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Assessment of Infection Control, Practice Efficiency, and Health Economics of Sheathed Versus Standard Cystoscopy

NCT02922868 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2018-09-12

Study results available
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Summary

The purpose of this research study is to compare the effectiveness and efficiency of using a sterile sheath (EndoSheath®) during cystoscopy versus a standard scope.

Conditions

  • Bacteriuria

Interventions

DEVICE

EndoSheath CST-5000 Scope

Cystoscopic procedures will be performed using the EndoSheath CST-5000 Scope.

DEVICE

Olympus Visera Elite OTV-S190 Scope

Cystoscopic procedures will be performed using the Olympus Visera Elite OTV-S190 Scope

Sponsors & Collaborators

  • Cogenix Medical Corporation

    collaborator INDUSTRY

  • Wake Forest University Health Sciences

    lead OTHER

Principal Investigators

  • Gopal H Badlani, M.D. · Wake Forest University Health Sciences

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2016-12-31
Completion
2016-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT02922868 on ClinicalTrials.gov