NCT02123082

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
156

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 26, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 25, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

July 2, 2014

Completed
6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2021

Completed
Last Updated

March 13, 2025

Status Verified

March 1, 2025

Enrollment Period

6.8 years

First QC Date

March 26, 2014

Last Update Submit

March 11, 2025

Conditions

Urolithiasis

Keywords

UrolithiasisKidney stonesUreteral ObstructionUreteroscopesUreteroscopies

Outcome Measures

Primary Outcomes (1)

  • Time

    The primary outcome of the proposed study will be the procedure time in minutes measured from the start of the endoscopic access to the end of the procedure including complete fragmentation and stone fragment removal.

    Day 1 (Day of procedure)

Secondary Outcomes (3)

  • Complications

    Days 1-30

  • Time

    Days 1-30

  • Device efficacy

    Procedure day

Study Arms (2)

Single-Lumen Ureteroscope

OTHER

Subjects enrolled in this study arm will have their procedure performed using the single lumen ureteroscopes. This scope is currently employed in clinical practice, including at UC Irvine Medical Center.

Device: Storz single Lumen UreteroscopeDevice: Dual Lumen Ureteroscope

Dual Lumen Ureteroscope

EXPERIMENTAL

Subjects enrolled in this study arm will have their procedure performed using the dual lumen ureteroscopes. This scope is currently employed in clinical practice, including at UC Irvine Medical Center.

Device: Storz single Lumen UreteroscopeDevice: Dual Lumen Ureteroscope

Interventions

Storz single Lumen UreteroscopeDEVICE

Single lumen, flexible scope for ureteroscopies

Also known as: Storz
Dual Lumen UreteroscopeSingle-Lumen Ureteroscope
Dual Lumen UreteroscopeDEVICE

Dual lumen, flexible scope for ureteroscopies

Also known as: Wolf Cobra
Dual Lumen UreteroscopeSingle-Lumen Ureteroscope

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients \>18 years old.
  • Patients with \<2 cm total burden of renal or ureteral stones eligible for flexible ureteroscopic lithotripsy.

You may not qualify if:

  • Patients \<18 years old.
  • Patients who are not able to give consent for study
  • Patients with active urinary tract infection
  • Pregnant women
  • Patients who have had ureteroscopy, SWL or PCNL for the same stone on the ipsilateral kidney

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, Irvine Medical Center

Orange, California, 92868, United States

Location

MeSH Terms

Conditions

UrolithiasisKidney CalculiUreteral Obstruction

Condition Hierarchy (Ancestors)

Urologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesNephrolithiasisKidney DiseasesUrinary CalculiCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsUreteral Diseases

Study Officials

  • Jaime Landman, MD

    University of California, Irvine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Urology and Radiology

Study Record Dates

First Submitted

March 26, 2014

First Posted

April 25, 2014

Study Start

July 2, 2014

Primary Completion

April 1, 2021

Study Completion

April 1, 2021

Last Updated

March 13, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)