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Trial record 6 of 8 for:    clear guide medical

Image Guidance for Improved Vessel Cannulation in Pediatric Patients

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: NCT04031495
Recruitment Status : Completed
First Posted : July 24, 2019
Last Update Posted : July 24, 2019
Sponsor:
Collaborator:
Children's National Research Institute
Information provided by (Responsible Party):
Clear Guide Medical

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Central Vein Cannulation Device: central vein cannulation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Image Guidance for Improved Vessel Cannulation in Pediatric Patients
Actual Study Start Date : April 22, 2019
Actual Primary Completion Date : May 10, 2019
Actual Study Completion Date : May 10, 2019

Intervention Details:
  • Device: central vein cannulation
    central vein cannulation


Primary Outcome Measures :
  1. Successful Central Vein Cannulation [ Time Frame: 1 day ]
    device enabled successful cannulation on the first pass showing feasibility to aid in cvcs



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • none

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04031495


Locations
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United States, District of Columbia
Children's National Medical Center
Washington, District of Columbia, United States, 20910
Sponsors and Collaborators
Clear Guide Medical
Children's National Research Institute
Investigators
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Principal Investigator: Karun Sharma, MD Children's National Research Institute
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Responsible Party: Clear Guide Medical
ClinicalTrials.gov Identifier: NCT04031495    
Other Study ID Numbers: 1R44HD096974-01 ( U.S. NIH Grant/Contract )
First Posted: July 24, 2019    Key Record Dates
Last Update Posted: July 24, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes