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

Not Applicable

Withdrawn

• Conditions: Hepatic Biopsy or Ablation
• Interventions: Device: CBCT-US Fusion Arm; Procedure: Hepatic Biopsy or Ablation

• Registration Number: NCT03231046
• Lead Sponsor: Clear Guide Medical

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.

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 Timeline

• Study First Submitted: 2016-07-12
• Status Verified: 2017-07
• Study First Submitted QC: 2017-07-25
• Last Update Submitted: 2017-07-25
• Study First Posted: 2017-07-27
• Last Update Posted: 2017-07-27
• Study Start: 2018-04-01
• Primary Completion: 2019-03
• Study Completion: 2019-03

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CBCT-US Fusion Arm	CBCT-US Fusion Arm	Clear Guide SCENERGY, CBCT-US
EM Fusion or No Fusion Arm	Hepatic Biopsy or Ablation	-

Primary Outcome Measures

Name	Time	Method
Success of needle placement	Immediately following intervention (within 2 hours)	Distance between needle tip and target