Lower Urinary Tract Symptoms Clinical Trial
Official title:
Clinical Investigation to Evaluate the Performance and Safety of Ambu® aScope™ 4 Cysto and aView™ Urologia for Flexible Cystoscopy
In this study, the new aScope 4 Cysto is used to see if this new single use, flexible cystoscope performs as well as other routinely used flexible cystoscopes. This study will be done in patients who come to the clinic for either a diagnosis of their urethra and bladder or for a small intervention. For an intervention a lesion or tumor is resected, a stent in the ureter is taken out, or an injection in the bladder wall is given. The flexible cystoscope is passed into the urethra and bladder for visual inspection of the bladder and urethra. It will give information on how well the structures of the urinary tract and bladder can be viewed including any abnormalities that are present. If an intervention is performed the aScope 4 Cysto will be used with an endoscopic accessory.
Clinical Phase: pre-CE study Design: A prospective, multicenter, single- arm open-label clinical study on the performance and safety of Ambu® aScope™ 4 Cysto and aView™ Urologia, a single-use, flexible cystoscope for flexible cystoscopy Population: Adult subjects (≥ 18 years) undergoing flexible cystoscopy for diagnostic or therapeutic purposes. Planned Sample Size: A total of 80 patients will result in a maximum (if the true proportion is 50 %) width (i.e. the difference between the point estimate and the upper, or lower, limit of the confidence interval) of the two-sided 95 % confidence interval for the binary variable "Performance level acceptable" to be 11%. This width is considered to be useful in the interpretations of the results from this part of the trial. Study duration: Screening, procedure and follow-up will take 14 days maximum. A follow-up telephone call at 7 days post procedure is performed to record any adverse events post-procedure. Planned Trial Period: 3 months Investigational Device: Ambu® aScope™ 4 Cysto and aView™ Urologia. A pre-CE, single use cystoscope. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04856748 -
Nomogram to Diagnose Prostatic Inflammation (PIN) in Men With Lower Urinary Tract Symptoms
|
||
Completed |
NCT03623880 -
Enhancing Behavioral Treatment for Women With Pelvic Floor Disorders
|
N/A | |
Enrolling by invitation |
NCT06317116 -
Examining the Relationship Between Core Muscles and Bladder Issues in Children
|
||
Completed |
NCT03625843 -
Mindfulness Exercises to Reduce Anxiety and Pain During Urodynamic Testing
|
N/A | |
Recruiting |
NCT05814614 -
Bladder Complaints in Parkinson's Disease Effectiveness of Pelvic Floor Muscle Exercises and Electrical Stimulation
|
N/A | |
Recruiting |
NCT04288427 -
5-Alpha Reductase 2 as a Marker of Resistance to 5ARI Therapy
|
N/A | |
Not yet recruiting |
NCT06452927 -
EEP in Patients With Urodynamically Proven DU/DA
|
N/A | |
Completed |
NCT02330107 -
Auriculotherapy on Lower Urinary Tract Symptoms in Elderly Men
|
N/A | |
Completed |
NCT03339609 -
Uroflow Measurement With Electromyography (EMG) to Identify Lower Urinary Tract Symptoms (LUTS): Conducted on Healthy Children
|
N/A | |
Terminated |
NCT02003742 -
Efficacy and Safety of a Single TRUS-guided Intraprostatic Injection of NX-1207 in Patients With LUTS Due to BPH
|
Phase 3 | |
Terminated |
NCT01003249 -
Dysfunctional Voiding and Lower Urinary Tract Symptoms With Baclofen
|
Phase 4 | |
Completed |
NCT01078545 -
Lucrin® Depot Efficacy and Safety Monitoring Study in Patients With Advanced Prostate Cancer and Lower Urinary Tract Symptoms (LUTS)
|
N/A | |
Completed |
NCT02074644 -
Clinical Trial of Prostatic Arterial Embolization Versus a Sham Procedure to Treat Benign Prostatic Hyperplasia
|
N/A | |
Recruiting |
NCT03802851 -
HoLEP Prior to Radiation Therapy for Patients With LUTS/Retention and Concurrent Prostate Cancer
|
N/A | |
Active, not recruiting |
NCT05415748 -
Deprescribing Tamsulosin in Older Men
|
Phase 4 | |
Recruiting |
NCT05702294 -
Electronic Urinary Flowmeter to Improve Accuracy of Bladder Diaries .
|
N/A | |
Enrolling by invitation |
NCT05537272 -
The Efficacy of Tamsulosin and Tadalafil Compared to Placebo in the Treatment and Prevention of Urinary Disorders After Transperineal Prostate Biopsy
|
Phase 4 | |
Recruiting |
NCT05826691 -
Benign Prostate Surgery and QOL and Sexual Function
|
||
Completed |
NCT04104100 -
Prevalence and Risk Factor of NP in Women With LUTS
|
||
Completed |
NCT04190641 -
Single-use Cystoscope System for Direct Visualization of the Urethra and Bladder
|
N/A |