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

Hepatic Biopsy or Ablation Clinical Trial

— MANIFOLD II  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03231046
• Other study ID #: CGM 18-002
• Status: Withdrawn
• Phase: N/A
• First received: July 12, 2016
• Last updated: July 25, 2017
• Start date: April 1, 2018
• Est. completion date: March 2019

Study information

• Verified date: July 2017
• Source: Clear Guide Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2019
• Est. primary completion date: March 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hepatic Biopsy or Ablation

Intervention

Device:
• CBCT-US Fusion Arm
Use of Clear Guide SCENERGY for CBCT-US fusion guidance

Procedure:
• Hepatic Biopsy or Ablation
Standard of Care

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Clear Guide Medical	Johns Hopkins University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success of needle placement	Distance between needle tip and target	Immediately following intervention (within 2 hours)