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Comparing Treatment of Urolithiasis Between Disposable and Reusable Ureteroscope

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03040466
Recruitment Status : Completed
First Posted : February 2, 2017
Results First Posted : October 1, 2020
Last Update Posted : October 1, 2020
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Kidney Calculi Ureter Calculi Device: reusable fiberoptic ureteroscope Device: disposable digital ureteroscope Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will be assigned to each 3 type of ureteroscope and receive the flexible ureteroscopy. In each ureteroscopy, only one type of ureteroscope will be used; therefore this study will be parallel model.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial Comparing Disposable to Reusable Flexible Ureteroscope for Treatment of Upper Urinary Tract Stone
Actual Study Start Date : August 2014
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Number of Participants That Are Stone Free [ Time Frame: three month after surgery ]
    this will be determined by either CT, US, or KUB

  2. Number of Participants With Complications [ Time Frame: from during the surgery to three months after the surgery ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

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): NCT03040466


Locations
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United States, California
University of California, San Francisco
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
Investigators
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Principal Investigator: Thomas Chi, MD Urology, University of California San Francisco
Publications of Results:
Other Publications:

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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03040466    
Other Study ID Numbers: 16-20844
First Posted: February 2, 2017    Key Record Dates
Results First Posted: October 1, 2020
Last Update Posted: October 1, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by University of California, San Francisco:
ureteroscopy
flexible ureteroscope
randomized controlled trial
Additional relevant MeSH terms:
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Kidney Calculi
Nephrolithiasis
Calculi
Pathological Conditions, Anatomical
Kidney Diseases
Urologic Diseases
Urolithiasis
Urinary Calculi