ClinicalTrials.gov

History of Changes for Study: NCT03232385
Modality Augmentation for Navigation: Intuitive Fusion With Optical Lightweight Device (US/MR) (MANIFOLD I)
Latest version (submitted July 25, 2017) on ClinicalTrials.gov
  • A study version is represented by a row in the table.
  • Select two study versions to compare. One each from columns A and B.
  • Choose either the "Merged" or "Side-by-Side" comparison format to specify how the two study versions are to be displayed. The Side-by-Side format only applies to the Protocol section of the study.
  • Click "Compare" to do the comparison and show the differences.
  • Select a version's Submitted Date link to see a rendering of the study for that version.
  • The yellow A/B choices in the table indicate the study versions currently compared below. A yellow table row indicates the study version currently being viewed.
  • Hover over the "Recruitment Status" to see how the study's recruitment status changed.
  • Study edits or deletions are displayed in red.
  • Study additions are displayed in green.
Study Record Versions
Version A B Submitted Date Changes
1 July 25, 2017 None (earliest Version on record)
Comparison Format:

Scroll up to access the controls

Study NCT03232385
Submitted Date:  July 25, 2017 (v1)

Open or close this module Study Identification
Unique Protocol ID: CGM 18-001
Brief Title: Modality Augmentation for Navigation: Intuitive Fusion With Optical Lightweight Device (US/MR) (MANIFOLD I)
Official Title: Modality Augmentation for Navigation: Intuitive Fusion With Optical Lightweight Device (US/MR)
Secondary IDs:
Open or close this module Study Status
Record Verification: July 2017
Overall Status: Withdrawn [Lack of funding]
Study Start: April 1, 2018
Primary Completion: March 2019 [Anticipated]
Study Completion: March 2019 [Anticipated]
First Submitted: July 12, 2016
First Submitted that
Met QC Criteria:
July 25, 2017
First Posted: July 28, 2017 [Actual]
Last Update Submitted that
Met QC Criteria:
July 25, 2017
Last Update Posted: July 28, 2017 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Clear Guide Medical
Responsible Party: Sponsor
Collaborators: University of Maryland
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: Yes
Unapproved/Uncleared Device:
Pediatric Postmarket Surveillance:
Data Monitoring: No
Open or close this module 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.
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.
Open or close this module Conditions
Conditions: Renal Biopsy or Ablation
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Supportive Care
Study Phase: Not Applicable
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 0 [Actual]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Success of Needle Placement
[ Time Frame: Immediately following intervention (within 2 hours) ]

Distance between needle position and target
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
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
Open or close this module Contacts/Locations
Locations:
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations:
Links:
Available IPD/Information:

Scroll up to access the controls Scroll to the Study top

U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services