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

NCT ID: NCT03231046

Last Updated: 2017-07-27

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-01
• Study Completion Date: 2019-03-31

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.

Conditions

Hepatic Biopsy or Ablation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

CBCT-US Fusion Arm

Clear Guide SCENERGY, CBCT-US

Group Type: EXPERIMENTAL

CBCT-US Fusion Arm

Intervention Type: DEVICE

Use of Clear Guide SCENERGY for CBCT-US fusion guidance

EM Fusion or No Fusion Arm

Group Type: ACTIVE_COMPARATOR

Hepatic Biopsy or Ablation

Intervention Type: PROCEDURE

Standard of Care

Interventions

CBCT-US Fusion Arm

Use of Clear Guide SCENERGY for CBCT-US fusion guidance

Intervention Type: DEVICE

Hepatic Biopsy or Ablation

Standard of Care

Intervention Type: PROCEDURE

Other Intervention Names

Clear Guide SCENERGY, CBCT-US

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johns Hopkins University

OTHER

Sponsor Role: collaborator

Clear Guide Medical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

CGM 18-002

Identifier Type: -

Identifier Source: org_study_id