Prospective Shunt Complication Study (ShuCS)

April 2, 2025 updated by: University of Zurich

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.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Zurich, Switzerland, 8091
        • Dept. of Neurosurgery, Zurich University Hospital
      • Zurich, Switzerland
        • Zurich University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

All adult patients with CSF shunt

Description

Inclusion Criteria:

  • Age >= 18
  • State after implantation of a CSF shunt

Exclusion Criteria:

  • refusion participation in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Confirmation of Shunt Dysfunction (yes/no)
Time Frame: 4-8 weeks after first presentation
The correctness of the suspected diagnosis of a shunt dysfunction
4-8 weeks after first presentation
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
4-8 weeks after first presentation
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.
4-8 weeks after first presentation
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.
4-8 weeks after first presentation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Zurich

Investigators

  • Study Director: Luca Regli, MD, Zurich University Hospital, Dept. of Neurosurgery
  • Principal Investigator: Lennart H Stieglitz, MD, Zurich University Hospital, Dept. of Neurosurgery

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2017

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2027

Study Registration Dates

First Submitted

April 25, 2016

First Submitted That Met QC Criteria

May 17, 2016

First Posted (Estimated)

May 20, 2016

Study Record Updates

Last Update Posted (Actual)

April 6, 2025

Last Update Submitted That Met QC Criteria

April 2, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2016-00174

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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