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Impact Ureteral Sheath Design During Ureteroscopy

NCT03349099 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 95

Last updated 2018-01-23

Study results available
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Summary

The purpose of this study is to assess whether one of two ureteral access sheaths is safer for patients undergoing ureteroscopy. Both sheaths are FDA approved devices and commercially available. The investigators will compare the ability of sheaths to access the kidney through the ureter and will compare damage done to the ureter after completion of the procedure. Access sheaths are standard of care for this procedure; this study seeks to optimize outcomes for patients.

Patients undergoing ureteroscopy who do not have ureteral stents in place and who have not had an ipsilateral procedure within 90 days will be recruited and consented.

Conditions

  • Renal Stone
  • Nephrolithiasis
  • Urolithiasis

Interventions

DEVICE

Cook Flexor

ureteral access sheath

DEVICE

Boston Scientific Navigator

ureteral access sheath

Sponsors & Collaborators

  • The Cleveland Clinic

    lead OTHER

Principal Investigators

  • Manoj Monga, MD · Urologist

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-06-27
Primary Completion
2016-07-31
Completion
2016-07-31
FDA Device
Yes

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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 NCT03349099 on ClinicalTrials.gov