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NICU-TECH RM9L-RS Probe ME Feasibility Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01181596
First Posted: August 13, 2010
Last Update Posted: October 12, 2017
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.
Information provided by (Responsible Party):
GE Healthcare
  Purpose
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: None (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.
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

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
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): NCT01181596


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

Responsible Party: GE Healthcare
ClinicalTrials.gov Identifier: NCT01181596     History of Changes
Other Study ID Numbers: NICU-TECH RM9L-RS
First Submitted: August 12, 2010
First Posted: August 13, 2010
Last Update Posted: October 12, 2017
Last Verified: January 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.