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A Novel Urinary Access System for Universal Transcatheter Cystoscopy at The Time of Hysterectomy

NCT03503175 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 364

Last updated 2020-07-28

No results posted yet for this study

Summary

Cystoscopy is a commonly performed procedure after gynecologic surgery, however, its use may increase patients' risk for acquiring urinary tract infections due to urinary tract instrumentation entry and reentry of the lower urinary tract with the cystoscope and foley catheter. Use of a novel multi-channel transurethral bladder catheter that allows for cystoscopy through a specialized port will permit cystoscopy to be performed without catheter removal. This may allow for intraoperative detection of urinary tract injuries with a reduction in both urethral manipulation and hospital-associated urinary tract infections. Other potential benefits may include a shorter procedure time and ease of use for providers.

Conditions

  • Hysterectomy

Interventions

DEVICE

Novel urinary access system (CystoSureTM)

CystoSureTM is a silicone device that was developed by surgeons to enable easy and standardized cystoscopy. The design of the CystoSureTM catheter has separate channels for draining the bladder and performing cystoscopy, so doctors can perform a cystoscopy without removing the catheter (which can, as described above, potentially lead to a UTI).

DEVICE

Standard Foley catheter

Participants randomized to this arm will receive a standard Foley catheter and standard rigid cystoscopy.

Sponsors & Collaborators

  • Atlantic Health System

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-26
Primary Completion
2022-02-01
Completion
2022-03-01
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 NCT03503175 on ClinicalTrials.gov