Bladder TumorNCT03331705
Assessment of the Uro-C Cystoscope for Use in Diagnostic Cystoscopy Procedures
An observational study of Bladder Tumor, run by UroSee Corporation at 1 site in United States.
Trial summary
This is a prospective, multicenter, single-arm, open-label clinical usability study in subjects who are candidates for office diagnostic cystoscopy. The primary objective of this initial device assessment is to evaluate the performance of a new cystoscope for direct visualization of the urethra and bladder. Read more about this study
- Who is it for?
- Ages 18 to 90 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Bladder Tumor
- What is being tested?
- Uro-C (Use of new cystoscope)
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Nov 2016to 5 Sep 2018
- Phase
- Observational
- 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 to 90 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Females requiring a diagnostic cystoscopic procedure
Who may be able to join
- Otherwise healthy adult (18 years of age or older) women presenting for cystoscopy for diagnostic purposes; and
- Ambulatory and able to undergo routine cystoscopy in the lithotomy position.
Who cannot join
- History of prior bladder/urethral surgery other than TURBT; or
- History of interstitial cystitis; or
- Presence of urinary tract infection (UTI); or
- Gross hematuria; or
- History of pelvic radiation therapy; or
- Procidentia; or
- Unable to read, understand, and/or provide a ranking of pain level during the procedure; or
- Unable or unwilling to provide consent to participation in the study.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Las Vegas Urology
Las Vegas, Nevada, 89128
Vijay Goli, MD, 702-233-0727
Marian Bertola, RN, 702 385 4343
About this study
Official title: Evaluation of the Performance of a Disposable Cystoscope System for Direct Visualization of the Urethra and Bladder
This is a prospective, multicenter, single-arm, open-label clinical usability study in subjects who are candidates for office diagnostic cystoscopy. The primary objective of this initial device assessment is to evaluate the performance of a new cystoscope for direct visualization of the urethra and bladder.
Read the detailed description
A new cystoscope has been designed for female diagnostic cystoscopy, with a focus on promoting patient comfort, tolerability and safety while improving office efficiency. The cystoscope, named the Uro-C, is light-weight, ergonomic, handheld, battery-operated portable system that integrates a disposable cannula with a reusable handle that contains video electronics, is wireless capable, and has a liquid crystal display (LCD) monitor. Cystoscopy with the new system is performed in a standard manner to cystoscopy with currently available endoscopes, so risks are no different than when currently available endoscopes are used.
This is a prospective, multi-center, single-arm, open-label clinical usability study in subjects who are candidates for office diagnostic cystoscopy. The primary objective of this initial device assessment is to evaluate the performance of the cystoscope for direct visualization of the urethra and bladder.
- Conditions
- Bladder Tumor
- Being tested
- Uro-C (Use of new cystoscope)
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Uro-C (Use of new cystoscope)Device
Diagnostic cystoscopic procedure of the urethra and bladder
| Study group | Role | What they receive |
|---|---|---|
| Use of new cystoscope | Patients in which the cystoscope is used. Receives: Device: Uro-C (Use of new cystoscope) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the utility and performance of the cystoscope by the physician
Ranking with Likert Scale on ease of advancement, visibility of tissue and structures, and removal of the device
Measured: during the procedure
Secondary outcomes (1)
Patient tolerance of the procedure
Assess level of discomfort or adverse event associated with the procedure by the subject using the Likert Scale
Measured: during and within 5 days after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study start5 Nov 2016
- Primary completion5 Jul 2018 (estimated)
- Study completion5 Sep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder TumorStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UroSee Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bela Denes, MD, Study director, UroSee Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03331705
- Sponsor's protocol ID
- 16-001
- Status last verified
- Oct 2017
- First submitted
- 26 Oct 2017
- Last updated
- 6 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Performance of a Disposable Cystoscope System for Direct Visualization of the Urethra and Bladder
- ClinicalTrials.gov ID
- NCT03331705
- Acronym / sponsor ID
- 16-001
- Conditions
- Bladder Tumor
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- UroSee CorporationIndustry (pharma, biotech, devices)
- Study start
- 5 Nov 2016
- Primary completion
- 5 Jul 2018 (estimated)
- Study completion
- 5 Sep 2018 (estimated)
- First posted
- 6 Nov 2017 (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.
This is a prospective, multicenter, single-arm, open-label clinical usability study in subjects who are candidates for office diagnostic cystoscopy. The primary objective of this initial device assessment is to evaluate the performance of a new cystoscope for direct visualization of the urethra and bladder.
Detailed description
A new cystoscope has been designed for female diagnostic cystoscopy, with a focus on promoting patient comfort, tolerability and safety while improving office efficiency. The cystoscope, named the Uro-C, is light-weight, ergonomic, handheld, battery-operated portable system that integrates a disposable cannula with a reusable handle that contains video electronics, is wireless capable, and has a liquid crystal display (LCD) monitor. Cystoscopy with the new system is performed in a standard manner to cystoscopy with currently available endoscopes, so risks are no different than when currently available endoscopes are used.
This is a prospective, multi-center, single-arm, open-label clinical usability study in subjects who are candidates for office diagnostic cystoscopy. The primary objective of this initial device assessment is to evaluate the performance of the cystoscope for direct visualization of the urethra and bladder.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Use of new cystoscope | – | Device: Uro-C (Use of new cystoscope)Patients in which the cystoscope is used. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Females requiring a diagnostic cystoscopic procedure
Key inclusion criteria (2 listed)
- Otherwise healthy adult (18 years of age or older) women presenting for cystoscopy for diagnostic purposes; and
- Ambulatory and able to undergo routine cystoscopy in the lithotomy position.
Key exclusion criteria (8 listed)
- History of prior bladder/urethral surgery other than TURBT; or
- History of interstitial cystitis; or
- Presence of urinary tract infection (UTI); or
- Gross hematuria; or
- History of pelvic radiation therapy; or
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 |
|---|---|---|
| Uro-C (Use of new cystoscope)Diagnostic cystoscopic procedure of the urethra and bladder | Device | Use of new cystoscope |
Primary outcome
Assessment of the utility and performance of the cystoscope by the physician
Time frame: during the procedure
Ranking with Likert Scale on ease of advancement, visibility of tissue and structures, and removal of the device
1 secondary outcome
Patient tolerance of the procedure
Time frame: during and within 5 days after the procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2017.
- Individual participant dataSharing planned: Undecided
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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.
Bela Denes, MD study director
UroSee Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bladder Tumor, run by UroSee Corporation at 1 site in United States.
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 2 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 6 Nov 2017. 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 United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thomas Lawson, PhD (510 206 1794, thom@urosee.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the utility and performance of the cystoscope by the physician (time frame: during the 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 6 Nov 2017.