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

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

Detailed Description
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Human subjects are proposed to validate the CBCT-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.

Official Title
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Modality Augmentation for Navigation: Intuitive Fusion With Optical Lightweight Device (US/CBCT)

Conditions
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Hepatic Biopsy or Ablation

Intervention / Treatment
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* Device: CBCT-US Fusion Arm
* Procedure: Hepatic Biopsy or Ablation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CBCT-US Fusion Arm<br>Clear Guide SCENERGY, CBCT-US | Device: CBCT-US Fusion Arm<br>* Use of Clear Guide SCENERGY for CBCT-US fusion guidance<br>* Other names: Clear Guide SCENERGY, CBCT-US;|
| Active Comparator: EM Fusion or No Fusion Arm<br> | Procedure: Hepatic Biopsy or Ablation<br>* Standard of Care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success of needle placement | Distance between needle tip and target | Immediately following intervention (within 2 hours) |