NCT02922868

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

The increasing costs in health care and enhanced infection control requirements necessitate the efficient and reliable use of frequently used techniques like cystoscopy. The health economics of cystoscopy are dependent on maintaining low levels of post-cystoscopy sequelae like urinary tract infection (UTI) and its potential precursors, significant asymptomatic bacteriuria and leukocytosis. Another key component of the economics and efficiency of cystoscopy is the time and cost related to the reprocessing of these devices in preparation for re-use. The use of disposable endoscope sheaths may limit the need for high level disinfection (HLD) between procedures and reduce reprocessing time and potentially prolong the cystoscope lifespan. The rationale for this study is to determine if a sheathed cystoscopy system would provide the desired cost and efficiency advantages compared to procedures done with non-sheathed cystoscopes. This is a prospective, randomized, parallel group, single center clinical trial to assess the clinical outcomes, practice efficiency and health economics of the use of sheathed cystoscopes (EndoSheath® System) compared to using standard (non-sheathed) cystoscopes. The study will evaluate the infection control (via the change in bacteriuria), clinical practice efficiency and costs of the EndoSheath technology with CST 5000 scope compared to standard cystoscopy with Olympus Visera Elite OTV-S190 digital flexible scope. There will be 30 subjects in the control group undergoing cystoscopy with the standard scope at the clinic, the Olympus Visera Elite, and 30 subjects in the study group undergoing cystoscopy with the EndoSheath system. The study is designed as a prospective, randomized controlled trial. There will be no active blinding of clinicians or subjects; however, it is anticipated that most subjects will be unaware of differences in the cystoscopy equipment that will be utilized in their routine procedures.

Conditions

• Bacteriuria

Interventions

Type	Name	Description
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

Timeline

• Start date: 2016-03-01
• Primary completion: 2016-12-01
• Completion: 2016-12-01
• First posted: 2016-10-04
• Last updated: 2018-09-12
• Results posted: 2018-02-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study