Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06394869
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-01
First Post:
2024-04-21
Brief Title:
Study to Assess the Impact of the Urine Test Cxbladder Detect on the Number of Cystoscopies Performed on Patients With Invisible Blood in Their Urine
Sponsor:
Pacific Edge Limited
Organization:
Pacific Edge Limited
Study Overview
Official Title:
Cystoscopic REDuction In BLadder Evaluations for Microhematuria - A Prospective Randomized Controlled Clinical Utility Study for Evaluation of Microhematuria The CREDIBLE Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
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:
CREDIBLE
Brief Summary:
This study includes adult patients who see a urologist because of blood in their urine The amount is so small it can only be seen with a microscope This is called microhematuria There can be many reasons for microhematuria One of them is bladder cancer While bladder cancer is one of the biggest worries it is only found in few of these patients
Most microhematuria patients will have a cystoscopy to look inside the bladder During a cystoscopy a small camera is inserted into the bladder This is done through the urethra the tube that passes urine from the bladder to the outside In some patients it can cause pain or anxiety Not all patients have a cystoscopy Those that dont usually return for a urine sample within 6 months This is done to check if there is still blood in their urine
This study is conducted to find out if the use of Cxbladder Detect changes the number of cystoscopies in microhematuria patients Cxbladder Detect is also called Detect It is a lab test that was developed to check how likely urothelial carcinoma is present in the bladder Urothelial carcinoma is by far the most common type of bladder cancer For the test the patient voids some urine into a cup A laboratory then checks the urine of specific genetic material Abnormalities can be a sign of urothelial carcinoma The result indicates if the urine is more like most normal urine or more like that of urothelial carcinoma patients
The study is done to find out how Detect changes the number of cystoscopies Study participants first void urine into a cup The urine is used for the Detect test The patients are then assigned to one of two groups The assignment is random This means the nobody can influence the assignment The chance to be assigned to either group is the same In the test group the urologist will receive the Detect result and discuss it with the patient Together they decide whether to do a cystoscopy In the control group the urologist will not receive the Detect result The patient will also not get the result The urologist and patient will follow standard of care to decide whether to do a cystoscopy
For test group patients the study gives a recommendation whether to proceed with cystoscopy It is based on the patients Detect result The urologist and patient do not need to follow the recommendation If the urologist does not follow it they will complete a survey the patient will be asked to complete a survey if they dont follow the urologists recommendation If the patient does not follow the urologists recommendation The survey has only one question It is asking for the reasons of the decision
After making their decision patients will follow the chosen pathway Data on the performed procedures are collected The diagnosis will also be documented Data will be collected for up to about 9 months
To see how Detect changes the number of cystoscopies these will be counted in each group and then compared
Most microhematuria patients will have a cystoscopy to look inside the bladder During a cystoscopy a small camera is inserted into the bladder This is done through the urethra the tube that passes urine from the bladder to the outside In some patients it can cause pain or anxiety Not all patients have a cystoscopy Those that dont usually return for a urine sample within 6 months This is done to check if there is still blood in their urine
This study is conducted to find out if the use of Cxbladder Detect changes the number of cystoscopies in microhematuria patients Cxbladder Detect is also called Detect It is a lab test that was developed to check how likely urothelial carcinoma is present in the bladder Urothelial carcinoma is by far the most common type of bladder cancer For the test the patient voids some urine into a cup A laboratory then checks the urine of specific genetic material Abnormalities can be a sign of urothelial carcinoma The result indicates if the urine is more like most normal urine or more like that of urothelial carcinoma patients
The study is done to find out how Detect changes the number of cystoscopies Study participants first void urine into a cup The urine is used for the Detect test The patients are then assigned to one of two groups The assignment is random This means the nobody can influence the assignment The chance to be assigned to either group is the same In the test group the urologist will receive the Detect result and discuss it with the patient Together they decide whether to do a cystoscopy In the control group the urologist will not receive the Detect result The patient will also not get the result The urologist and patient will follow standard of care to decide whether to do a cystoscopy
For test group patients the study gives a recommendation whether to proceed with cystoscopy It is based on the patients Detect result The urologist and patient do not need to follow the recommendation If the urologist does not follow it they will complete a survey the patient will be asked to complete a survey if they dont follow the urologists recommendation If the patient does not follow the urologists recommendation The survey has only one question It is asking for the reasons of the decision
After making their decision patients will follow the chosen pathway Data on the performed procedures are collected The diagnosis will also be documented Data will be collected for up to about 9 months
To see how Detect changes the number of cystoscopies these will be counted in each group and then compared
Detailed Description:
None
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