This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

NICU-TECH RM9L-RS Probe ME Feasibility Study

This study has been completed.
Information provided by (Responsible Party):
GE Healthcare Identifier:
First received: August 12, 2010
Last updated: February 9, 2012
Last verified: January 2012
Use of a new ultrasound device designed for babies to look at the catheters in veins and arteries as well as the blood vessel itself. An observational study to assess the the clinicians perception of the ultrasound image quality as a tool to detect catheters in vessels.

Condition Intervention Phase
Neonates Device: ultrasound probing Phase 1 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: NICU-TECH RM9L-RS Probe ME Feasibility Study

Further study details as provided by GE Healthcare:

Primary Outcome Measures:
  • Determine the feasibility of the RM9L-RS US probe and catherter placement [ Time Frame: 6 months ]
    Determine the feasibility of the RM9L-RS ultrasound probe current design yeilds depth of penetration that is satisfactory for seeing catherter in peripheral vessels and catheter tips in central vessels.

Enrollment: 32
Study Start Date: June 2010
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: ultrasound probing
    Ultrasound probing and imaging data collection.
Detailed Description:
The intent of the study is to confirm the maximum penetration of the NICU-Tech RM9L-RS probe. The investigators will endeavor to collect images on patients with PIV (Peripheral Intra Venous)/PAC (Peripheral Arterial Catheter) and central line catheters. The investigators will also endeavor to collect images of deep vessel structures for offline processing to improve NICU-Tech algorithms for vessel segmentation.

Ages Eligible for Study:   23 Weeks to 6 Months   (Child)
Sexes Eligible for Study:   All

Inclusion Criteria:

  • Neonates that are 23 gestational weeks at birth (and greater than 500 grams) to a 6 month old born infant at term (maximum weight 7 kg) who already have one or more lines placed (PIV/PAC/UVC/UACs/PICC) as part of their medical care. NO INFANT WILL HAVE A LINE PLACE FOR THE PURPOSE OF THIS STUDY

Exclusion Criteria:

  • Neonates that are less than 23 gestational weeks at birth
  • Neonates that are 23 gestational weeks at birth but are less than 500 grams in weight
  • Patients weighing more than 7 kg.-Patients older than 6 months
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01181596

United States, California
UCSD Medical Center
San Diego, California, United States, 92103
Sponsors and Collaborators
GE Healthcare
Principal Investigator: Jae Kim, MD UCSD Medical Center
  More Information

Responsible Party: GE Healthcare Identifier: NCT01181596     History of Changes
Other Study ID Numbers: NICU-TECH RM9L-RS
Study First Received: August 12, 2010
Last Updated: February 9, 2012

Keywords provided by GE Healthcare:
neonates and infants, from the 23-week gestational (0.5 kg)
up to a 6 month old born at term (7 kg), for whom the PIV,
PAC, UAC, UVC or PICC catheter insertion is medically
indicated. processed this record on June 23, 2017