Shunt; Complications, Ventricular (Communicating)ShuCSNCT02778997
Prospective Shunt Complication Study
An observational study of Shunt; Complications, Ventricular (Communicating), run by University of Zurich at 2 sites in Switzerland.
Trial summary
Complications in patients with cerebrospinal fluid (CSF) shunts are common. Thus, these patients are frequently admitted for suspicion of a shunt dysfunction (SD). However, the symptoms of a SD are often unspecific and the required diagnostics are time consuming, expensive, invasive and may involve radiation exposure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shunt; Complications, Ventricular (Communicating)
- What is being tested?
- CSF Shunt treatment for hydrocephalus
- Type of treatment
- Surgery or procedure
- How many people
- 150 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 1 Apr 2017to 1 Jul 2027
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All adult patients with CSF shunt
Who may be able to join
- Age >= 18
- State after implantation of a CSF shunt
Who cannot join
- refusion participation in the study
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
Dept. of Neurosurgery, Zurich University Hospital
Zurich, 8091
Zurich University Hospital
Zurich
About this study
Official title: Prospective Shunt Complication Study (Pro-ShuCS)
Complications in patients with cerebrospinal fluid (CSF) shunts are common. Thus, these patients are frequently admitted for suspicion of a shunt dysfunction (SD). However, the symptoms of a SD are often unspecific and the required diagnostics are time consuming, expensive, invasive and may involve radiation exposure. In a prospective observational study it is planned to find out, how often a suspected shunt dysfunction is found, which kinds of shunt dysfunction are seen and if there is a correlation between the shunt dysfunctions and the age of the shunt. Furthermore, it is intended to find out, if there are symptom-patterns specific for certain shunt dysfunctions.
Read the detailed description
All patients who are admitted for suspected shunt-dysfunction will be included. Patient data, detailed data about the shunt, patient's symptoms and all findings will be recorded in the CRF. After 4-8 weeks all patients will be followed-up to add missing data and correct initial findings with the benefit of a retrospective view. After 2 years, data will be analyzed.
- Being tested
- CSF Shunt treatment for hydrocephalus
- Keywords
- Shunt, CSF, Dysfunction, Complication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CSF Shunt treatment for hydrocephalusProcedure or surgery
State after CSF shunt implantation
What is being measured
The primary outcome is the main question the study is designed to answer.
Confirmation of Shunt Dysfunction (yes/no)
The correctness of the suspected diagnosis of a shunt dysfunction
Measured: 4-8 weeks after first presentation
Kind of Shunt Dysfunction (infection/disruption/kinking/obstruction/others)
In case of a confirmed shunt dysfunction, the kind of dysfunction is recorded
Measured: 4-8 weeks after first presentation
Alternate Diagnosis (multiple diagnoses possible)
If the suspected diagnosis of a shunt dysfunction is not approved, the alternate diagnosis leading to the patient's symptoms is recorded. Every possible medical disorder might lead to presentation of the patient. Thus, no catalogue of possible diagnoses is given.
Measured: 4-8 weeks after first presentation
Time Span after Shunt Implantation (months)
Certain kinds of shunt dysfunctions seem to appear at a certain "age" of a shunt. The time after implantation/last revision of the shunt is recorded. The age of the shunt / time span after first implantation is measured in months.
Measured: 4-8 weeks after first presentation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2016 (estimated)
- Study start1 Apr 2017
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Jul 2027 (estimated)
Why it stopped: Responsible investigator left the team. Suspended until replacement is found.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shunt; Complications, Ventricular (Communicating)Studies of the same condition, open and under way.
- More trials run by University of ZurichThe 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 only
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luca Regli, MD, Study director, Zurich University Hospital, Dept. of NeurosurgeryLennart H Stieglitz, MD, Principal investigator, Zurich University Hospital, Dept. of Neurosurgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02778997
- Sponsor's protocol ID
- 2016-00174
- Other IDs
- 2016
- Acronym
- ShuCS
- Status last verified
- Apr 2025
- First submitted
- 25 Apr 2016
- Last updated
- 6 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Shunt Complication Study (Pro-ShuCS)
- ClinicalTrials.gov ID
- NCT02778997
- Acronym / sponsor ID
- ShuCS / 2016-00174
- Keywords
- Shunt, CSF, Dysfunction, Complication
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: Responsible investigator left the team. Suspended until replacement is found.
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 20 May 2016 (estimated)
- 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.
Complications in patients with cerebrospinal fluid (CSF) shunts are common. Thus, these patients are frequently admitted for suspicion of a shunt dysfunction (SD). However, the symptoms of a SD are often unspecific and the required diagnostics are time consuming, expensive, invasive and may involve radiation exposure. In a prospective observational study it is planned to find out, how often a suspected shunt dysfunction is found, which kinds of shunt dysfunction are seen and if there is a correlation between the shunt dysfunctions and the age of the shunt. Furthermore, it is intended to find out, if there are symptom-patterns specific for certain shunt dysfunctions.
Detailed description
All patients who are admitted for suspected shunt-dysfunction will be included. Patient data, detailed data about the shunt, patient's symptoms and all findings will be recorded in the CRF. After 4-8 weeks all patients will be followed-up to add missing data and correct initial findings with the benefit of a retrospective view. After 2 years, data will be analyzed.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult patients with CSF shunt
Key inclusion criteria (2 listed)
- Age >= 18
- State after implantation of a CSF shunt
Key exclusion criteria (1 listed)
- refusion participation in the study
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 |
|---|---|---|
| CSF Shunt treatment for hydrocephalusState after CSF shunt implantation | Procedure or surgery | – |
Primary outcome
Confirmation of Shunt Dysfunction (yes/no)
Time frame: 4-8 weeks after first presentation
The correctness of the suspected diagnosis of a shunt dysfunction
Kind of Shunt Dysfunction (infection/disruption/kinking/obstruction/others)
Time frame: 4-8 weeks after first presentation
In case of a confirmed shunt dysfunction, the kind of dysfunction is recorded
Alternate Diagnosis (multiple diagnoses possible)
Time frame: 4-8 weeks after first presentation
If the suspected diagnosis of a shunt dysfunction is not approved, the alternate diagnosis leading to the patient's symptoms is recorded. Every possible medical disorder might lead to presentation of the patient. Thus, no catalogue of possible diagnoses is given.
Time Span after Shunt Implantation (months)
Time frame: 4-8 weeks after first presentation
Certain kinds of shunt dysfunctions seem to appear at a certain "age" of a shunt. The time after implantation/last revision of the shunt is recorded. The age of the shunt / time span after first implantation is measured in months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2025.
- Individual participant dataSharing planned: No
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.
Luca Regli, MD study director
Zurich University Hospital, Dept. of Neurosurgery
Lennart H Stieglitz, MD principal investigator
Zurich University Hospital, Dept. of Neurosurgery
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Shunt; Complications, Ventricular (Communicating), run by University of Zurich at 2 sites in Switzerland.
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 2 inclusion and 1 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: paused, as of the sponsor's last update on 6 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. 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?
Results are not available in the source record.
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?
Confirmation of Shunt Dysfunction (yes/no) (time frame: 4-8 weeks after first presentation). The study lists 4 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 Apr 2025.