Image Guidance for Improved Vessel Cannulation in Pediatric Patients
1 other identifier
interventional
4
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2019
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 17, 2019
CompletedStudy Start
First participant enrolled
April 22, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 10, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 10, 2019
CompletedFirst Posted
Study publicly available on registry
July 24, 2019
CompletedJuly 24, 2019
July 1, 2019
18 days
April 17, 2019
July 22, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Successful Central Vein Cannulation
device enabled successful cannulation on the first pass showing feasibility to aid in cvcs
1 day
Interventions
central vein cannulation
Eligibility Criteria
You may qualify if:
- pediatric patients of weight between 5 and 25 kg requiring a central vein cannulation
You may not qualify if:
- none
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Clear Guide Medicallead
- Children's National Research Institutecollaborator
Study Sites (1)
Children's National Medical Center
Washington D.C., District of Columbia, 20910, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Karun Sharma, MD
Children's National Research Institute
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DEVICE FEASIBILITY
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 17, 2019
First Posted
July 24, 2019
Study Start
April 22, 2019
Primary Completion
May 10, 2019
Study Completion
May 10, 2019
Last Updated
July 24, 2019
Record last verified: 2019-07
Data Sharing
- IPD Sharing
- Will not share