Evaluate the performance of Ambu® aScope* 4 Cysto and aView* Urologia for direct visualization and treatment of the urethra and bladder.Evaluate the patient tolerance to the procedure and the procedural time of Ambu® aScope* 4 Cysto and aView*…
ID
Source
Brief title
Condition
- Urinary tract signs and symptoms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The aim of this study is to evaluate the performance and safety of Ambu®
aScope* 4 Cysto and aView* Urologia for flexible cystoscopy.
Primary endpoint: - Rate of completion of procedure with Ambu® aScope* 4 Cysto
and aView* Urologia (Yes/No, Yes applies to 80% of procedures)
Secondary outcome
- Rate of overall performance during the procedure
- Rate of pain level experienced by the subject when inserting the flexible
cystoscope (measured on a visual analog scale
- Overall procedure time from insertion of flexible cystoscope to removal
The intended performances that will be investigated during this clinical
investigation are:
* Manoeuvrability
o Insertion of the endoscope in the lower urinary tract
o Navigation in the bladder
o Use of endoscopic accessories in the working channel
* Use of the working channel (eg. Irrigation and tools)
* Visual examination of the urothelium
* Visual confirmation of anatomical structures
* Visual confirmation of abnormalities in urethra and bladder
Background summary
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. The study will be
executed in adult subjects (* 18 years) undergoing flexible cystoscopy for
diagnostic or therapeutic purposes. The subjects should be above 18 years of
age or older, presenting for cystoscopy and ambulatory with a need to undergo
cystoscopy for diagnostic or therapeutic purposes.
The study is executed for post-CE mark purposes. The monitor used is also
investigated to understand to assess the visualisation performance. The monitor
is CE approved.
Study objective
Evaluate the performance of Ambu® aScope* 4 Cysto and aView* Urologia for
direct visualization and treatment of the urethra and bladder.
Evaluate the patient tolerance to the procedure and the procedural time of
Ambu® aScope* 4 Cysto and aView* Urologia for direct visualization and
treatment of the urethra and bladder
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
Intervention
The subjects will undergo a cystoscopy procedure.
Study burden and risks
There are no direct risks foreseen for participation in the study, as the
cystoscope is only used for viewing and the duration of the flexible cystoscopy
will normally take 10-15 minutes. The subject will be given local anaesthetics
which is standard clinical practice for this procedure. The subject might
experience some pain when inserting the cystoscope. For the next 24 hours the
subject may have a mild burning feeling when urinating and increased voiding
frequency. Mild bleeding can be present in the urine if biopsy or botox
injections are performed and the subjects takes blood thinning medication. This
are all symptoms which can be seen after cystoscopy using standard cystoscopes.
Baltorpbakken 13
Ballerup 2750
DK
Baltorpbakken 13
Ballerup 2750
DK
Listed location countries
Age
Inclusion criteria
i. Adults (males and females), *18 years of age or older, presenting for
cystoscopy
ii. Ambulatory with a need to undergo cystoscopy for diagnostic or therapeutic
purposes
iii. Willing to participate in a clinical trial
Exclusion criteria
i. History of high-grade bladder cancer or carcinoma-in-situ of the bladder,
undergoing cystoscopy for follow-up/surveillance purposes
ii. History of prior bladder/urethral reconstructive surgery
iii. Presence of symptomatic urinary tract infection (UTI)
iv. Known unpassable urethral stricture
v. Unable to read and/or understand the study requirements
vi. Unable or unwilling to provide consent to participation in the study
vii. Pregnant or lactating women
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL72049.078.19 |