NeonatesNCT01181596
NICU-TECH RM9L-RS Probe ME Feasibility Study
An observational study of Neonates, run by GE Healthcare at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 23 weeks to 6 months
- Conditions the study is for
- Neonates
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2010to Nov 2011
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 23 weeks to 6 months
- All sexes
- No healthy volunteers
- Child
Study population: 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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
The intent of the study is to confirm the maximum penetration of the NICU-Tech RM9L-RS probe. The investigators collected images on patients with PIV (Peripheral Intra Venous)/PAC (Peripheral Arterial Catheter) and central line catheters. The investigators collected images of deep vessel structures for offline processing to improve NICU-Tech algorithms for vessel segmentation.
- Conditions
- Neonates
- Keywords
- 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.
- Medical subject headings
- Atrial Premature Complexes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: observational ultrasound | Collection of image data with the ultrasound probe. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants That Fulfilled All Study Procedures.
Acquisition of basic images and video were obtained from study participants who already have one or more catheters in place.
Measured: 1 day (day of procedure)
Vessel Penetration of NICU-Tech RM9L-RS Probe
The algorithmic depth of vessel penetration will be collected.
Measured: 1 day (day of procedure)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2010 (estimated)
- Study startJun 2010
- Primary completionNov 2011
- Study completionNov 2011
Why it stopped: Images not adequate to visualize catheter penetration or obtain measurements
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for NeonatesStudies of the same condition, open and under way.
- More trials run by GE HealthcareThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- GE Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jae Kim, MD, Principal investigator, UCSD Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01181596
- Sponsor's protocol ID
- NICU-TECH RM9L-RS
- Status last verified
- Jun 2019
- First submitted
- 12 Aug 2010
- Last updated
- 6 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NICU-TECH RM9L-RS Probe ME Feasibility Study
- ClinicalTrials.gov ID
- NCT01181596
- Acronym / sponsor ID
- NICU-TECH RM9L-RS
- Conditions
- Neonates
- Keywords
- 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.
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Images not adequate to visualize catheter penetration or obtain measurements
- Enrolment
- 31 participants (actual)
- Lead sponsor
- GE HealthcareIndustry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 13 Aug 2010 (estimated)
- Results
- Posted 6 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The intent of the study is to confirm the maximum penetration of the NICU-Tech RM9L-RS probe. The investigators collected images on patients with PIV (Peripheral Intra Venous)/PAC (Peripheral Arterial Catheter) and central line catheters. The investigators collected images of deep vessel structures for offline processing to improve NICU-Tech algorithms for vessel segmentation.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1: observational ultrasound | – | –Collection of image data with the ultrasound probe. |
Who may qualify
- Ages
- 23 weeks to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- 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.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jae Kim, MD principal investigator
UCSD Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neonates, run by GE Healthcare at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participants That Fulfilled All Study Procedures. (time frame: 1 day (day of procedure)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2019.