An interventional study of Single Use Vein Entry Indicator Device in Intravenous Access, sponsored by Mayo Clinic. Terminated at 1 site in United States. Open to participants aged Up to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-23.
Sponsored by Mayo Clinic · Not applicable, Interventional, and Supportive care
The purpose of this study is to determine if use of the SU-VEID™ in children facilitates an increase success rate of peripheral intravenous starts, in comparison to the conventional method of vein entry techniques.
Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.
Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Pediatric patients in surgical pre-op requiring an IV catheter for surgery will have standard IV insertion
Pediatric patients in surgical pre-op requiring an IV catheter for surgery will have IV insertion using SU-VEID device
Device: Single Use Vein Entry Indicator Device
Electronic pressure sensing device, integrated to a conventional needle catheter, and which indicates continuously during intravenous cannulation whether the tip of the needle is inside or outside of a vein, to assist a clinician in intravenous cannulation.
Also known as: SU-VEID
Percentage of Participants With IV Access at First Attempt
Percentage of participants to have an IV access within the first attempt when using the SU-VEID Device in comparison to the conventional procedure
Time frame: Baseline
| Milestone | Standard IV Insertion | SU-VEID Assisted IV Insertion |
|---|---|---|
| Started | 84 | 85 |
| Completed | 84 | 85 |
| Not completed | 0 | 0 |
Percentage of participants to have an IV access within the first attempt when using the SU-VEID Device in comparison to the conventional procedure
| percentage of participants | Standard IV Insertion | SU-VEID Assisted IV Insertion |
|---|---|---|
| Percentage of Participants With IV Access at First Attempt | 70.2 | 67.1 |
Collected over Adverse events were collected from baseline to end of study participation for a total of approximately 1 day on all participants.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Standard IV Insertion | 0/84 (0%) | 0/84 (0%) | 0/84 (0%) |
| SU-VEID Assisted IV Insertion | 0/85 (0%) | 0/85 (0%) | 0/85 (0%) |
| Age, Continuous(years) | Standard IV Insertion | SU-VEID Assisted IV Insertion | Total |
|---|---|---|---|
| Mean | 5.31 ± 3.99 | 5.35 ± 4.19 | 5.33 ± 4.086 |
| Sex: Female, Male(Participants) | Standard IV Insertion | SU-VEID Assisted IV Insertion | Total |
|---|---|---|---|
| Female | 36 | 36 | 72 |
| Male | 48 | 49 | 97 |
| Race and Ethnicity Not Collected(Participants) | Standard IV Insertion | SU-VEID Assisted IV Insertion | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Standard IV Insertion | SU-VEID Assisted IV Insertion | Total |
|---|---|---|---|
| United States | 84 | 85 | 169 |
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This study is terminated, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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