Bladder Tumor
Conditions
Brief 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.
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.
Interventions
DEVICEUro-C (Use of new cystoscope)
Diagnostic cystoscopic procedure of the urethra and bladder
Sponsors
UroSee Corporation
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 90 Years
Healthy volunteers
Yes
Inclusion criteria
1. Otherwise healthy adult (18 years of age or older) women presenting for cystoscopy for diagnostic purposes; and 2. Ambulatory and able to undergo routine cystoscopy in the lithotomy position.
Exclusion criteria
1. History of prior bladder/urethral surgery other than TURBT; or 2. History of interstitial cystitis; or 3. Presence of urinary tract infection (UTI); or 4. Gross hematuria; or 5. History of pelvic radiation therapy; or 6. Procidentia; or 7. Unable to read, understand, and/or provide a ranking of pain level during the procedure; or 8. Unable or unwilling to provide consent to participation in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of the utility and performance of the cystoscope by the physician | during the procedure | Ranking with Likert Scale on ease of advancement, visibility of tissue and structures, and removal of the device |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient tolerance of the procedure | during and within 5 days after the procedure | Assess level of discomfort or adverse event associated with the procedure by the subject using the Likert Scale |
Countries
United States
Contacts
Primary ContactThomas Lawson, PhD
Backup ContactBela Denes, MD
Outcome results
None listed