NCT03231046

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Clear Guide Medical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hepatic Biopsy or Ablation

Interventions

Type	Name	Description
DEVICE	CBCT-US Fusion Arm	Use of Clear Guide SCENERGY for CBCT-US fusion guidance
PROCEDURE	Hepatic Biopsy or Ablation	Standard of Care

Timeline

• Start date: 2018-04-01
• Primary completion: 2019-03-01
• Completion: 2019-03-01
• First posted: 2017-07-27
• Last updated: 2017-07-27

Regulatory

• FDA-regulated device study