Recruiting

Ultrasound-guided Cannulations

Sponsor:

Clear Guide Medical

Code:

NCT04039490

Conditions

Clinical Procedures Which Require Vessel Cannulations in Pediatric Patients

Eligibility Criteria

Sex: All

Age: 0 - 17

Healthy Volunteers: Not accepted

Interventions

SCENERGY

Study Details

Brief summary:

Clinical Trial to investigate whether the use of a novel device to be used in conjunction with ultrasound in pediatric vessel cannulations is superior to ultrasound-only pediatric vessel cannulations in terms of number of cannulation attempts.

Conditions

Clinical Procedures Which Require Vessel Cannulations in Pediatric Patients

Study ID

NCT04039490

Start date

Feb 6, 2024

Status verified date

Sep, 2024

Completion date

Aug 31, 2025

Anticipated

Primary completion date

Aug 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 17

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • any pediatric patient scheduled for a vessel cannulation at CNMC

Exclusion Criteria:

  • none

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

no intervention: Ultrasound-only Pediatric Vessel Cannulation

The standard of care for vessel cannulation currently employed at CNMC

experimental: SCENERGY-guided Pediatric Vessel Cannulation

The addition of the SCENERGY guidance combined with the ultrasound for pediatric vessel cannulations.

Interventions

SCENERGY

Use of the SCENERGY guidance device in conjunction with ultrasound to guide needles for pediatric vessel cannulations

Primary outcome measure

  • Successful first-attempt vessel cannulation [ Time Frame: 1 hour ]

Central Contacts and Locations

Central contacts

Dorothee Heisenberg, PhD

4435703835heisenberg@clearguidemedical.com

Kevin Cleary, PhD

202-476-3809KCleary@childrensnational.org

Locations

Children's National Medical Center

Recruiting

Washington, District of Columbia, United States, 20910

Contacts

Karun Sharma, MD

301-565-8447OPHS@childrensnational.org

More Information

Sponsor

Clear Guide Medical

Last update posted

Sep 26, 2024

Last verified

Sep, 2024

Keywords

  • pediatrics
  • vessel cannulations
  • ultrasound-guided

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Clear Guide Medical on 2024-09-26.