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Hydrocephalus clinical trials

View clinical trials related to Hydrocephalus.

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NCT ID: NCT06402786 Not yet recruiting - Hydrocephalus Clinical Trials

First-in-human Trial of Home Brain Pressure Measured Using Kitea ICP Sensor, Placed During Hydrocephalus Shunt Surgery.

HomeICP
Start date: May 2024
Phase: N/A
Study type: Interventional

Patients with hydrocephalus have an abnormal build-up of fluid around the brain and need a tube surgically implanted to drain that fluid. Patients and their caregivers live with the constant fear that the tube will block. Warning symptoms include irritability, headaches and vomiting. Unfortunately, there is no way of telling when fluid build-up is causing a rise in brain pressure and potentially impeding blood flow to the brain (life threatening) except for a brain scan in hospital and possibly hospitalisation. The investigators want to improve the lives of patients with hydrocephalus. They have developed a tool for parents and caregivers to monitor the pressure in the brain remotely via a sensor placed alongside the drainage tube. The device has been shown to be safe and to give reliable brain pressure readings using a large animal model (sheep). This study is a first-in-human safety study to show it is safe for patient use.

NCT ID: NCT06383169 Completed - Clinical trials for Investigate the Effect of External Lumbar Cistern Drainage in Preventing Postoperative Hydrocephalus in Patients Who Have Undergone Meningioma Surgery

Impact of External Drainage of the Lumbar Cistern in Patients With Hydrocephalus Following Meningioma Surgery and Its Influence on Patient Satisfaction

Start date: May 1, 2019
Phase:
Study type: Observational

This study aims to investigate the effect of external lumbar cistern drainage in preventing postoperative hydrocephalus in patients who have undergone meningioma surgery and its impact on patient satisfaction.

NCT ID: NCT06368648 Not yet recruiting - Stroke Clinical Trials

CoMind Early Feasibility Study

CoMind EFS
Start date: June 2024
Phase:
Study type: Observational

The purpose of this research, which has been determined as non-significant risk by the central IRB overseeing the study, is to obtain information to help further develop a machine (a medical device) to measure the pressure around the brain from the outside (this pressure is called intracranial pressure or ICP). Monitoring and managing ICP is an important part of care for patients with conditions such as Traumatic Brain Injury (TBI). However, the current way of measuring ICP requires surgery to drill a hole into the skull, and therefore can introduce additional risks such as infections and pain. Recent research has shown it may be possible to measure ICP without needing surgery. This technology is in development, but large amounts of data is required to build these new devices. Through collecting a large database of information from patients who have both the routine surgical device and the research device applied to their head, the research team will work to develop and test an effective and potentially safer way of monitoring patient ICP.

NCT ID: NCT06341946 Not yet recruiting - Hydrocephalus Clinical Trials

Role of Endoscopic Third Ventriculostomy in Management of Malfunctioning Ventriculoperitoneal Shunt

Start date: April 5, 2024
Phase: N/A
Study type: Interventional

The aim of this study is to analyze our experience in management of malfunctioning ventriculoperitoneal shunt by using endoscopic third ventriculostomy (ETV).

NCT ID: NCT06313879 Recruiting - Clinical trials for Hydrocephalus in Children

The Effect of Education Given to Parents of Children With Ventriculoperitoneal Shunt on Their Anxiety and Self-efficacy

Start date: March 10, 2024
Phase: N/A
Study type: Interventional

This study aims to evaluate the effect of tele-education given to parents of children with ventriculoperitoneal shunt on their anxiety and self-efficacy.

