Comparing Treatment of Urolithiasis Between Disposable and Reusable Ureteroscope

September 9, 2020 updated by: University of California, San Francisco

Randomized Controlled Trial Comparing Disposable to Reusable Flexible Ureteroscope for Treatment of Upper Urinary Tract Stone

Reusable flexible ureteroscopes are widely used to treat various upper urinary tract diseases including urinary stones. However, they require a long turnover time between procedures because of the sterilization process. Moreover, repeated use of a scope ultimately deteriorates its image quality which leads to a high maintenance cost in the long-term. A disposable digital flexible ureteroscope was released in the United States in January 2016, offering an improved image resolution, new scope performance characteristics with every case, and no need for sterilization and repair. Preliminary data from our center has demonstrated that disposable scopes shorten operative time by 25% compared to reusable fiberoptic scope and are associated with a 2/3 reduction in procedural complication rate. Therefore, treatment with disposable scopes may be more effective for patients and facilitate cost management within the hospital.

Here, we propose a three-armed, prospective randomized study, comparing treatment outcomes between disposable digital, reusable fiberoptic, and reusable digital flexible ureteroscopes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a single center, prospective, randomized controlled pragmatic clinical trial designed to compare between disposable, reusable fiberoptic, and reusable digital ureteroscopes in upper urinary tract stone treatment efficacy. Three hundred subjects with kidney and/or ureteral stones are planned to recruit for the study. All subjects will be computer sequence-randomized into having their ureteroscopic treatment performed with a disposable (LithoVue™), reusable fiberoptic (URF-P6™), or reusable digital (URF-V2™) flexible ureteroscope. Patient's demographics, physical, laboratory, and image findings will be collected before surgery. These clinical data are already being collected as part of an ongoing registry study. Perioperative timing as well as operator's satisfaction and fatigue and need for a second ureteroscope during the case will be recorded during the treatment course. Other clinical data will be collected at days 7, 30, 90, 180 after surgery. The condition of the used ureteroscopes will be tracked and recorded to confirm the repair rate.

Screening data will be reviewed to determine subject eligibility. Subjects who meet all inclusion criteria and none of the exclusion criteria will be entered into the study.

The following surgical treatment will be used similarly for all three randomized arms and represents standard of case therapy:

Ureteroscopic stone removal Under general anesthesia, the patient is placed in the lithotomy position. All procedures are performed under direct videoscopic and fluoroscopic guidance. Fluoroscopic screening is utilized using a mobile multidirectional C-arm fluoroscopy unit. Initially, a safety guide-wire is placed into the renal pelvis, followed by a ureteral access sheath as needed to maintain low intra-renal pressure and to facilitate the procedures. Using a flexible ureteroscope, renal or ureteral stones are identified and fragmented with a holmium YAG laser. Basket extraction of residual fragments is done until visual complete clearance of stone fragments is achieved.

After ureteroscopy is done and stone clearance is achieved, a ureteral stent is placed at the end of the procedure to drain the kidney for 2-21 days if it is clinically indicated.

The total duration of the study is expected to be one year for subject recruitment and one year and six months for final subject follow-up.

Study Type

Interventional

Enrollment (Actual)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94143
        • University of California, San Francisco

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Male or female ≥ 18 years of age at their first clinical visit.
  2. Patients with either unilateral or bilateral upper urinary tract stone of any size and location, treatable by flexible ureteroscopy, diagnosed by preoperative ultrasound, computed tomography or plain radiographic imaging
  3. Patients being able and willing to provide consent.

Exclusion Criteria:

  1. Serious illness likely to cause death within the next 5 years, so as to exclude significant metabolic derangements that might lead to adverse surgical outcome.
  2. Pregnancy.
  3. Staged ureteroscopic procedure.
  4. Antegrade flexible ureteroscopy.
  5. Dual procedures (ureteroscopy concurrently performed with other operations).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: reusable fiberoptic ureteroscope
For this arm, participants will receive the ureteroscopy for their kidney and ureter stones using reusable fiberoptic flexible ureteroscope (URF-P6, Olympus). The surgical method of the ureteroscopy will be a standard fashion same as other arms.
Device: reusable fiberoptic ureteroscope
We will use reusable fiberoptic ureteroscopes for the treatment of kidney and ureter stones.
Experimental: disposable digital ureteroscope
For this arm, participants will receive the ureteroscopy for their kidney and ureter stones using disposable digital flexible ureteroscope (LithoVue, Boston Scientific). The surgical method of the ureteroscopy will be a standard fashion same as other arms.
Device: disposable digital ureteroscope
We will use disposable digital ureteroscopes for the treatment of kidney and ureter stones.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall Procedure Time
Time Frame: at the surgery day, this will be a duration that each ureteroscopy is performed for a patient, assessed between 10 and 120 minutes
at the surgery day, this will be a duration that each ureteroscopy is performed for a patient, assessed between 10 and 120 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants That Are Stone Free
Time Frame: three month after surgery
this will be determined by either CT, US, or KUB
three month after surgery
Number of Participants With Complications
Time Frame: from during the surgery to three months after the surgery
from during the surgery to three months after the surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Investigators

  • Principal Investigator: Thomas Chi, MD, Urology, University of California San Francisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2014

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

January 23, 2017

First Submitted That Met QC Criteria

January 31, 2017

First Posted (Estimate)

February 2, 2017

Study Record Updates

Last Update Posted (Actual)

October 1, 2020

Last Update Submitted That Met QC Criteria

September 9, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16-20844

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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