purpose of this clinical study is to collect performance and safety data for post-market Medtronic devices indicated for cranial and/or spinal indication(s). Subjects are enrolled and followed postoperatively to 24 months. The Ailliance clinical study is intended to collect data congruous with routine clinical care practices.
Eligibility
Inclusion Criteria4
- Subject provides written informed consent per institution and/or geographical requirements.
- Subject is intended to receive or be treated with an eligible Medtronic Cranial and Spinal Technology (CST) device(s) (see product appendices), used alone or in combination, for a cranial and/or spinal indication(s).
- Subject is at least 18 years of age or minimum legal age as required by local regulations.
- Subject agrees to complete all required assessments per the Schedule of Events.
Exclusion Criteria3
- Subject is currently enrolled or plans to enroll in concurrent drug/device/biologic trial(s) that may confound this trial's results per investigator assessment (i.e. no required intervention that could affect interpretation of all-around device safety and or performance).
- Subject who is, or is expected to be, inaccessible for all required follow-up visits.
- Subject is considered vulnerable at the time of obtaining consent.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Follow-up assessments will be required (therefore interventional) from pre-operative baseline to 24 months post index surgery
Locations(24)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05856370