HomeICPKitea Sensor for Home Monitoring of Brain Pressure in Hydrocephalus Patients
This study aims to evaluate the safety and tolerability of the Kitea ICP Sensor in patients with hydrocephalus, by monitoring the incidence of device-related serious adverse events within the 3 months following surgery.
Kitea ICP Sensor
Brain Diseases+1
+ Central Nervous System Diseases
+ Hydrocephalus
Treatment Study
Summary
Study start date: May 27, 2024
Actual date on which the first participant was enrolled.This study is focused on helping people with hydrocephalus, a condition where excess fluid accumulates in the brain, causing increased pressure. Many of these patients have shunts placed to help drain the fluid, but these shunts can sometimes fail, leading to repeated hospital visits. The goal is to see if monitoring brain pressure at home using a special device called the Kitea Sensor can reduce the need for hospitalizations. By allowing patients to keep track of their brain pressure, it might be possible to detect problems earlier and manage them more effectively. Participants in this study include both adults and children who need a shunt placed or revised. During their surgery, the Kitea Sensor is placed in the brain near the shunt. For three months after the surgery, participants will use the Kitea ICP System at home to check their brain pressure. This involves taking regular readings to monitor any changes in pressure. The study evaluates if this home monitoring can help manage hydrocephalus better and potentially reduce the number of hospital visits needed for shunt issues. Beyond the use of the Kitea Sensor, all other medical care will follow standard procedures.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.21 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 1 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location