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Trial record 1 of 8 for:    clear guide medical
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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.
 
ClinicalTrials.gov Identifier: NCT03232385
Recruitment Status : Withdrawn (Lack of funding)
First Posted : July 28, 2017
Last Update Posted : July 28, 2017
Sponsor:
Collaborator:
University of Maryland
Information provided by (Responsible Party):
Clear Guide Medical

Tracking Information
First Submitted Date  ICMJE July 12, 2016
First Posted Date  ICMJE July 28, 2017
Last Update Posted Date July 28, 2017
Estimated Study Start Date  ICMJE April 1, 2018
Estimated Primary Completion Date March 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 25, 2017)
Success of Needle Placement [ Time Frame: Immediately following intervention (within 2 hours) ]
Distance between needle position and target
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Modality Augmentation for Navigation: Intuitive Fusion With Optical Lightweight Device (US/MR)
Official Title  ICMJE Modality Augmentation for Navigation: Intuitive Fusion With Optical Lightweight Device (US/MR)
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Renal Biopsy or Ablation
Intervention  ICMJE
  • Device: MR-US Fusion Arm
    Use of Clear Guide SCENERGY for MR-US fusion guidance
    Other Name: Clear Guide SCENERGY, MR-US
  • Procedure: Renal Biopsy or Ablation
    Standard of Care
Study Arms  ICMJE
  • Experimental: MR-US Fusion Arm
    Clear Guide SCENERGY, MR-US
    Intervention: Device: MR-US Fusion Arm
  • Active Comparator: EM Fusion or No Fusion Arm
    Intervention: Procedure: Renal Biopsy or Ablation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: July 25, 2017)
0
Original Actual Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2019
Estimated Primary Completion Date March 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03232385
Other Study ID Numbers  ICMJE CGM 18-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Clear Guide Medical
Study Sponsor  ICMJE Clear Guide Medical
Collaborators  ICMJE University of Maryland
Investigators  ICMJE Not Provided
PRS Account Clear Guide Medical
Verification Date July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP