Cook iMRI Needles NSR Clinical Study

Cook® iMRI Needles Non-Significant Risk Clinical Study

The purpose of this study is to evaluate the safety and performance of the Cook® iMRI Needle. This is an investigational needle that physicians can use to gain access to a particular part of the body, take a small sample of tissue, or inject fluid into a particular part of the body.

Inclusion Criteria:

Patient is suitable for inclusion in the study if the patient meets the following criteria:

1. A qualified physician directs the patient to have a procedure that requires a needle

   for percutaneous access, aspiration, and/or injection during therapeutic or diagnostic interventional MRI-guided procedures

2. Patients, or their legally authorized representatives, must also voluntarily consent to participate in the study

Exclusion Criteria:

1. Inability or refusal to give informed consent by the patient or legally authorized representative
2. Age < 18 years
3. Vulnerable population (specifically prisoners, lactating women and/or cognitively impaired patients)
4. Patients lacking a safe trajectory to the target tissue, as determined by the physician
5. Patients with uncorrectable coagulopathy
6. Allergy to the device or contrast media that cannot be adequately premedicated
7. Body habitus or medical condition that compromises or prevents necessary imaging procedures
8. Body weight exceeding limits of available MRI machines
9. Target lesion is unable to be reached by the longest needle (or in combination with a core biopsy device)
10. Implanted non-MR conditional device or other metallic device (e.g., certain pacemakers, aneurysm clips, cochlear implants, and/or mechanical heart valves)
11. Inability of the patient to cooperate with, or to be positioned for, the procedure