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NCT04563806 · ClinicalTrials.gov registry record · Early Phase 1
Safety of MRI Compatible Hardware for MRI-based Image Guidance During Spine Surgery
A Early Phase 1 study, sponsored by M.D. Anderson Cancer Center.
- Terminated
- Registry status
- Early Phase 1
- Development phase
- 16
- Enrollment target
NCT04563806: Clinical Trial Early Phase 1 study, sponsored by M.D. Anderson Cancer Center.
NCT04563806 is a Early Phase 1 study that was terminated before completion, run by M.D. Anderson Cancer Center. The registered enrollment target is 16 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04563806, a Early Phase 1 study, was terminated before completion, sponsored by M.D. Anderson Cancer Center.
- TERMINATED
- Registry status
- Early Phase 1
- Development phase
- 16 participants
- Enrollment target
Study Summary
This trial investigates the safety and accuracy of using 2 pieces of hardware (a clamp and a needle) that are able to be used with magnetic resonance imaging (MRI) during spinal surgery. During a standard spinal surgery, a computed tomography (CT) scan is used to help plan the placement of surgical instruments used during the procedure or for needle biopsies. Then, the patient is moved to the MRI. For this study, the patient is able to stay in place as the hardware used in this study is able to work with the MRI. Using MRI compatible hardware may allow for an extra degree of safety and facilitate better surgical workflow.
Primary Outcome
Safety will be assessed as a dichotomous variable. Frequencies and descriptive statistics of the outcomes under study will be performed. 95% confidence intervals will be computed. Other ad-hoc analyses may be performed as well.
Interventions
- PROCEDURE Therapeutic Conventional Surgery
- DEVICE Magnetic Resonance Imaging
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2019-04-18 |
| Est. Completion | 2022-05-19 |
| Phase | Early Phase 1 |
Why NCT04563806 stopped before completion
NCT04563806 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 2 interventions - of which Therapeutic Conventional Surgery is the first listed.
NCT04563806 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04563806 about?
NCT04563806 is a clinical study titled "Safety of MRI Compatible Hardware for MRI-based Image Guidance During Spine Surgery". This trial investigates the safety and accuracy of using 2 pieces of hardware (a clamp and a needle) that are able to be used with magnetic resonance imaging (MRI) during spinal surgery. During a standard spinal surgery, a computed tomography (CT) scan is used to help plan the placement of surgical ...
What is the current status of trial NCT04563806?
This trial is currently terminated. It is a Early Phase 1 study. The enrollment target is 16 participants. The study started on 2019-04-18. Estimated completion is 2022-05-19.
What interventions are being tested in trial NCT04563806?
The interventions under investigation include: Therapeutic Conventional Surgery (PROCEDURE), Magnetic Resonance Imaging (DEVICE).
Who is sponsoring clinical trial NCT04563806?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04563806's enrollment target sits among peer trials
16 1369th of 2000 higher than 598 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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