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A Study Comparing a Disposable Flexible Cystoscope With Reusable Scopes in Adult Patients.

NCT06422312 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2025-04-04

No results posted yet for this study

Summary

This study will compare the time required for a cystoscopy procedure in adult participants using the Redpine® Rflex endo(trademark) High-Definition Cystoscope or the site's standard of care reusable flexible cystoscope in participants requiring urethral stent removal.

Conditions

  • Bladder Cancer
  • Bladder Stone
  • Bladder Outlet Obstruction
  • Renal Stone
  • Renal Disease

Interventions

DEVICE

Cystoscopy with RedPine flexible disposable cystoscope

Use of a disposable flexible cystoscope to visualize the urethra and bladder, take biopsies, and remove stents.

DEVICE

Cystoscopy with standard of care flexible reusable scope

Use of a reusable flexible cystoscope to visualize the urethra and bladder, take biopsies, and remove stents

Sponsors & Collaborators

  • University of Texas Southwestern Medical Center

    collaborator OTHER

  • University of Washington

    collaborator OTHER

  • Penn State University

    collaborator OTHER

  • Guangzhou Red Pine Medical Instrument Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Yair Lotan, MD · UT Southwestern Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
120 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-31
Primary Completion
2025-01-31
Completion
2025-07-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06422312 on ClinicalTrials.gov