Cook iMRI Needles NSR Clinical Study

NCT07783698 | Completed FDA Device

• 1 other identifier: 25-06
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Tumors (Others); Viscera; Masses

Keywords

Biopsy; Needle; Magnetic Resonance Imaging

Outcome Measures

Primary Outcomes (1)

• Rate of successful needle introduction

  Successful percutaneous needle introduction into the target anatomy.

  Duration of procedure (approximately 1 hour)

Study Arms (1)

Patient Cohort

Device: Percutaneous non-vascular access to anatomic structures

Interventions

Percutaneous non-vascular access to anatomic structures DEVICE

During MRI procedure, a Cook® iMRI Needle will be used instead of the standard of care needle.

Patient Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Clinically appropriate patients who can willing participate in research.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Cook Research Incorporated: lead

Study Sites (1)

University of Michigan Medicine

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Vikas Gulani, MD,PhD

  University of Michigan Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2026
• First Posted: August 25, 2026
• Study Start: January 6, 2026
• Primary Completion: June 2, 2026
• Study Completion: June 2, 2026
• Last Updated: August 28, 2026

Record last verified: 2026-08

Locations

US (1)