ClinicalTrials.gg
CompletedNCT07904676Updated Oct 29, 2026

Flexible Ureteroscopy With Novel Flexible Ureteral Access Sheath Versus Mini-Percutaneous Nephrolithotomy for Treatment of 2-3cm Lower Calyceal Renal Stones

An interventional study of Flexible Ureteroscopy with Novel Flexible Ureteral Access Sheath and Mini-Percutaneous Nephrolithotomy in Renal Stone Disease, Renal Stones and Flexible Ureteroscopy, sponsored by Ain Shams University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-29.

Sponsored by Ain Shams University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 2 months after the study started (first participant enrolled Aug 2024, registered Oct 2026).
Updated Oct 29, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

The aim of the study is to compare the efficacy, safety, and patient outcomes of flexible ureteroscopy with a novel flexible ureteral access sheath and mini-percutaneous nephrolithotomy in the treatment of 2-3 cm lower calyceal renal stones.

02

Conditions studied

  • Renal Stone Disease
  • Renal Stones
  • Flexible Ureteroscopy
  • Mini Percutaneous Nephrolithotomy

Browse trials for

03

In context

Nephrolithiasis

324 studies on the registry are indexed under Nephrolithiasis; 90 are open to participants now.

This study's enrollment of 60 is below the median of 92 across 257 interventional studies indexed under Nephrolithiasis.

Browse Nephrolithiasis studies →

Lead sponsor

Ain Shams University is the lead sponsor of 1,950 studies on the registry; 429 are open to participants now.

Of its 35 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 to 65 Years
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

  • Adults aged 18-65 years
  • Lower Calyceal renal stones measuring 2-3 cm in diameter confirmed by CT scan
  • Candidates suitable for either flexible ureteroscopy with flexible ureteral access sheath or mini-percutaneous nephrolithotomy based on stone characteristics and patient anatomy.

Exclusion criteria

Exclusion Criteria:

  • Severe coagulopathy or bleeding disorders
  • Active urinary tract infection
  • Pregnancy
  • Significant renal anatomical abnormalities complicating access
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
60 participants (actual)

Study arms

  • Active comparator
    Flexible Ureteroscopy with Novel Flexible Ureteral Access Sheath

    Procedure: Flexible Ureteroscopy with Novel Flexible Ureteral Access Sheath

  • Active comparator
    Mini-Percutaneous Nephrolithotomy

    Procedure: Mini-Percutaneous Nephrolithotomy

Interventions

  • ProcedureFlexible Ureteroscopy with Novel Flexible Ureteral Access Sheath

    A novel flexible ureteral access sheath is placed through the ureter. Flexible ureteroscope is advanced through the sheath to the kidney. Holmium laser lithotripsy is used to fragment and remove the stone. Postoperative ureteral stent may be placed if required.

  • ProcedureMini-Percutaneous Nephrolithotomy

    Percutaneous access to the kidney is obtained under fluoroscopic guidance. Tract dilation is performed, and a mini-nephroscope is introduced through 20 Fr access sheath. Stone is fragmented and removed using pneumatic or ultrasonic lithotripsy. Postoperative nephrostomy tube or stent may be placed as per surgeon's judgment.

06

What researchers measure

Primary outcomes

  1. Stone-free rate

    It is defined as no residual stone fragments larger than 3 mm confirmed by imaging.

    Time frame: two weeks

07

Study locations

1 site
  • Ain Shams University
    Cairo, Cairo Governorate 11517, Egypt
08

References and documents

Individual participant data

Plan to share: Yes

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
Oct 29, 2026
Show all 1 update
  1. Oct 29, 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
NCT07904676
Responsible party
Sponsor
First posted
Oct 29, 2026
Start date
Aug 1, 2024
Primary completion
Aug 1, 2026
Completion
Sep 25, 2026
Last update
Oct 29, 2026

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 completed, as verified in Sep 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