Tumors (Others)NCT07783698
Cook iMRI Needles NSR Clinical Study
An observational study of Tumors (Others) and Viscera, run by Cook Research Incorporated at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tumors (Others), Viscera, Masses
- What is being tested?
- Percutaneous non-vascular access to anatomic structures
- Type of treatment
- Medical device
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jan 2026to 2 Jun 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Clinically appropriate patients who can willing participate in research.
Who may be able to join
- Patient is suitable for inclusion in the study if the patient meets the following criteria:
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Medicine
Ann Arbor, Michigan, 48109
About this study
Official title: 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.
- Conditions
- Tumors (Others), Viscera, Masses
- Being tested
- Percutaneous non-vascular access to anatomic structures
- Keywords
- Biopsy, Needle, Magnetic Resonance Imaging
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous non-vascular access to anatomic structuresDevice
During MRI procedure, a Cook® iMRI Needle will be used instead of the standard of care needle.
| Study group | Role | What they receive |
|---|---|---|
| Patient Cohort | Not described Receives: Device: Percutaneous non-vascular access to anatomic structures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of successful needle introduction
Successful percutaneous needle introduction into the target anatomy.
Measured: Duration of procedure (approximately 1 hour)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2026
- Study start6 Jan 2026
- Primary completion2 Jun 2026
- Study completion2 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tumors (Others)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cook Research Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Vikas Gulani, MD,PhD, Principal investigator, University of Michigan Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07783698
- Sponsor's protocol ID
- 25-06
- Status last verified
- Aug 2026
- First submitted
- 21 Aug 2026
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cook® iMRI Needles Non-Significant Risk Clinical Study
- ClinicalTrials.gov ID
- NCT07783698
- Acronym / sponsor ID
- 25-06
- Conditions
- Tumors (Others), Viscera, Masses
- Keywords
- Biopsy, Needle, Magnetic Resonance Imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Cook Research IncorporatedIndustry (pharma, biotech, devices)
- Study start
- 6 Jan 2026 (actual)
- Primary completion
- 2 Jun 2026 (actual)
- Study completion
- 2 Jun 2026 (actual)
- First posted
- 25 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient Cohort | – | Device: Percutaneous non-vascular access to anatomic structures |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Clinically appropriate patients who can willing participate in research.
Key inclusion criteria (4 listed)
- Patient is suitable for inclusion in the study if the patient meets the following criteria:
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneous non-vascular access to anatomic structuresDuring MRI procedure, a Cook® iMRI Needle will be used instead of the standard of care needle. | Device | Patient Cohort |
Primary outcome
Rate of successful needle introduction
Time frame: Duration of procedure (approximately 1 hour)
Successful percutaneous needle introduction into the target anatomy.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vikas Gulani, MD,PhD principal investigator
University of Michigan Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tumors (Others) and Viscera, run by Cook Research Incorporated at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of successful needle introduction (time frame: Duration of procedure (approximately 1 hour)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.