Ignite Creation Date:
2024-05-05 @ 5:21 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00437528
Status:
UNKNOWN
Last Update Posted:
2007-05-17
First Post:
2007-02-19
Brief Title:
Safety and Applicability Study of a Novel Heat Flow Sensor Unit for Measuring Urinary Bladder Capacity
Sponsor:
Rambam Health Care Campus
Organization:
Rambam Health Care Campus
Study Overview
Official Title:
Phase I Study for Evaluating the Safety and Applicability of a Novel Heat Flow Sensor Unit for Measuring Urinary Bladder Capacity
Status:
UNKNOWN
Status Verified Date:
2007-02
Last Known Status:
RECRUITING
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:
None
Brief Summary:
A novel sensor a device named sensurinewas developed in the aim of real- time measurement of bladder volume The sensurine device is a wearable fully passive non-invasive and compact heat flow sensor patent pending and electronic control unit The device will serve as a tool for managing and treating bladder dysfunction by behavioral treatment such as overactive bladder without incontinence urge incontinence and voiding difficulties In this phase I of the clinical trial the sensor unit will be tested for technological feasibility demonstration and for collecting design data
Detailed Description:
The Primary objectives are to asses the safety and the physical performance of the SenseUrines sensor unit and to validate the concept of determining bladder volume by measuring heat flow The Secondary objective is to optimize the device accuracy Primary endpoints To show that the sensor has no negative effect on the subject to determine bladder urine volume based on the sensors signals in an accuracy of 10 compared to the actual volume Secondary endpoint - to determine bladder urine volume in an accuracy of 10 in different ambient conditions temperature and clothing
Inclusion criteria - All subjects will be aged 18-50 active in good general health and without urinary complaints or documented urinary tract dysfunctions Exclusion criteria - Pregnancy breast feeding known allergic sensitivity to medical adhesive tapes cognitive incompatibility and mental incompetence
On the first visit the subject will sign an informed consent form A medical intake including demographic data will be collected Stage 1 will serve for basic testing of the sensor unit and for measuring the maximal and minimal bladder volume The sensor will be attached to the lower abdomen wall and checked for functionality Each subject will fill up his bladder by drinking water until sensing a strong urge to void The subject will then void until he is empty into a measurement cup Ultrasound measurement US of bladder volume and sensor signal will be read and recorded by a standard miliVoltmeter just before and immediately after emptying the bladder Sensor US and cup measurement readings will not be done by the same investigator Continuing to stage 2 will depend on the preliminary results sensor readings compared to the measured volume and US readings determining feasibility Stage 2 will serve for measuring the dynamics of bladder heat conductivity during the filling and voiding phases On the 2nd visit the subject will fill up his bladder by gradually drinking 500CC of water over 60-90 minutes until sensing a strong urge to void The subject will drink an additional 50-100CC of water and wait around 10 minutes in the aim of achieving maximal bladder capacity The sensor signals will be recorded from the beginning of this bladder filling stage every 5-10 minutes Then the subject will be requested to void in a controlled manner and to intentionally stop urinating after emptying 50-100CC of urine voided volume will be determined by the measurement cup The controlled voiding of 50-100CC will be repeated until the bladder is empty The sensor signals will be read and recorded during both stages Visit 3 will be performed in the same manner but in different positions during measurements supine-on the back sides and front sitting and standing Visit 4 final visit will serve for demonstrating the sensor units performance in different ambient temperature and clothing Two subjects will be randomly selected to examine the sensor in an ambient of 15ºC this will be controlled by an air-conditioned room with an external thermometer for measuring the dynamic range maximal and minimal bladder capacity The same will be done at room temperature twice- with light and heavy clothing The other 2 subjects will be randomly selected to examine the sensors performance in an ambient of 40ºC hot temperature will be achieved by an electric heater in a small room controlled with an external thermometer for measuring the dynamic range maximal and minimal bladder capacity The same will be done at room temperature twice- with light and heavy clothing
All output signals will be logged and processed to show the correlation between the calculated heat conductance of the bladder and the volume A table consisting the calculated indexes of conductivity vs bladder volumes will be designed
General 10 subjects will be recruited by advertisement with notification of some compensation for their time and travel to the study site Every session will last about 4 hours long In each working day 3-5 subjects will participate and the total trial period is expected to be approximately 20 working days
Inclusion criteria - All subjects will be aged 18-50 active in good general health and without urinary complaints or documented urinary tract dysfunctions Exclusion criteria - Pregnancy breast feeding known allergic sensitivity to medical adhesive tapes cognitive incompatibility and mental incompetence
On the first visit the subject will sign an informed consent form A medical intake including demographic data will be collected Stage 1 will serve for basic testing of the sensor unit and for measuring the maximal and minimal bladder volume The sensor will be attached to the lower abdomen wall and checked for functionality Each subject will fill up his bladder by drinking water until sensing a strong urge to void The subject will then void until he is empty into a measurement cup Ultrasound measurement US of bladder volume and sensor signal will be read and recorded by a standard miliVoltmeter just before and immediately after emptying the bladder Sensor US and cup measurement readings will not be done by the same investigator Continuing to stage 2 will depend on the preliminary results sensor readings compared to the measured volume and US readings determining feasibility Stage 2 will serve for measuring the dynamics of bladder heat conductivity during the filling and voiding phases On the 2nd visit the subject will fill up his bladder by gradually drinking 500CC of water over 60-90 minutes until sensing a strong urge to void The subject will drink an additional 50-100CC of water and wait around 10 minutes in the aim of achieving maximal bladder capacity The sensor signals will be recorded from the beginning of this bladder filling stage every 5-10 minutes Then the subject will be requested to void in a controlled manner and to intentionally stop urinating after emptying 50-100CC of urine voided volume will be determined by the measurement cup The controlled voiding of 50-100CC will be repeated until the bladder is empty The sensor signals will be read and recorded during both stages Visit 3 will be performed in the same manner but in different positions during measurements supine-on the back sides and front sitting and standing Visit 4 final visit will serve for demonstrating the sensor units performance in different ambient temperature and clothing Two subjects will be randomly selected to examine the sensor in an ambient of 15ºC this will be controlled by an air-conditioned room with an external thermometer for measuring the dynamic range maximal and minimal bladder capacity The same will be done at room temperature twice- with light and heavy clothing The other 2 subjects will be randomly selected to examine the sensors performance in an ambient of 40ºC hot temperature will be achieved by an electric heater in a small room controlled with an external thermometer for measuring the dynamic range maximal and minimal bladder capacity The same will be done at room temperature twice- with light and heavy clothing
All output signals will be logged and processed to show the correlation between the calculated heat conductance of the bladder and the volume A table consisting the calculated indexes of conductivity vs bladder volumes will be designed
General 10 subjects will be recruited by advertisement with notification of some compensation for their time and travel to the study site Every session will last about 4 hours long In each working day 3-5 subjects will participate and the total trial period is expected to be approximately 20 working days
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None