Masses, Tumors (Others), Viscera
Conditions
Keywords
Biopsy, Needle, Magnetic Resonance Imaging
Brief summary
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.
Interventions
DEVICEPercutaneous non-vascular access to anatomic structures
During MRI procedure, a Cook® iMRI Needle will be used instead of the standard of care needle.
Sponsors
Cook Research Incorporated
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of successful needle introduction | Duration of procedure (approximately 1 hour) | Successful percutaneous needle introduction into the target anatomy. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORVikas Gulani, MD,PhD
University of Michigan Medicine
Outcome results
None listed