NICU-TECH RM9L-RS Probe ME Feasibility Study
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ClinicalTrials.gov Identifier: NCT01181596 |
Recruitment Status :
Terminated
(Images not adequate to visualize catheter penetration or obtain measurements)
First Posted : August 13, 2010
Results First Posted : August 6, 2019
Last Update Posted : August 6, 2019
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Condition or disease |
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Neonates |
Study Type : | Observational |
Actual Enrollment : | 31 participants |
Observational Model: | Case-Control |
Time Perspective: | Prospective |
Official Title: | NICU-TECH RM9L-RS Probe ME Feasibility Study |
Study Start Date : | June 2010 |
Actual Primary Completion Date : | November 2011 |
Actual Study Completion Date : | November 2011 |
Group/Cohort |
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Arm 1: observational ultrasound
Collection of image data with the ultrasound probe.
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- Participants That Fulfilled All Study Procedures. [ Time Frame: 1 day (day of procedure) ]Acquisition of basic images and video were obtained from study participants who already have one or more catheters in place.
- Vessel Penetration of NICU-Tech RM9L-RS Probe [ Time Frame: 1 day (day of procedure) ]The algorithmic depth of vessel penetration will be collected.

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Ages Eligible for Study: | 23 Weeks to 6 Months (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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

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
United States, California | |
UCSD Medical Center | |
San Diego, California, United States, 92103 |
Principal Investigator: | Jae Kim, MD | UCSD Medical Center |
Responsible Party: | GE Healthcare |
ClinicalTrials.gov Identifier: | NCT01181596 |
Other Study ID Numbers: |
NICU-TECH RM9L-RS |
First Posted: | August 13, 2010 Key Record Dates |
Results First Posted: | August 6, 2019 |
Last Update Posted: | August 6, 2019 |
Last Verified: | June 2019 |
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. |