NCT ID: NCT06310213 Not yet recruiting - Clinical trials for Hydrocephalus in Infants

Non-Invasive Pressure Monitor for Neonates & Infants at Risk of Developing Hydrocephalus

Start date: April 1, 2024
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to test a modified smart soft contact lens in neonates and infants at risk of developing hydrocephalus. The main questions it aims to answer are: - Can the device distinguish between intracranial pressure variations in neonates and infants diagnosed with hydrocephalus and those without - Can the device compare pressure dynamics between pre- and post-operative periods in neonates and infants who undergo surgical treatments Participants will undergo standard of care evaluations for hydrocephalus (anterior fontanelle assessment and head circumference measurement) and wear the device during standard of care evaluation; pre- and post- ventricular reservoir taps, as applicable; and/or pre- and post-operatively, as applicable.

NCT ID: NCT06276543 Not yet recruiting - Hydrocephalus Clinical Trials

Bactiseal Catheter Safety Registry Study

Start date: June 1, 2024
Phase:
Study type: Observational

Research Purpose: This study aims to continuously evaluate the safety of subjects implanted with a catheter (trade name: Bactiseal) produced by Integra LifeSciences Production Corporation. Device safety will be assessed based on all the adverse events that occurred within 2 years after implanted the catheter. Research Design: This study is designed to be single arm, multi-center, and retrospective. A total of 200 subjects will be retrospectively enrolled. Information will be collected on adverse events, including bacterial culture and drug resistance testing when infection (if done), of subjects enrolled within 2 years after the implantation of the Bactiseal Catheter between January 01, 2019 and June 30, 2022. The following information will be collected from subjects' medical records or hospitals' databases (if any): 1. General condition of the subjects (including previous shunting and external drainage operation) 2. Intraoperative condition and catheter implantation 3. Information on the shunt catheters 4. Adverse events of subjects within 2 years after the operation and classification of the adverse events (except anticipated adverse events listed in section 8.1.2) 5. Relevant examinations in case of postoperative infection, including bacterial culture and drug resistance testing (if done)

NCT ID: NCT06253858 Not yet recruiting - Hydrocephalus Clinical Trials

Ultrasound (US) Guided External Ventricular Catheter Placement

Start date: July 1, 2024
Phase: N/A
Study type: Interventional

To assess the accuracy the SOLOPASS® System US based in the placement of external ventricular drain into the cranial cavity. This study will aim at evaluating the proposed efficacy of the device in targeting the brain ventricles and decrease multiple brain passes, incorrect deployment and malfunctioning of the drain.

NCT ID: NCT06147414 Not yet recruiting - Cystic Fibrosis Clinical Trials

Development of Non-Invasive Prenatal Diagnosis for Single Gene Disorders

DANNIgene
Start date: April 2024
Phase:
Study type: Observational

Cell-free fetal DNA (cffDNA) is present in the maternal blood from the early first trimester of gestation and makes up 5%-20% of the total circulating cell-free DNA (cfDNA) in maternal plasma. Its presence in maternal plasma has allowed development of noninvasive prenatal diagnosis for single-gene disorders (SGD-NIPD). This can be performed from 9 weeks of amenorrhea and offers an early, safe and accurate definitive diagnosis without the miscarriage risk associated with invasive procedures. One of the major difficulties is distinguishing fetal genotype in the high background of maternal cfDNA, which leads to several technical and analytical challenges. Besides, unlike noninvasive prenatal testing for aneuploidy, NIPD for monogenic diseases represent a smaller market opportunity, and many cases must be provided on a bespoke, patient- or disease-specific basis. As a result, implementation of SGD-NIPD remained sparse, with most testing being delivered in a research setting. The present project aims to take advantage of the unique French collaborative network to make SGD-NIPD possible for theoretically any monogenic disorder and any family.

NCT ID: NCT06132139 Not yet recruiting - Clinical trials for Subarachnoid Hemorrhage

VisAR Augmented Reality Navigation of Ventriculostomy

Start date: March 2024
Phase: N/A
Study type: Interventional

This study is intended to evaluate the feasibility of using VisAR augmented reality surgical navigation during placement of an external ventricular drain (EVD). The investigators are interested in confirming the design of the VisAR headset is compatible with this bedside procedure.