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

Clear Guide Medical

Status: Withdrawn

Conditions: Hepatic Biopsy or Ablation

Treatments: Device: CBCT-US Fusion Arm; Procedure: Hepatic Biopsy or Ablation

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03231046

CGM 18-002

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

CBCT-US Fusion Arm

Experimental group

Description:

Clear Guide SCENERGY, CBCT-US

Treatment:

Device: CBCT-US Fusion Arm

EM Fusion or No Fusion Arm

Active Comparator group

Treatment:

Procedure: Hepatic Biopsy or Ablation