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Initial Clinical Experience With ClearPoint SmartFrame Array-Aided Stereotactic Procedures.

Brett Sterk1, Birra Taha1, Chris Osswald2

  • 1Department of Neurosurgery, University of Minnesota Medical School, Minneapolis, Minnesota, USA.

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Summary
This summary is machine-generated.

The new ClearPoint SmartFrame Array system enhances stereotactic neurosurgery efficiency and safety. This MRI-compatible system allows for accurate lesion targeting and ablation, with improved procedure times compared to previous models.

Keywords:
Frameless stereotaxyIntraoperative magnetic resonance imagingStereotactic brain biopsyStereotactic laser ablation

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Area of Science:

  • Neurosurgery
  • Medical Devices
  • Image-Guided Therapy

Background:

  • The ClearPoint SmartFrame Array is an MRI-compatible stereotactic system with custom neuro-navigation software.
  • It received FDA clearance for clinical use in January 2021.

Purpose of the Study:

  • To report initial safety data for the SmartFrame Array system.
  • To evaluate user experience with SmartFrame Array-supported stereotactic procedures.

Main Methods:

  • Prospective follow-up of the first 10 consecutive patients undergoing stereotactic procedures with the SmartFrame Array.
  • Comparison of procedural data with the previous SmartFrame XG system.

Main Results:

  • Ten patients underwent stereotactic needle biopsy, stereotactic laser ablation (SLA), or combined procedures.
  • High accuracy (radial error < 2 mm) and diagnostic yield (100%) for biopsies.
  • 100% lesion ablation for SLA procedures with no 30-day morbidity or mortality.
  • Reduced average stereotaxis time (80 min vs. 111.5 min) compared to SmartFrame XG (P < 0.01).

Conclusions:

  • The SmartFrame Array system provides a rigid, compact design for enhanced procedural efficiency, accuracy, and safety.
  • Its design supports multi-trajectory stereotaxis for novel clinical applications.