Product Surveillance Registry; Ear, Nose & Throat - NIM Vital Cohort

Launched by MEDTRONIC · Oct 9, 2024

Keywords

ClinConnect Summary

The Product Surveillance Registry for the NIM Vital Cohort is a clinical trial designed to ensure that Medtronic's NIM Vital™ System and its accessories are safe and work well in real-life situations when used for various types of surgeries, including those on the brain, neck, spine, and extremities. The study is currently recruiting participants aged 65 and older who are either already using or are expected to use a Medtronic product as part of their treatment.

To join the study, patients or their authorized representatives must give their permission and meet certain criteria, such as being able to attend follow-up appointments. Participants can expect to have their experiences recorded to help evaluate the system’s performance and safety. It's important to note that individuals who are involved in other similar studies or cannot be easily contacted for follow-up may not be eligible to participate. This trial is an opportunity to contribute to improving medical devices used in surgery, which can benefit future patients.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patient or legally authorized representative (LAR) provides authorization and/or consent per institution and geographical requirements.
• • Patient has or is intended to receive or be treated with an eligible Medtronic product
• • Patient is consented within the enrollment window of the therapy received, as applicable
• Exclusion Criteria:
• • Patient who is, or is expected to be, inaccessible for follow-up
• • Participation is excluded by local law
• • Patient is currently enrolled or plans to enroll in concurrent drug/device study that may confound the PSR results