NCT03232385

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2018

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 12, 2016

Completed
1 year until next milestone

First Posted

Study publicly available on registry

July 28, 2017

Completed
8 months until next milestone

Study Start

First participant enrolled

April 1, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

July 28, 2017

Status Verified

July 1, 2017

Enrollment Period

11 months

First QC Date

July 12, 2016

Last Update Submit

July 25, 2017

Conditions

Renal Biopsy or Ablation

Outcome Measures

Primary Outcomes (1)

  • Success of Needle Placement

    Distance between needle position and target

    Immediately following intervention (within 2 hours)

Study Arms (2)

MR-US Fusion Arm

EXPERIMENTAL

Clear Guide SCENERGY, MR-US

Device: MR-US Fusion Arm

EM Fusion or No Fusion Arm

ACTIVE COMPARATOR
Procedure: Renal Biopsy or Ablation

Interventions

MR-US Fusion ArmDEVICE

Use of Clear Guide SCENERGY for MR-US fusion guidance

Also known as: Clear Guide SCENERGY, MR-US
MR-US Fusion Arm
Renal Biopsy or AblationPROCEDURE

Standard of Care

EM Fusion or No Fusion Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Undergoing radiological, oncological, or urological intervention procedures
  • Able to give written informed consent

You may not qualify if:

  • Unable to give informed consent
  • Vulnerable populations and children

Contact the study team to confirm eligibility.

Sponsors & Collaborators

0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 12, 2016

First Posted

July 28, 2017

Study Start

April 1, 2018

Primary Completion

March 1, 2019

Study Completion

March 1, 2019

Last Updated

July 28, 2017

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will not share