Intraoperative Ultrasound Guided Compared to Stereotactic Navigated Ventriculoperitoneal Shunt Placement

  • STATUS
    Recruiting
  • days left to enroll
    44
  • participants needed
    130
  • sponsor
    University Hospital, Basel, Switzerland
Updated on 14 November 2021
probe
ventriculoperitoneal shunt

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. 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.

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.

Details
Condition Ventriculoperitoneal Shunt, ventriculo-peritoneal shunt, Hydrocephalus
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 placement (Brainlab Dual Curve System with cranial navigation software version 3.1).
Clinical Study IdentifierNCT04450797
SponsorUniversity Hospital, Basel, Switzerland
Last Modified on14 November 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note