CystoscopeNCT04190641
Single-use Cystoscope System for Direct Visualization of the Urethra and Bladder
A study testing Ambu aScope 4 Cysto and aView Urologia in people with Cystoscope and Bladder Cancer, run by Ambu A/S at 1 site in Denmark.
Trial summary
In this study, the new aScope 4 Cysto is used to see how well it visualizes the lower urinary tract, and if this new flexible cystoscope performs as well as other routinely used cystoscopes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cystoscope, Bladder Cancer, Lower Urinary Tract Symptoms
- What is being tested?
- Ambu aScope 4 Cysto and aView Urologia
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteDenmark
- Study dates
- 8 Oct 2020to 6 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Investigation to Evaluate the Direct Visualization Performances of Ambu® aScope™ 4 Cysto and aView™ Urologia for Examination of the Lower Urinary Tract
In this study, the new aScope 4 Cysto is used to see how well it visualizes the lower urinary tract, and if this new flexible cystoscope performs as well as other routinely used cystoscopes. This study will be done in patients who have been diagnosed with bladder lesions and who will undergo surgery via the urethra to remove these lesions. The surgery is done under general anesthesia. After being brought under anesthesia and before removal of the lesion(s), the new flexible cystoscope is tested. The cystoscope will be used to visualize the urethra and bladder. Data will be collected on the number of the lesions that can be seen using the new cystoscope. During the planned surgery a resectoscope or rigid cystoscope will be used to confirm the number of lesions. The data will be used to show how well the cystoscope visualizes the lesions in comparison with routinely used cystoscopes. It will give information on how well the structures of the urinary tract and bladder can be viewed including any abnormalities that are present.Data will also be collected on the handling of the cystoscope: how well the cystoscope moves into the lower urinary tract, and how well it can be navigated through the lower urinary tract.
Read the 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.
- Conditions
- Cystoscope, Bladder Cancer, Lower Urinary Tract Symptoms
- Being tested
- Ambu aScope 4 Cysto and aView Urologia
- Medical subject headings
- Urinary Bladder Neoplasms, Lower Urinary Tract Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ambu aScope 4 Cysto and aView UrologiaDevice
Visualization of the urethra and the bladder
| Study group | Role | What they receive |
|---|---|---|
| Flexible cystoscopy | Other | Visualization of the urethra and bladder with the Ambu® aScope™ 4 Cysto and aView™ Urologia Receives: Device: Ambu aScope 4 Cysto and aView Urologia |
What is being measured
The primary outcome is the main question the study is designed to answer.
performance of Ambu® aScope™ 4 Cysto and aView™ Urologia
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.
Measured: follow up immediately after procedure
Secondary outcomes (3)
Safety of Ambu® aScope™ 4 Cysto and aView™ Urologia
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
Measured: follow up immediately after procedure
Investigator performance
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.
Measured: follow up immediately after procedure
Procedure time
Measure of the overall procedure time
Measured: follow up immediately after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2019
- Study start8 Oct 2020
- Primary completion30 Apr 2021
- Study completion6 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CystoscopeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A non-randomized confirmatory study
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ambu A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- QserveCRO
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04190641
- Sponsor's protocol ID
- CIS-013
- Status last verified
- Aug 2020
- First submitted
- 5 Dec 2019
- Last updated
- 14 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Investigation to Evaluate the Direct Visualization Performances of Ambu® aScope™ 4 Cysto and aView™ Urologia for Examination of the Lower Urinary Tract
- ClinicalTrials.gov ID
- NCT04190641
- Acronym / sponsor ID
- CIS-013
- Conditions
- Cystoscope, Bladder Cancer, Lower Urinary Tract Symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Ambu A/SIndustry (pharma, biotech, devices)
- Collaborators
- QserveCRO
- Study start
- 8 Oct 2020 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 6 Jul 2021 (actual)
- First posted
- 9 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study, the new aScope 4 Cysto is used to see how well it visualizes the lower urinary tract, and if this new flexible cystoscope performs as well as other routinely used cystoscopes. This study will be done in patients who have been diagnosed with bladder lesions and who will undergo surgery via the urethra to remove these lesions. The surgery is done under general anesthesia. After being brought under anesthesia and before removal of the lesion(s), the new flexible cystoscope is tested. The cystoscope will be used to visualize the urethra and bladder. Data will be collected on the number of the lesions that can be seen using the new cystoscope. During the planned surgery a resectoscope or rigid cystoscope will be used to confirm the number of lesions. The data will be used to show how well the cystoscope visualizes the lesions in comparison with routinely used cystoscopes. It will give information on how well the structures of the urinary tract and bladder can be viewed including any abnormalities that are present.Data will also be collected on the handling of the cystoscope: how well the cystoscope moves into the lower urinary tract, and how well it can be navigated through the lower urinary tract.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A non-randomized confirmatory study
| Arm | Type | Receives |
|---|---|---|
| Flexible cystoscopy | Other | Device: Ambu aScope 4 Cysto and aView UrologiaVisualization of the urethra and bladder with the Ambu® aScope™ 4 Cysto and aView™ Urologia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ambu aScope 4 Cysto and aView UrologiaVisualization of the urethra and the bladder | Device | Flexible cystoscopy |
Primary outcome
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.
3 secondary outcomes
Safety of Ambu® aScope™ 4 Cysto and aView™ Urologia
Time frame: follow up immediately after procedure
Investigator performance
Time frame: follow up immediately after procedure
Procedure time
Time frame: follow up immediately after procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2021.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ambu aScope 4 Cysto and aView Urologia in people with Cystoscope and Bladder Cancer, run by Ambu A/S at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
performance of Ambu® aScope™ 4 Cysto and aView™ Urologia (time frame: follow up immediately after procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2021.