NCT07360353

Brief Summary

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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
4mo left

Started Jan 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress47%
Jan 2026Sep 2026

First Submitted

Initial submission to the registry

January 2, 2026

Completed
20 days until next milestone

First Posted

Study publicly available on registry

January 22, 2026

Completed
3 days until next milestone

Study Start

First participant enrolled

January 25, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

January 27, 2026

Status Verified

January 1, 2026

Enrollment Period

6 months

First QC Date

January 2, 2026

Last Update Submit

January 25, 2026

Conditions

NephrolithiasisRenal Calculi

Keywords

Flexible ureteroscopySingle-use flexible ureteroscopeRenal stones

Outcome Measures

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).

    4 weeks postoperatively

Secondary Outcomes (1)

  • Operative Time and Postoperative Complications

    up to 4 weeks postoperatively

Study Arms (3)

LithoVue™ (Boston Scientific Corporation)

ACTIVE COMPARATOR

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

Device: LithoVue™ (Boston Scientific Corporation)

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

ACTIVE COMPARATOR

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

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

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

ACTIVE COMPARATOR

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.

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

Interventions

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.

LithoVue™ (Boston Scientific Corporation)
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.

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

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

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients aged 18 to 60 years.
  • Presence of renal stones measuring less than 20 millimeters (mm).

You may not qualify if:

  • Renal stones larger than 20 millimeters (mm).
  • Uncontrolled bleeding disorders or coagulopathies.
  • Active urinary tract infection.
  • Renal failure.
  • Uncontrolled diabetes mellitus, hypertension, or hepatic dysfunction.
  • Pregnancy.
  • Abnormal urinary tract anatomy or known ureteric stricture.
  • History of previous open ureteric surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University hospital

Cairo, 11566, Egypt

RECRUITING

MeSH Terms

Conditions

Kidney CalculiNephrolithiasis

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrolithiasisUrinary CalculiMale Urogenital DiseasesCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Hesham E Khayrallah, Resident

    Ain Shams University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hesham E Khayrallah, Resident

CONTACT

+201016704043heshamkhayrallah111@gmail.com

Ashraf M Satour, Lecturer

CONTACT

+201050505463

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 2, 2026

First Posted

January 22, 2026

Study Start

January 25, 2026

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

January 27, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)