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Assessment of the Uro-C Cystoscope for Use in Diagnostic Cystoscopy Procedures

NCT ID: NCT03331705

Last Updated: 2017-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-11-05

Study Completion Date

2018-09-05

Brief Summary

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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

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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

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Bladder Tumor

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Use of new cystoscope

Patients in which the cystoscope is used.

Uro-C (Use of new cystoscope)

Intervention Type DEVICE

Diagnostic cystoscopic procedure of the urethra and bladder

Interventions

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Uro-C (Use of new cystoscope)

Diagnostic cystoscopic procedure of the urethra and bladder

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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UroSee Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bela Denes, MD

Role: STUDY_DIRECTOR

UroSee Corporation

Locations

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Las Vegas Urology

Las Vegas, Nevada, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Thomas Lawson, PhD

Role: CONTACT

Phone: 510 206 1794

Email: [email protected]

Bela Denes, MD

Role: CONTACT

Phone: 949 378 0268

Email: [email protected]

Facility Contacts

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Vijay Goli, MD

Role: primary

Marian Bertola, RN

Role: backup

Other Identifiers

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16-001

Identifier Type: -

Identifier Source: org_study_id