NCT03105557

Specturi Device - Feasibility Study

Specturi Device Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 20 (actual)
• Sponsor: Capturin Distribution B.V. · Industry
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

Summary

On a daily basis many (prematurely born) newborn are subjected to different urine collecting techniques to study biochemical abnormalities. Neonatology nurses and pediatricians are looking for a better and less invasive manner to collect urine in these vulnerable patients. We hypothesise that the urine collecting device as presented in this protocol is less invasive and has good functional abilities to collect urine in these newborns Objective of the study: Clinical feasibility of the urine collection device, indicated by staff and parents. Study design: The study will be an open label, clinical feasibility study, of the urine collection device. During a period of 6 months, 30 feasibility tests will be performed. Study population: Prematurely born newborns, admitted to the neonatology unit of the department of pediatrics at Rijnstate Hospital Arnhem.

Conditions

• Rickets

Interventions

Type	Name	Description
DEVICE	Urinary collecting device	Urinary collecting device

Timeline

• Start date: 2020-01-27
• Primary completion: 2025-02-05
• Completion: 2025-02-05
• First posted: 2017-04-10
• Last updated: 2026-02-27

Locations

1 site across 1 country: Netherlands