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Single-use Digital Flexible Ureteroscope vs Nondisposable Fiber Optic vs Digital Ureteroscope

Primary Purpose

Urolithiasis

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
single use digital ureteroscope
reusable fiberoptic ureteroscope
reusable digital flexible ureteroscope
Sponsored by
Guohua Zeng
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urolithiasis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Aged 18-70 years
  2. American society of Anesthesiology (ASA) score 1 and 2
  3. Renal or upper ureteral stone of diameter ≤ 2.0 cm

Exclusion Criteria:

  1. Ureteral stricture, renal or ureteral deformity
  2. Pregnancy
  3. Patients with chronic kidney disease, CKD (serum creatine> 177 umol/L)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Experimental

    Arm Label

    single-use digital ureteroscope

    reusable fiberoptic ureteroscopes

    reusable digital flexible ureteroscopes

    Arm Description

    Participants under this arm will undergo retrograde intrarenal surgery (RIRS) procedure under the single use digital ureteroscope.

    Participants under this arm will undergo the RIRS procedure under the reusable fiberoptic ureteroscope

    Participants under this arm will undergo the RIRS procedure under the reusable digital flexible ureteroscope.

    Outcomes

    Primary Outcome Measures

    cost of surgery
    the total cost of the procedure

    Secondary Outcome Measures

    Stone free rate
    stone free rate
    complication rates
    operative time
    operator's satisfaction with the scope
    on the scope or 1-10

    Full Information

    First Posted
    July 1, 2017
    Last Updated
    July 16, 2017
    Sponsor
    Guohua Zeng
    Collaborators
    Dr. Lufti KIRDAR Kartal Research and training Hospital, Instanbul, Turkey, Siloam St.Trudpert Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03220516
    Brief Title
    Single-use Digital Flexible Ureteroscope vs Nondisposable Fiber Optic vs Digital Ureteroscope
    Official Title
    A Prospective Randomized Study Comparing Single-use Digital Flexible Ureteroscope, Nondisposable Fiber Optic and Digital Ureteroscope in Treatment of Upper Urinary Stone Less Than 2 cm
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    August 2017 (Anticipated)
    Primary Completion Date
    September 2020 (Anticipated)
    Study Completion Date
    September 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Guohua Zeng
    Collaborators
    Dr. Lufti KIRDAR Kartal Research and training Hospital, Instanbul, Turkey, Siloam St.Trudpert Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    The aim of this trial is to compare the safety, efficacy and cost effectiveness of the three types of scopes.
    Detailed Description
    With the advancement of technology, flexible ureteroscopy (f-URS) has become an attractive option for surgical management of kidney stones. However, the durability of flexible ureteroscope still remains a major concern. Due to the high cost and limited durability, the cost-benefit of non-disposable flexible ureteroscope continues to be the most important factor for initiating and maintaining fURS programs worldwide, especially in the developing countries. Nowadays, disposable digital flexible ureteroscopes are available, offering an improved image resolution, no need for sterilization and repair, and more economic.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Urolithiasis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    450 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    single-use digital ureteroscope
    Arm Type
    Experimental
    Arm Description
    Participants under this arm will undergo retrograde intrarenal surgery (RIRS) procedure under the single use digital ureteroscope.
    Arm Title
    reusable fiberoptic ureteroscopes
    Arm Type
    Experimental
    Arm Description
    Participants under this arm will undergo the RIRS procedure under the reusable fiberoptic ureteroscope
    Arm Title
    reusable digital flexible ureteroscopes
    Arm Type
    Experimental
    Arm Description
    Participants under this arm will undergo the RIRS procedure under the reusable digital flexible ureteroscope.
    Intervention Type
    Procedure
    Intervention Name(s)
    single use digital ureteroscope
    Intervention Description
    All participants in this arm will undergo RIRS using a single use digital ureteroscope.
    Intervention Type
    Procedure
    Intervention Name(s)
    reusable fiberoptic ureteroscope
    Intervention Description
    All participants under this arm will undergo RIRS using a reusable fiberoptic ureteroscope
    Intervention Type
    Procedure
    Intervention Name(s)
    reusable digital flexible ureteroscope
    Intervention Description
    All participants under this arm will undergo RIRS using reusable digital flexible ureteroscope
    Primary Outcome Measure Information:
    Title
    cost of surgery
    Description
    the total cost of the procedure
    Time Frame
    intraoperative
    Secondary Outcome Measure Information:
    Title
    Stone free rate
    Time Frame
    1month after surgery
    Title
    stone free rate
    Time Frame
    3months after surgery
    Title
    complication rates
    Time Frame
    upto 3months
    Title
    operative time
    Time Frame
    intraoperative
    Title
    operator's satisfaction with the scope
    Description
    on the scope or 1-10
    Time Frame
    intraoperative

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Aged 18-70 years American society of Anesthesiology (ASA) score 1 and 2 Renal or upper ureteral stone of diameter ≤ 2.0 cm Exclusion Criteria: Ureteral stricture, renal or ureteral deformity Pregnancy Patients with chronic kidney disease, CKD (serum creatine> 177 umol/L)
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Wei Zhu, PhD
    Phone
    008613622754991
    Email
    doczw1989@126.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Irene Ketegwe, MBBS
    Phone
    008613725186310
    Email
    tanzaniaheping@126.com

    12. IPD Sharing Statement

    Learn more about this trial

    Single-use Digital Flexible Ureteroscope vs Nondisposable Fiber Optic vs Digital Ureteroscope

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