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

Sponsor

Clear Guide Medical (Industry)

Overall Status

Withdrawn

CT.gov ID

NCT03232385

Collaborator

University of Maryland (Other)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The objective of this research is to evaluate functional validation of the MR-US fusion for the Clear Guide SCENERGY system, as well as to evaluate benefits derived from system performance.

Condition or Disease	Intervention/Treatment	Phase
Renal Biopsy or Ablation	Device: MR-US Fusion Arm Procedure: Renal Biopsy or Ablation	N/A

Detailed Description

Human subjects are proposed to validate the MR-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 Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Anticipated Study Start Date :

Apr 1, 2018

Anticipated Primary Completion Date :

Mar 1, 2019

Anticipated Study Completion Date :

Mar 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: MR-US Fusion Arm Clear Guide SCENERGY, MR-US	Device: MR-US Fusion Arm Use of Clear Guide SCENERGY for MR-US fusion guidance Other Names: Clear Guide SCENERGY, MR-US
Active Comparator: EM Fusion or No Fusion Arm	Procedure: Renal Biopsy or Ablation Standard of Care

Arm

Intervention/Treatment

Experimental: MR-US Fusion Arm

Clear Guide SCENERGY, MR-US

Device: MR-US Fusion Arm

Use of Clear Guide SCENERGY for MR-US fusion guidance

Other Names:

Clear Guide SCENERGY, MR-US

Active Comparator: EM Fusion or No Fusion Arm

Procedure: Renal Biopsy or Ablation

Standard of Care

Outcome Measures

Primary Outcome Measures

Success of Needle Placement [Immediately following intervention (within 2 hours)]
Distance between needle position and target

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Clear Guide Medical
University of Maryland

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Clear Guide Medical

ClinicalTrials.gov Identifier:

NCT03232385

Other Study ID Numbers:

CGM 18-001

First Posted:

Jul 28, 2017

Last Update Posted:

Jul 28, 2017

Last Verified:

Jul 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Yes

Study Results

No Results Posted as of Jul 28, 2017