ClinicalTrials.gg
Not yet recruitingNCT07921264Updated Nov 6, 2026

Optimal Intrarenal Pressure During Flexible Ureteroscopy

An interventional study of FURS with manual irrigation and FURS with automated irrigation (20 mmHg) in Renal Stone Disease, sponsored by Tanta University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-06.

Sponsored by Tanta University · Not applicable, Interventional, and Treatment

Updated Nov 6, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
300
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The aim of this work is to determine the effect of different automated intrarenal pressure targets during retrograde intrarenal surgery (RIRS) on intrarenal pressure exposure and to identify the pressure target that provides the optimal balance between pressure control, surgical efficiency, and patient safety.

This study will compare manual hand-operated irrigation versus automated irrigation with intrarenal pressure targets of 20, 30 and 40 mmHg. The primary endpoint is the time-weighted IRP, and the key secondary endpoint is the postoperative complications.

02

Conditions studied

  • Renal Stone Disease
03

In context

Lead sponsor

Tanta University is the lead sponsor of 1,010 studies on the registry; 321 are open to participants now.

Of its 15 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age ≥18 years
  • Renal stones 20-30 mm
  • Indicated for F-URS
  • Pre-stenting

Exclusion criteria

Exclusion Criteria:

  • Renal stones less than 20 mm
  • Pregnancy
  • Coagulopathy
  • Active UTI
  • Ureteral stricture
  • Solitary kidney (unless intentionally studying this subgroup)
  • Previous urinary diversion
  • Congenital anomalies preventing FURS
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
300 participants (estimated)

Study arms

  • Active comparator
    FURS with manual hand-operated irrigation

    Procedure: FURS with manual irrigation

  • Experimental
    FURS with automated IRP target of 20 mmHg

    Procedure: FURS with automated irrigation (20 mmHg)

  • Experimental
    FURS with automated IRP target of 30 mmHg

    Procedure: FURS with automated irrigation (30 mmHg)

  • Experimental
    FURS with automated IRP target of 40 mmHg

    Procedure: FURS with automated irrigation (40 mmHg)

Interventions

  • ProcedureFURS with manual irrigation

    FURS with manual hand-operated irrigation

  • ProcedureFURS with automated irrigation (20 mmHg)

    FURS with automated Intrarenal pressure target of 20 mmHg

  • ProcedureFURS with automated irrigation (30 mmHg)

    FURS with automated Intrarenal pressure target of 30 mmHg

  • ProcedureFURS with automated irrigation (40 mmHg)

    FURS with automated Intrarenal pressure target of 40 mmHg

06

What researchers measure

Primary outcomes

  1. Time-weighted mean IRP

    The average pressure inside the renal collecting system throughout a procedure, accounting for how long each pressure level persists

    Time frame: Periprocedural

Secondary outcomes

  1. Postoperative infectious complications

    Postoperative fever, SIRS or sepsis

    Time frame: Up to 4 weeks postoperatively

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Nov 6, 2026
Show all 1 update
  1. Nov 6, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07921264
Lead sponsor
Tanta University
Responsible party
Mahmoud Elrefaey (Principal Investigator, Tanta University) — Principal investigator
First posted
Nov 6, 2026
Start date
Nov 1, 2026 (estimated)
Primary completion
Sep 30, 2028 (estimated)
Completion
Oct 31, 2028 (estimated)
Last update
Nov 6, 2026

Study contacts

Mahmoud Elrefaey
Contact
mahmoud.elrefaey@med.tanta.edu.eg
+201064831315

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion