- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04190641
Single-use Cystoscope System for Direct Visualization of the Urethra and Bladder
Clinical Investigation to Evaluate the Direct Visualization Performances of Ambu® aScope™ 4 Cysto and aView™ Urologia for Examination of the Lower Urinary Tract
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Clinical Phase: pre-CE study
Design: A non-randomized confirmatory study on the visualization performance of the Ambu® aScope™ 4 Cysto and aView™ Urologia in 42 fully evaluable, adults subjects aimed at identification of known pathological findings (papillary bladder or small resectable lesion) detected with Ambu® aScope™ 4 Cysto and aView™ Urologia and subsequently during a repeat procedure using a reusable rigid scope or resectoscope at the time of planned transurethral resection of bladder tumours (TURBT).
Population: Adult subjects (≥ 18 years) in the OR undergoing planned transurethral resection of bladder tumors TURBT
Planned sample size: A total of 42 patients will result in a maximum (if the true proportion is 50 %) width of the two-sided 95 % confidence interval for the binary variable "Confirmed" to be 15%. This width is considered to be useful in the interpretations of the results from this investigation.
Study duration: Screening, procedure and follow-up will take 15 days maximum
Follow-up duration: Follow-up immediately after procedure
Investigational Device: Ambu® aScope™ 4 Cysto and aView™ Urologia Pre-CE, single use cystoscope.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Herlev, Denmark, DK-2730
- Herlev Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Willing to sign the informed consent
- Adults (males and females), ≥18 years of age or older
- Able to undergo routine cystoscopy
- Patients diagnosed with papillary bladder or small resectable lesion where transurethral resection of the tumour/lesion is planned
Exclusion Criteria:
- 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
- Pregnant or lactating women
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Flexible cystoscopy
Visualization of the urethra and bladder with the Ambu® aScope™ 4 Cysto and aView™ Urologia
|
Visualization of the urethra and the bladder
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
performance of Ambu® aScope™ 4 Cysto and aView™ Urologia
Time Frame: follow up immediately after procedure
|
The performance level of Ambu® aScope™ 4 Cysto and aView™ Urologia, compared to current standard practice with re-usable cystoscopes, is defined as proportion of patients with one or more papillary bladder lesion or small resectable lesion (diagnosed a maximum of one month prior to resection) detected with the Ambu® aScope™ 4 Cysto and aView™ Urologia (prior to planned transurethral resection of bladder tumors (TURBT)) and confirmed with the rigid cystoscope during TURBT.
|
follow up immediately after procedure
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety of Ambu® aScope™ 4 Cysto and aView™ Urologia
Time Frame: follow up immediately after procedure
|
Evaluate the safety of Ambu® aScope™ 4 Cysto and aView™ Urologia for direct visualization of the urethra and bladder by assessing the adverse events during and immediately after the flexible cystoscopy with Ambu® aScope™ 4 Cysto and aView™ Urologia, prior to start of TURBT
|
follow up immediately after procedure
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Investigator performance
Time Frame: follow up immediately after procedure
|
Measure of the overall performance 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.
|
follow up immediately after procedure
|
Procedure time
Time Frame: follow up immediately after procedure
|
Measure of the overall procedure time
|
follow up immediately after procedure
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CIS-013
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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