The Ailliance Post-Market Clinical Study: All enablIng technoLogies,bioLogics, IDS, And core spiNe produCt collEction
D
David Stockwell
Primary Investigator
Enrolling By Invitation
18-100 years
All
Phase
N/A
25 participants needed
2 Locations
Brief description of study
What is this study about?
.This clinical study is being conducted to collect clinical evidence on treatment(s) with CST Medtronic products which will assess specific performance and safety endpoints
THIS STUDY IS ENROLLING BY INVITATION ONLY - Only subjects intended to receive or be treated with an eligible Medtronic CST device(s) in the local geography (device list located in the product group appendices) and who meet eligibility criteria, may be enrolled into the Ailliance study .This is a post-market study to collect performance and safety data for Medtronic devices (indicated for cranial and/or spinal indications). The surgeries are Standard of Care (SOC) and the follow up visits, in general, should align with the SOC clinic visits but sites are required to follow protocol schedule of events.
Detailed description of study
The following is a list that outlines all the potential timepoints. The specific visits to be completed are dependent on the product group, as follows:
• Preoperative baseline visit
• Index surgery
• Discharge
• 1-month postoperative visit (30 ± 7 days)
• 3-month postoperative visit (91± 14 days) (optional visit per the
discretion of the investigator)
• 6-month postoperative visit (182 ± 30 days)
• 12-month postoperative visit (365 ± 91 days)
• 24-month (730 ± 91 days)
• Preoperative baseline visit
• Index surgery
• Discharge
• 1-month postoperative visit (30 ± 7 days)
• 3-month postoperative visit (91± 14 days) (optional visit per the
discretion of the investigator)
• 6-month postoperative visit (182 ± 30 days)
• 12-month postoperative visit (365 ± 91 days)
• 24-month (730 ± 91 days)
The expected duration of the study for each subject is up to 24 months (730 ± 91 days).
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: cranial, spinal
-
Age: Between 18 Years - 100 Years
-
Gender: All
Inclusion criteria:
- Subject is intended to receive or be treated with an eligible Medtronic CST device(s), used alone or in combination, for a cranial and/or spinal indication(s).
- 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 with exclusion criteria required by local law.
- Subject is considered vulnerable at the time of obtaining consent
Updated on
01 Aug 2024.
Study ID: SNEU-MEDTRONIC-AILLIANCE, 20126
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