UnknownPhase 1/2

Improvement of Peritoneal Catheter Placement in VPS With a Splitable Trocar

China40 participantsStarted 2022-01-01

Plain-language summary

This study is a phase I/IIa, single-center, open-labeled, randomized, controlled clinical trial. The aim of this study is to evaluate the safety and efficacy of a modified ventriculoperitoneal catheter placement using a splitable trocar for ventriculoperitoneal shunt.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Patients aged 18 years or older with new-onset hydrocephalus, including obstructive hydrocephalus, traffic hydrocephalus and special types of hydrocephalus, normal pressure hydrocephalus (NPH), idiopathic intracranial hypertension (IIH), benign intracranial hypertension, pseudotumor cerebri, etc., regardless of gender.
✓. Initial diagnosis of hydrocephalus requiring ventriculoperitoneal shunt or shunt failure requiring secondary surgery to replace the shunt.
✓. Provided written informed consent.

Exclusion criteria

✕. Previous abdominal surgery (except ventriculoperitoneal shunt).
✕. Pregnancy
✕. Peritonitis
✕. Patients with cognitive impairment and inability to communicate.
✕. Expected survival less than 6 months

What they're measuring

Rate of shunt failure

Timeframe: 6 months

Duration of the abdominal catheterization

Timeframe: During the surgery

Trial details

NCT IDNCT05476874

SponsorSouthern Medical University, China

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-06-30

Contact for this trial

Zhen-Zhou Chen, Dr.

+86-2062782768 czz1020@163.com

View on ClinicalTrials.gov More Hydrocephalus trials