MANIFOLD II: Modality Augmentation for Navigation: Intuitive Fusion With Optical Lightweight Device (US/CBCT)
Study Details
Study Description
Brief Summary
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.
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
Detailed Description
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: CBCT-US Fusion Arm Clear Guide SCENERGY, CBCT-US |
Device: CBCT-US Fusion Arm
Use of Clear Guide SCENERGY for CBCT-US fusion guidance
Other Names:
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Active Comparator: EM Fusion or No Fusion Arm
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Procedure: Hepatic Biopsy or Ablation
Standard of Care
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Outcome Measures
Primary Outcome Measures
- Success of needle placement [Immediately following intervention (within 2 hours)]
Distance between needle tip and target
Eligibility Criteria
Criteria
Inclusion Criteria:
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Undergoing radiological, oncological, or urological intervention procedures
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Able to give written informed consent
Exclusion Criteria:
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Unable to give informed consent
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Vulnerable populations and children
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Clear Guide Medical
- Johns Hopkins University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CGM 18-002