ClinicalTrials.gg
CompletedNCT03105557Updated Feb 27, 2026

Specturi Device - Feasibility Study

An observational study in Rickets, sponsored by Capturin Distribution B.V.. Completed at 1 site in Netherlands. Open to female participants. Per ClinicalTrials.gov, last updated 2026-02-27.

Sponsored by Capturin Distribution B.V. · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
20
Sex
Female
01

Study 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.

02

Conditions studied

  • Rickets

Browse trials for

Keywords

  • Prematurely born newborns
  • Urine
  • Collecting device
03

In context

Rickets

36 studies on the registry are indexed under Rickets; 2 are open to participants now.

This study's enrollment of 20 is below the median of 80 across 11 observational studies indexed under Rickets.

Browse Rickets studies →

Lead sponsor

This is the only study on the registry with Capturin Distribution B.V. as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Subjects will consist of prematurely born neonates who are admitted to the neonatology unit. And for which the attending physician has an indication to screen for rickets using calcium,phosphate and creatinine level measurement in urine.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Neonates admitted to the neonatology unit of the paediatrics department of Rijnstate Hospital Medical indication for urine testing for Calcium, Phosphate and Creatinine levels from parents

Exclusion criteria

Exclusion Criteria:

  • No
  • Defective skin in genital region
  • Three previous tests in the same subject
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
20 participants (actual)
Patient registry
No

Interventions

  • DeviceUrinary collecting device

    Urinary collecting device

    Also known as: Capturin

06

What researchers measure

Primary outcomes

  1. Questionnaire based clinical feasibility of the urine collection device, indicated by staff and parents

    With concern to feasibility we want to know whether this device is able: * easy to apply to the neonate * to only collect urine * to exclude stool admixture * easy to use by the nurses * comfortable for te neonates

    Time frame: 1 day

Secondary outcomes

  1. Skin reactions

    Number of times skin reactions occurs, reported by the responsible nurse

    Time frame: 1 week

  2. Skin irritability

    Number of times skin irritability occurs, reported by the responsible nurse

    Time frame: 1 week

07

Study locations

1 site
  • Petra Van Setten
    Arnhem, Gelderland 6800 TA, Netherlands
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2020 to primary completion in Feb 2025, 60 months.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 3, 2017
First posted
Apr 10, 2017
StartActual
Jan 27, 2020
Primary completionActual
Feb 5, 2025
CompletionActual
Feb 5, 2025
Last update
Feb 27, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03105557
Lead sponsor
Capturin Distribution B.V.
Collaborators
Fonds NutsOhra, FrieslandCampina, Rijnstate Hospital, Scint B.V., Hertog Hendrik BV, University of Twente, Radboud University Medical Center
Responsible party
Sponsor
First posted
Apr 10, 2017
Start date
Jan 27, 2020
Primary completion
Feb 5, 2025
Completion
Feb 5, 2025
Last update
Feb 27, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion