AzTrials
AzTrials

Ventriculoperitoneal Shunt (VPS)NaVPSNCT04450797

Intraoperative Ultrasound Guided Compared to Stereotactic Navigated Ventriculoperitoneal Shunt Placement

A study testing US -G VPS placement, done by BK Medical 5000 US with burr hole probe (type 9063 N11C5S, 11-5 MHz). and Stereotactic navigation for VPS placement (Brainlab Dual Curve System with cranial navigation software version 3.1). in people with Ventriculoperitoneal Shunt (VPS) and Hydrocephalus, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
US -G VPS placement, done by BK Medical 5000 US with burr hole probe (type 9063 N11C5S, 11-5 MHz). and Stereotactic navigation for VPS placement (Brainlab Dual Curve System with cranial navigation software version 3.1).
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
136 participants
Where
1 siteSwitzerland
Study dates
26 Feb 2020to 6 Jan 2025
Phase
Interventional
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

Who may be able to join

  • Informed Consent as documented by signature
  • Patients undergoing elective or emergent VPS placement (frontal or occipital shunt )

Who cannot join

  • 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
  • Ventriculoatrial or ventriculopleural Placement
  • Women who are pregnant or breast feeding
  • Intention to become pregnant during the course of the study
  • Previous enrolment into the current study
  • Enrolment of the investigator, his/her family members, employees, and other dependent persons

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • Department of Neurosurgery, University Hospital of Basel

    Basel, 4031

Other trials in Switzerland

About this study

Official title: Intraoperative Ultrasound Guided Compared to Stereotactic Navigated Ventriculoperitoneal Shunt Placement: A Randomized Controlled Study

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.

Read the detailed description

Ventriculoperitoneal shunt (VPS) placement is one of the most frequent procedures in neurosurgical practice. The position of the proximal ventricular catheter is important since it influences possible malfunction of the VPS. For the improvement of accuracy in proximal VPS placement, navigation-based insertion techniques have been developed. VPS placement using stereotactic navigation has shown a high accuracy of catheter placement been developed. VPS placement using stereotactic navigation has shown a high accuracy of catheter placement, while the main limitations are that for referencing, the head of the patient needs to be fixed in a head holder and the preoperative set-up can be time-consuming. US-G VPS placement using a burr hole probe was described as an alternate for image-guided VPS placement technique. For US-G VPS placement head fixation or preoperative registration is not needed. 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.

Being 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).
Keywords
Ventriculoperitoneal shunt (VPS)-dependency, VPS placement, Stereotactic Navigated Ventriculoperitoneal Shunt Placement, Ultrasound Guided (US-G) Ventriculoperitoneal Shunt Placement
Medical subject headings
Hydrocephalus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • US -G VPS placement, done by BK Medical 5000 US with burr hole probe (type 9063 N11C5S, 11-5 MHz).Device

    US -G VPS placement, done by BK Medical 5000 US with burr hole probe (type 9063 N11C5S, 11-5 MHz).

    Head not fixed, placed on horseshoe head holder, no preoperative navigation planning, catheter will be cut in length after positioning under real-time US guidance.

  • Stereotactic navigation for VPS placement (Brainlab Dual Curve System with cranial navigation software version 3.1).Device

    Stereotactic navigation for VPS placement (Brainlab Dual Curve System with cranial navigation software version 3.1).

    Head fixed in head clamp, entry point, trajectory and catheter length planned based on preoperative computer tomography imaging, catheter placed using navigated stylet.

Study groups in NCT04450797
Study groupRoleWhat they receive
US -G VPS placementActive comparatorNot described
Receives: Device: US -G VPS placement, done by BK Medical 5000 US with burr hole probe (type 9063 N11C5S, 11-5 MHz).
Stereotactic navigation for VPS placementActive comparatorNot described
Receives: Device: Stereotactic navigation for VPS placement (Brainlab Dual Curve System with cranial navigation software version 3.1).

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. surgical intervention time (minutes)

    time spent in the Operating Room (OR) by the surgeon, includes preparation time together (patient positioning, head clamping in the stereotactic navigation group) with the operation time of the neurosurgical part. Beginning ("positioning") and ending ("suture neurosurgical part") of this time interval is clearly defined and will be in a standardized manner recorded by blinded anaesthesiologists. . In the stereotactic navigation group, an additional 5 minutes will be added to the surgical intervention time for the preplanning of the navigation the day before the operation on the Brainlab workstation.

    Measured: at Operation day (V2, up to 24 hours)

Secondary outcomes (9)

  1. Operation time (minutes)

    Operation time (minutes): time in minutes from "cut" to "suture"

    Measured: at Operation day (V2, up to 24 hours)

  2. Anaesthesia time (minutes)

    Anaesthesia time (minutes): time in minutes from "start anaesthesia" to "end anaesthesia"

    Measured: at Operation day (V2, up to 24 hours)

  3. Number of puncture attempts

    Number of puncture attempts

    Measured: at Operation day (V2, up to 24 hours)

  4. Catheter placement (optimal vs. not optimal)

    Optimal catheter Placement: free-floating within the Cerebrospinal fluid (CSF) without touching ventricle wall or septum pellucidum, and the tip of the catheter located at the foramen of Monro showing an optimal length of the catheter. Catheters that did not fulfill all criteria have been defined as not optimal placed. Positioning of catheters will be further graded according to Yim et al. into grades I to IV (grade I: catheter terminates in the ipsilateral frontal horn, grade II: catheter terminates in contralateral frontal horn, grade III: catheter terminates in non-targeted CSF spaces, grade IV: catheter terminates intraparenchymally)

    Measured: at Operation day (V2,up to 24 hours), 2-3 days post-op. (V3), at discharge (V 4, approx. 7 days postop.), 6-8 weeks post-op (V5),6 months postop. (V6)

  5. Change in volumetry of side ventricles

    Change in volumetry of side ventricles pre- and postoperatively in cm3 (number and relative change)

    Measured: 1 day before Operation day (V1, up to 24 hours) and 2-3 days post-op. (V3)

  6. Change in Evan's Index

    Change in Evan's Index pre- and postoperatively (number and relative change).The Evans' index is the ratio of maximum width of the frontal horns of the lateral ventricles and the maximal internal diameter of the skull at the same level employed in axial CT images.

    Measured: before Operation day (V1) and 2-3 days post-op. (V3)

  7. rate of complications (infection, bleeding, complications associated with navigation method)

    rate of complications (infection, bleeding, complications associated with navigation method)

    Measured: from Operation day (V2, up to 24 hours) until 6 months postop. (V6)

  8. mortality

    mortality

    Measured: from Operation day (V2, up to 24 hours) until 6 months postop. (V6)

  9. revision surgery (yes/no)

    revision surgery (yes/no)

    Measured: from Operation day (V2,up to 24 hours) until 6 months postop. (V6)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jun 2020
  2. Study start26 Feb 2020
  3. Primary completion19 Jun 2024
  4. Study completion6 Jan 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
136 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04450797
Sponsor's protocol ID
2019-02157; ch20Leu
Other IDs
2019
Acronym
NaVPS
Status last verified
Mar 2025
First submitted
22 Jun 2020
Last updated
7 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Leu S, Hallenberger T, Rychen J, Pacan L, Christodoulou E, Blackham K, Greuter L, Halbeisen FS, Taub E, Westermann B, Guzman R, Mariani L, Soleman J. Ultrasound-guided versus stereotactically navigated ventriculoperitoneal shunt placement: a randomized clinical trial. Fluids Barriers CNS. 2026 Jun 26;23(1):85. doi: 10.1186/s12987-026-00833-2.

    PubMed 42363276

  • Leu S, Halbeisen F, Mariani L, Soleman J. Intraoperative ultrasound-guided compared to stereotactic navigated ventriculoperitoneal shunt placement: study protocol for a randomised controlled study. Trials. 2021 May 19;22(1):350. doi: 10.1186/s13063-021-05306-5.

    PubMed 34011396

Questions about this trial

What is this clinical trial studying?

A study testing US -G VPS placement, done by BK Medical 5000 US with burr hole probe (type 9063 N11C5S, 11-5 MHz). and Stereotactic navigation for VPS placement (Brainlab Dual Curve System with cranial navigation software version 3.1). in people with Ventriculoperitoneal Shunt (VPS) and Hydrocephalus, run by University Hospital, Basel, Switzerland at 1 site 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 6 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 7 Mar 2025. 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 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?

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?

surgical intervention time (minutes) (time frame: at Operation day (V2, up to 24 hours)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04450797, which also lists 2 linked publications.

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 7 Mar 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in