CompletedNo phase
Intraoperative Ultrasound Guided Compared to Stereotactic Navigated Ventriculoperitoneal Shunt Placement
Key facts
- Who runs it
- University Hospital, Basel, Switzerland
- Where
- Switzerland1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Completed
- People taking part
- 136 people enrolled
- Started
- 26 Feb 2020
- Ended
- 6 Jan 2025
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- US -G VPS placement, done by BK Medical 5000 US with burr hole probe (type 9063 N11C5S, 11-5 MHz).
- Stereotactic navigation for VPS placement (Brainlab Dual Curve System with cranial navigation software version 3.1).
- Record updated
- 7 March 2025
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 8 criteriaShow less
Who can take part
- Informed Consent as documented by signature
- Patients undergoing elective or emergent VPS placement (frontal or occipital shunt )
Who cannot take part
- Revision surgery due to former VPS placement using the same side and location for VPS placement or when no complete shunt is revised (proximal and distal), resulting in a shorter operation time
- Previous enrolment into the current study
- Ventriculoatrial or ventriculopleural Placement
- Women who are pregnant or breast feeding
- Intention to become pregnant during the course of the study
- Enrolment of the investigator, his/her family members, employees, and other dependent persons
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
This study is to prospectively compare Ultrasound guided (US-G) Ventriculoperitoneal Shunt (VPS) placement to stereotactic navigation in a randomized controlled fashion with the surgical intervention time as primary outcome. All patients entering the University Hospital of Basel for elective or emergent VPS surgery will be randomized in 1:1 fashion to one of the study groups at admission or the day before the operation.
The 2 groups in the trial
- US -G VPS placementExisting treatment, for comparison
Treatment: US -G VPS placement, done by BK Medical 5000 US with burr hole probe (type 9063 N11C5S, 11-5 MHz).
- Stereotactic navigation for VPS placementExisting treatment, for comparison
Treatment: Stereotactic navigation for VPS placement (Brainlab Dual Curve System with cranial navigation software version 3.1).
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Intraoperative Ultrasound Guided Compared to Stereotactic Navigated Ventriculoperitoneal Shunt Placement: A Randomized Controlled Study
- Record updated
- 7 March 2025