Clinical Trials Logo

Clinical Trial Summary

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 Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04192474
Study type Interventional
Source Ambu A/S
Contact
Status Completed
Phase N/A
Start date July 21, 2020
Completion date June 30, 2021

See also
  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