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Multi-Center Comparison of Dual Lumen Versus Single Lumen Ureteroscopes

NCT02123082 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 156

Last updated 2025-03-13

No results posted yet for this study

Summary

Urolithiasis (kidney stones) is a common disease process affecting people all across the world. Usually, if the stone size is small, it is able to pass through the urinary system and exit the bladder on its own with no treatment. However, when the size of the stone is bigger, it can get trapped in the kidney or the ureter, causing significant pain for the patient and potentially obstructing urine flow. If this occurs, surgical treatment is necessary for the removal of the stone. The surgical procedure often employed involves the use of a ureteroscope, which is a device that includes a camera and channels for working instruments such as a grasper and laser fiber to be placed during a procedure. Ureteroscopes that are currently in use are flexible and have the ability to treat stones that may otherwise be inaccessible in the kidney. Most flexible ureteroscopes in clinical use currently only have one channel therefore only allowing one instrument to be used at a time. Recently, a new type of ureteroscope has been introduced in the market that offers the advantage of having two working channels where two instruments can be inserted for use during stone treating procedure. This can potentially decrease procedure time for patients affected by kidney stones.

The purpose of this research is to compare the efficacy and safety of the ureteroscopes that have only one channel for instrument insertion with the newer ureteroscope that has two channels for utilization during stone treatment.

Conditions

  • Urolithiasis

Interventions

DEVICE

Storz single Lumen Ureteroscope

Single lumen, flexible scope for ureteroscopies

DEVICE

Dual Lumen Ureteroscope

Dual lumen, flexible scope for ureteroscopies

Sponsors & Collaborators

  • University of California, Irvine

    lead OTHER

Principal Investigators

  • Jaime Landman, MD · University of California, Irvine

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-07-02
Primary Completion
2021-04-30
Completion
2021-04-30
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 NCT02123082 on ClinicalTrials.gov