CystoscopeNCT04192474
Evaluation of Performance and Safety of Ambu® aScope™ 4 Cysto and aView™ Urologia for Flexible Cystoscopy
A study testing Flexible cystoscopy in people with Cystoscope and Lower Urinary Tract Symptoms, run by Ambu A/S at 2 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cystoscope, Lower Urinary Tract Symptoms, Bladder Disease
- What is being tested?
- Flexible cystoscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 21 Jul 2020to 30 Jun 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
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Clinical Investigation to Evaluate the Performance and Safety of Ambu® aScope™ 4 Cysto and aView™ Urologia for Flexible Cystoscopy
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.
Read the 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.
- Conditions
- Cystoscope, Lower Urinary Tract Symptoms, Bladder Disease
- Being tested
- Flexible cystoscopy
- Medical subject headings
- Lower Urinary Tract Symptoms, Urinary Bladder Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flexible cystoscopyDevice
Treatment with the investigational device: Ambu® aScope™ 4 Cysto
| Study group | Role | What they receive |
|---|---|---|
| Flexible cystoscopy | Other | 50% of the patients undergo flexible diagnostic cystoscopy; 50% of the patients undergo flexible cystoscopy intervention with endoscopic accessories. Receives: Device: Flexible cystoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance of the cystoscope
Rate of completion of procedure with Ambu® aScope™ 4 Cysto and aView™ Urologia (yes/no, yes applies to 80% of the procedures)
Measured: follow up immediately after procedure
Secondary outcomes (5)
Overall performance
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
Measured: follow up immediately after procedure
Procedure time
Procedure time in minutes
Measured: follow up immediately after procedure
Patient Tolerance
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.
Measured: follow up immediately after procedure
Adverse events
Adverse events evaluation during and immediately after procedure
Measured: follow up immediately after procedure
Adverse events
Adverse events from discharge up to 7 days post-procedure (follow-up call)
Measured: follow-up at 7 days after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2019
- Study start21 Jul 2020
- Primary completion7 Apr 2021
- Study completion30 Jun 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- 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
- Masking
- None (open label)
- Enrolment
- 83 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
- NCT04192474
- Sponsor's protocol ID
- CIS-014
- Status last verified
- Sep 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 Performance and Safety of Ambu® aScope™ 4 Cysto and aView™ Urologia for Flexible Cystoscopy
- ClinicalTrials.gov ID
- NCT04192474
- Acronym / sponsor ID
- CIS-014
- Conditions
- Cystoscope, Lower Urinary Tract Symptoms, Bladder Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Ambu A/SIndustry (pharma, biotech, devices)
- Collaborators
- QserveCRO
- Study start
- 21 Jul 2020 (actual)
- Primary completion
- 7 Apr 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 10 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 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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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
| Arm | Type | Receives |
|---|---|---|
| Flexible cystoscopy | Other | Device: Flexible cystoscopy50% of the patients undergo flexible diagnostic cystoscopy; 50% of the patients undergo flexible cystoscopy intervention with endoscopic accessories. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| Flexible cystoscopyTreatment with the investigational device: Ambu® aScope™ 4 Cysto | Device | Flexible cystoscopy |
Primary outcome
Performance of the cystoscope
Time frame: 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)
5 secondary outcomes
Overall performance
Time frame: follow up immediately after procedure
Procedure time
Time frame: follow up immediately after procedure
Patient Tolerance
Time frame: follow up immediately after procedure
Adverse events
Time frame: follow up immediately after procedure
Adverse events
Time frame: follow-up at 7 days 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.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flexible cystoscopy in people with Cystoscope and Lower Urinary Tract Symptoms, run by Ambu A/S at 2 sites in 2 countries.
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 3 inclusion and 7 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 2 sites in Denmark, Netherlands. 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 the cystoscope (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.