ClinicalTrials.gg
CompletedNCT07783698Updated Aug 28, 2026

Cook iMRI Needles NSR Clinical Study

An observational study in Tumors (Others), Viscera and Masses, sponsored by Cook Research Incorporated. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-28.

Sponsored by Cook Research Incorporated (part of Cook Group Incorporated) · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
10
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Tumors (Others)
  • Viscera
  • Masses

Browse trials for

Keywords

  • Biopsy
  • Needle
  • Magnetic Resonance Imaging
03

In context

Neoplasms

10,818 studies on the registry are indexed under Neoplasms; 2,324 are open to participants now.

This study's enrollment of 10 is below the median of 200 across 2,638 observational studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

Cook Research Incorporated is the lead sponsor of 33 studies on the registry; 4 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 5 (83%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Clinically appropriate patients who can willing participate in research.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  1. Inability or refusal to give 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 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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
10 participants (actual)
Patient registry
No

Groups and cohorts

  • Patient Cohort

    Device: Percutaneous non-vascular access to anatomic structures

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.

06

What researchers measure

Primary outcomes

  1. Rate of successful needle introduction

    Successful percutaneous needle introduction into the target anatomy.

    Time frame: Duration of procedure (approximately 1 hour)

07

Study locations

1 site
  • University of Michigan Medicine
    Ann Arbor, Michigan 48109, United States
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2026 to primary completion in Jun 2026, 4 months.

Of 148 industry-sponsored observational studies under Neoplasms, half reached primary completion within 47 months of starting (the median), counting those still running; a quarter within 29 and three quarters within 102. This study's 4 months is below that.

Counting every sponsor, half of 1,246 studies reached it within 58 months; a quarter within 24 and three quarters within 210.

Neoplasms covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 21, 2026
First posted
Aug 25, 2026
StartActual
Jan 6, 2026
Primary completionActual
Jun 2, 2026
CompletionActual
Jun 2, 2026
Last update
Aug 28, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 28, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07783698
Responsible party
Sponsor
First posted
Aug 25, 2026
Start date
Jan 6, 2026
Primary completion
Jun 2, 2026
Completion
Jun 2, 2026
Last update
Aug 28, 2026

Study contacts

Vikas Gulani, MD,PhD
principal investigator · University of Michigan Medicine

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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