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

July 16, 2017 updated by: Guohua Zeng

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

The aim of this trial is to compare the safety, efficacy and cost effectiveness of the three types of scopes.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

450

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 Contact

Study Contact Backup

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 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

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
Experimental: single-use digital ureteroscope
Participants under this arm will undergo retrograde intrarenal surgery (RIRS) procedure under the single use digital ureteroscope.
Procedure: single use digital ureteroscope
All participants in this arm will undergo RIRS using a single use digital ureteroscope.
Experimental: reusable fiberoptic ureteroscopes
Participants under this arm will undergo the RIRS procedure under the reusable fiberoptic ureteroscope
Procedure: reusable fiberoptic ureteroscope
All participants under this arm will undergo RIRS using a reusable fiberoptic ureteroscope
Experimental: reusable digital flexible ureteroscopes
Participants under this arm will undergo the RIRS procedure under the reusable digital flexible ureteroscope.
Procedure: reusable digital flexible ureteroscope
All participants under this arm will undergo RIRS using reusable digital flexible ureteroscope

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cost of surgery
Time Frame: intraoperative
the total cost of the procedure
intraoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stone free rate
Time Frame: 1month after surgery
1month after surgery
stone free rate
Time Frame: 3months after surgery
3months after surgery
complication rates
Time Frame: upto 3months
upto 3months
operative time
Time Frame: intraoperative
intraoperative
operator's satisfaction with the scope
Time Frame: intraoperative
on the scope or 1-10
intraoperative

Collaborators and Investigators

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

Sponsor

Guohua Zeng

Collaborators

Dr. Lufti KIRDAR Kartal Research and training Hospital, Instanbul, Turkey
Siloam St.Trudpert Hospital

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 (Anticipated)

August 1, 2017

Primary Completion (Anticipated)

September 1, 2020

Study Completion (Anticipated)

September 1, 2020

Study Registration Dates

First Submitted

July 1, 2017

First Submitted That Met QC Criteria

July 16, 2017

First Posted (Actual)

July 18, 2017

Study Record Updates

Last Update Posted (Actual)

July 18, 2017

Last Update Submitted That Met QC Criteria

July 16, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Scopes compared

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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