RicketsNCT03105557
Specturi Device - Feasibility Study
An observational study of Rickets, run by Capturin Distribution B.V. at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Rickets
- What is being tested?
- Urinary collecting device
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteNetherlands
- Study dates
- 27 Jan 2020to 5 Feb 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Neonates admitted to the neonatology unit of the paediatrics department of Rijnstate Hospital Medical indication for urine testing for Calcium, Phosphate and Creatinine levels Informed consent from parents
Who cannot join
- No informed consent
- Defective skin in genital region
- Three previous tests in the same subject
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Specturi Device Study
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:
Read more
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
- Being tested
- Urinary collecting device
- Keywords
- Prematurely born newborns, Urine, Collecting device
- Medical subject headings
- Rickets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Urinary collecting deviceDevice
Also called Capturin
Urinary collecting device
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 day
Secondary outcomes (2)
Skin reactions
Number of times skin reactions occurs, reported by the responsible nurse
Measured: 1 week
Skin irritability
Number of times skin irritability occurs, reported by the responsible nurse
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2017
- Study start27 Jan 2020
- Primary completion5 Feb 2025
- Study completion5 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RicketsStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Capturin Distribution B.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Fonds NutsOhra, FrieslandCampina, Rijnstate Hospital, Scint B.V., Hertog Hendrik BV, University of Twente, Radboud University Medical Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03105557
- Sponsor's protocol ID
- NL55778.091.15
- Status last verified
- Feb 2026
- First submitted
- 3 Mar 2017
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Specturi Device Study
- ClinicalTrials.gov ID
- NCT03105557
- Acronym / sponsor ID
- NL55778.091.15
- Conditions
- Rickets
- Keywords
- Prematurely born newborns, Urine, Collecting device
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Capturin Distribution B.V.Industry (pharma, biotech, devices)
- Collaborators
- Fonds NutsOhra, FrieslandCampina, Rijnstate Hospital, Scint B.V., Hertog Hendrik BV, University of Twente, Radboud University Medical Center
- Study start
- 27 Jan 2020 (actual)
- Primary completion
- 5 Feb 2025 (actual)
- Study completion
- 5 Feb 2025 (actual)
- First posted
- 10 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Neonates admitted to the neonatology unit of the paediatrics department of Rijnstate Hospital Medical indication for urine testing for Calcium, Phosphate and Creatinine levels Informed consent from parents
Key exclusion criteria (3 listed)
- No informed consent
- Defective skin in genital region
- Three previous tests in the same subject
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Urinary collecting deviceAlso: CapturinUrinary collecting device | Device | – |
Primary outcome
Questionnaire based clinical feasibility of the urine collection device, indicated by staff and parents
Time frame: 1 day
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
2 secondary outcomes
Skin reactions
Time frame: 1 week
Skin irritability
Time frame: 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Rickets, run by Capturin Distribution B.V. at 1 site in Netherlands.
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: finished, as of the sponsor's last update on 27 Feb 2026. 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 Netherlands. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Questionnaire based clinical feasibility of the urine collection device, indicated by staff and parents (time frame: 1 day). 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 27 Feb 2026.