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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03232385
Recruitment Status : Withdrawn (Lack of funding)
First Posted : July 28, 2017
Last Update Posted : July 28, 2017
University of Maryland
Information provided by (Responsible Party):
Clear Guide Medical

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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)
Estimated Study Start Date : April 1, 2018
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Arm Intervention/treatment
Experimental: MR-US Fusion Arm
Device: MR-US Fusion Arm
Use of Clear Guide SCENERGY for MR-US fusion guidance
Other Name: Clear Guide SCENERGY, MR-US

Active Comparator: EM Fusion or No Fusion Arm Procedure: Renal Biopsy or Ablation
Standard of Care

Primary Outcome Measures :
  1. Success of Needle Placement [ Time Frame: Immediately following intervention (within 2 hours) ]
    Distance between needle position and target

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Responsible Party: Clear Guide Medical Identifier: NCT03232385    
Other Study ID Numbers: CGM 18-001
First Posted: July 28, 2017    Key Record Dates
Last Update Posted: July 28, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes