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Comparison Between Different Types of Flexible Ureteroscopes

ConditionsRenal CalculiNephrolithiasis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorAin Shams University

About this trial

The current study aims to compare the performance of three distinct single-use digital flexible ureteroscope types in terms of cost-effectiveness, postoperative complications, operating time, and stone-free rates (SFRs).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients aged 18 to 60 years.

Presence of renal stones measuring less than 20 millimeters (mm).

Disqualifiers

Renal stones larger than 20 millimeters (mm).

Uncontrolled bleeding disorders or coagulopathies.

Active urinary tract infection.

Renal failure.

Trial design

Design model

Parallel

Treatments tested in this trial

  • LithoVue™ (Boston Scientific Corporation)

    Device

    Participants randomized to this arm will undergo retrograde intrarenal surgery (RIRS) for renal stone management using the LithoVue™ single-use digital flexible ureteroscope.

  • WiScope® (OTU Medical Inc. (Silicon Valley, USA))

    Device

    Participants randomized to this arm will undergo retrograde intrarenal surgery (RIRS) for renal stone management using the WiScope single-use digital flexible ureteroscope.

  • Single-Use Ureterorenoscope (Scivita Medical Technology Co., Ltd.)

    Device

    Participants randomized to this arm will undergo retrograde intrarenal surgery (RIRS) for renal stone management using the single-use digital flexible ureterorenoscope manufactured by Scivita Medical Technology Co., Ltd.

Treatment groups

180 Participants
are divided into 3 treatment groups
Group A: LithoVue™ (Boston Scientific Corporation)Active comparator 1 intervention
Group B: WiScope® (OTU Medical Inc. (Silicon Valley, USA))Active comparator 1 intervention
Group C: Single-Use Ureterorenoscope (Scivita Medical Technology Co., Ltd.)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Cost-effectiveness of single-use flexible ureteroscopes

Comparison of total procedural cost and stone-free rate among three single-use flexible ureteroscopes used in retrograde intrarenal surgery (RIRS).

Time frame
4 weeks postoperatively

Secondary outcomes

1

Operative Time and Postoperative Complications

Incidence of postoperative complications within the postoperative period.

Time frame
up to 4 weeks postoperatively

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ain Shams University

Lead sponsor

Source ClinicalTrials.gov
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