Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06445426
Status:
COMPLETED
Last Update Posted:
2024-06-14
First Post:
2022-08-05
Brief Title:
Cystometry Using a Novel Microsensor System in Patients With Neurogenic Bladder Dysfunction
Sponsor:
Sunnaas Rehabilitation Hospital
Organization:
Sunnaas Rehabilitation Hospital
Study Overview
Official Title:
Cystometry Using a Novel Microsensor System in Patients With Neurogenic Bladder Dysfunction
Status:
COMPLETED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PEPRE2
Brief Summary:
The aim of this study is to assess the feasibility and safety of a novel system for percutaneous measurement of bladder pressure This system enables minimally invasive procedures and high-quality recordings offering a sampling rate and synchronization surpassing traditional methods The pressure sensor system has the potential to be developed into a low-cost method suitable for mass production The study will include a sample of convenience of up to 40 subjects Pressure will be recorded simultaneously in the bladder using both the conventional and novel pressure recording systems This simultaneous recording method will provide a direct comparison of pressure recordings between the two systems Subjects will be examined for any subjective or objective adverse events
Detailed Description:
The aim of this study is to assess the feasibility and safety of a novel system for measurement of bladder pressure The system facilitates a minimally invasive procedure enabling high-quality recordings with a sampling rate and synchronization that surpass conventional standards The pressure sensor system has potential to be developed into a low-cost method with mass production In patients with spinal cord injury and neurogenic bladder dysfunction measurement of pressure in the bladder cystometry is mandatory to evaluate risk factors and assess treatment options This novel system consists of a micro electro mechanical system MEMS integrated in a hollow flexible tube made out of biocompatible material Recording from this sensor catheter is transmitted to specialized electronic and digital devices for processing Due to a sensor catheter with a diameter less than 10 mm it is possible to perform transurethral cystometry using a simple minimally invasive technique The study goal is to compare the simultaneous measurement of the conventional water perfused system compared to a novel pressure sensor system during cystometry produce high-quality recordings with a higher than conventional sampling rate The study will include a sample of convenience of up to 40 subjects The pressure will be recorded simultaneously with the conventional and novel pressure recording system in the urinary bladder The simultaneous recording with the novel and the conventional method will provide a direct comparison of simultaneous recording of pressure between the two systems Patients will be examined for subjective or objective adverse events The sample size is too small for comparison of validity of the two methods in clinical practice However the study should be able to conclude on reliability Thus pressure measurements will be assessed with both methods during cystometry in up to 40 subjects Given the technical specifications the measurements are expected to be nearly identical thereby ensuring reliability The study is not intended to provide conclusive results on the comparison between conventional water perfused recording and the novel MEMS pressure system However results from this initial study will be the basis for further studies with sufficient power to validate conventional versus novel MEMS technique
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None