Image Guidance for Improved Vessel Cannulation in Pediatric Patients

July 2, 2026 updated by: Clear Guide Medical
Feasibility Study This will be performed by an expert operator in Interventional Radiology who routinely performs CVC catheter placement, using appropriate pediatric human anatomy and vessel size, as well as real patient care scenarios.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Phase I Feasibility Study This will be performed by an expert operator in Interventional Radiology who routinely performs CVC catheter placement, using appropriate pediatric human anatomy and vessel size, as well as real patient care scenarios. n=5 patients will be enrolled, and success would be 4 children (80%) successfully cannulated with a single pass using the P-SCENERGY.

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20910
        • Children's National Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 17 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • pediatric patients of weight between 5 and 25 kg requiring a central vein cannulation

Exclusion Criteria:

  • none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Central Vein Cannulation using Clear Guide SCENERGY system
The Clear Guide navigation system will be used for central venous catheter (CVC) placement in pediatric patients. This is a single site pilot/feasibility study. We will test the feasibility of using this system in pediatric patients who are undergoing CVC placement by the Interventional Radiology team in the operating room as part of their routine clinical care.
Device: Central Vein Cannulation
Central Vein Cannulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Successful Central Vein Cannulation
Time Frame: 1 day
device enabled successful cannulation on the first pass showing feasibility to aid in cvcs
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clear Guide Medical

Collaborators

Children's National Research Institute

Investigators

  • Principal Investigator: Karun Sharma, MD, Children's National Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 22, 2019

Primary Completion (Actual)

May 10, 2019

Study Completion (Actual)

May 10, 2019

Study Registration Dates

First Submitted

April 17, 2019

First Submitted That Met QC Criteria

July 22, 2019

First Posted (Actual)

July 24, 2019

Study Record Updates

Last Update Posted (Actual)

July 30, 2026

Last Update Submitted That Met QC Criteria

July 2, 2026

Last Verified

July 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • 1R44HD096974-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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