Cystoscope, Lower Urinary Tract Symptoms, Bladder Disease
Conditions
Brief 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.
Detailed 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.
Interventions
DEVICEFlexible cystoscopy
Treatment with the investigational device: Ambu® aScope™ 4 Cysto
Sponsors
QserveCRO
Ambu A/S
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
A prospective, multicenter, single- arm open-label clinical study on the performance and safety * 50% of the patients undergo flexible diagnostic cystoscopy * 50% of the patients undergo flexible cystoscopy intervention with endoscopic accessories
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults (males and females), ≥18 years of age or older, presenting for cystoscopy * Ambulatory with a need to undergo cystoscopy for diagnostic or therapeutic purposes * Willing to participate in a clinical trial
Exclusion criteria
* History of high-grade bladder cancer or carcinoma-in-situ of the bladder, undergoing cystoscopy for follow-up/surveillance purposes * History of prior bladder/urethral reconstructive surgery * Presence of symptomatic urinary tract infection (UTI) * Known unpassable urethral stricture * Unable to read and/or understand the study requirements * Unable or unwilling to provide consent to participation in the study * Pregnant or lactating women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Performance of the cystoscope | follow up immediately after procedure | Rate of completion of procedure with Ambu® aScope™ 4 Cysto and aView™ Urologia (yes/no, yes applies to 80% of the procedures) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall performance | follow up immediately after procedure | The overall performance will be further assessed by using a 5-point Likert scale with a minimum of one (=worst possible) to maximum of five (=best possible), to be completed by the investigator that performed the cystoscopy |
| Procedure time | follow up immediately after procedure | Procedure time in minutes |
| Patient Tolerance | follow up immediately after procedure | Patient tolerance to the procedure measured by 10-points visual analogue scale (VAS) after the flexible cystoscopy. VAS from 0= minimum discomfort and 10=maximum discomfort. |
| Adverse events | follow up immediately after procedure | Adverse events evaluation during and immediately after procedure |
Countries
Denmark, Netherlands
Outcome results
None listed