Modality Augmentation for Navigation: Intuitive Fusion With Optical Lightweight Device (US/MR)

Overview

The objective of this research is to evaluate functional validation of the MR-US fusion for the Clear Guide SCENERGY system, as well as to evaluate benefits derived from system performance.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 2019

Detailed Description

Human subjects are proposed to validate the MR-US fusion aspects of the Clear Guide SCENERGY product. For these modalities, Clear Guide Medical will work with the subcontract PI to determine the appropriate clinical procedure to evaluate (1) functional validation of the fusion system and (2) benefits derived from system performance. The selected procedure must be a single-patient interaction (i.e., no follow-up visits). Clinical studies will require approval through the subcontract's IRB. The Clear Guide SCENERGY will be compared to standard clinical practice (either no fusion or an electromagnetic-based fusion system). Clear Guide Medical plans to determine sample size based upon statistical powering for a predetermined clinically-meaningful difference (delta). This delta has not been selected, because this depends on the procedure selected. The anticipated sample size is expected to be around 100 subjects (i.e., 50 per arm), per modality. Blinding will be used, where possible. Clinician-related endpoints cannot be blinded due to obvious equipment differences. Subjects will be placed into treatment group by random. Retention strategies are unnecessary, as there will not be any planned follow-up visits or activities.

Interventions

  • Device: MR-US Fusion Arm
    • Use of Clear Guide SCENERGY for MR-US fusion guidance
  • Procedure: Renal Biopsy or Ablation
    • Standard of Care

Arms, Groups and Cohorts

  • Experimental: MR-US Fusion Arm
    • Clear Guide SCENERGY, MR-US
  • Active Comparator: EM Fusion or No Fusion Arm

Clinical Trial Outcome Measures

Primary Measures

  • Success of Needle Placement
    • Time Frame: Immediately following intervention (within 2 hours)
    • Distance between needle position and target

Participating in This Clinical Trial

Inclusion Criteria

  • Undergoing radiological, oncological, or urological intervention procedures – Able to give written informed consent Exclusion Criteria:

  • Unable to give informed consent – Vulnerable populations and children

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Clear Guide Medical
  • Collaborator
    • University of Maryland
  • Provider of Information About this Clinical Study
    • Sponsor

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