Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Multi-Center Comparison of Dual Lumen Versus Single Lumen Ureteroscopes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02123082
Recruitment Status : Recruiting
First Posted : April 25, 2014
Last Update Posted : January 18, 2018
Sponsor:
Information provided by (Responsible Party):
Jaime Landman, University of California, Irvine

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.


Condition or disease Intervention/treatment Phase
Urolithiasis Device: Storz single Lumen Ureteroscope Device: Dual Lumen Ureteroscope Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Multi-Center Comparison of Dual Lumen Versus Single Lumen Ureteroscopes
Study Start Date : April 2014
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2019

Arm Intervention/treatment
Single-Lumen Ureteroscope
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 Ureteroscope
Single lumen, flexible scope for ureteroscopies
Other Name: Storz

Device: Dual Lumen Ureteroscope
Dual lumen, flexible scope for ureteroscopies
Other Name: Wolf Cobra

Experimental: Dual Lumen Ureteroscope
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 Ureteroscope
Single lumen, flexible scope for ureteroscopies
Other Name: Storz

Device: Dual Lumen Ureteroscope
Dual lumen, flexible scope for ureteroscopies
Other Name: Wolf Cobra




Primary Outcome Measures :
  1. Time [ Time Frame: Day 1 (Day of procedure) ]
    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.


Secondary Outcome Measures :
  1. Complications [ Time Frame: Days 1-30 ]
    The secondary outcomes are going to be requirement for a second procedure, intraoperative complications, immediate postoperative complications, postoperative complications within 30 days of the procedure.

  2. Time [ Time Frame: Days 1-30 ]
    Total Ureteroscopy time, stone fragmentation time, stone clearance time and overall procedure time.

  3. Device efficacy [ Time Frame: Procedure day ]
    Surgeon's opinion and comfort (scale 1-10), visibility (1-10), and ureteroscope durability.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02123082


Contacts
Layout table for location contacts
Contact: Jaime Landman, MD 714-456-3330 landmanj@uci.edu

Locations
Layout table for location information
United States, California
University of California, Irvine Medical Center Recruiting
Orange, California, United States, 92868
Contact: Victor B Huynh, BS    714-456-8176    vbhuynh@uci.edu   
Principal Investigator: Jaime Landman, MD         
Sponsors and Collaborators
University of California, Irvine
Investigators
Layout table for investigator information
Principal Investigator: Jaime Landman, MD University of California, Irvine

Layout table for additonal information
Responsible Party: Jaime Landman, Professor of Urology and Radiology, Chairman of Urology, University of California, Irvine
ClinicalTrials.gov Identifier: NCT02123082     History of Changes
Other Study ID Numbers: 2014-1060
First Posted: April 25, 2014    Key Record Dates
Last Update Posted: January 18, 2018
Last Verified: January 2018
Keywords provided by Jaime Landman, University of California, Irvine:
Urolithiasis
Kidney stones
Ureteral Obstruction
Ureteroscopes
Ureteroscopies
Additional relevant MeSH terms:
Layout table for MeSH terms
Urolithiasis
Urologic Diseases