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

• ClinicalTrials.gov Identifier: NCT03232385
• Recruitment Status: Withdrawn
• First Posted: July 28, 2017
• Last Update Posted: July 28, 2017
• Sponsor: Clear Guide Medical
• Collaborator: University of Maryland
• Information provided by (Responsible Party): Clear Guide Medical

Tracking Information

• First Submitted Date: July 12, 2016
• First Posted Date: July 28, 2017
• Last Update Posted Date: July 28, 2017
• Estimated Study Start Date: April 1, 2018
• Estimated Primary Completion Date: March 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Modality Augmentation for Navigation: Intuitive Fusion With Optical Lightweight Device (US/MR)
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Supportive Care
• Condition: Renal Biopsy or Ablation

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Withdrawn
• Actual Enrollment (submitted: July 25, 2017): 0
• Original Actual Enrollment: Same as current
• Estimated Study Completion Date: March 2019
• Estimated Primary Completion Date: March 2019 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT03232385
• Other Study ID Numbers: 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

• Plan to Share IPD: No

• Current Responsible Party: Clear Guide Medical
• Original Responsible Party: Same as current
• Current Study Sponsor: Clear Guide Medical
• Original Study Sponsor: Same as current
• Collaborators: University of Maryland
• Investigators: Not Provided
• PRS Account: Clear Guide Medical
• Verification Date: July 2017