CClinicalTrials.gg
CompletedNCT06120257Updated Dec 18, 2023

Management of Lower Pole Renal Hard Stones ≤2 cm

An interventional study of lithotripsy using Flexible ureteroscope and extracorporeal shock wave lithotripsy (ESWL) in Renal Stones, sponsored by Elsayed Abdelhalim Elsayed. Completed at 1 site in Egypt. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-12-18.

Sponsored by Elsayed Abdelhalim Elsayed · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 7 months after the study started (first participant enrolled Mar 2022, registered Oct 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
414
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The study has been conducted in Urology department at Kafrelsheikh University Hospital between March 2022 to March 2023. informed consent was taken from eligible patients and were randomized into three groups, Group A :Flexible ureteroscope (F-URS) group underwent holmium laser lithotripsy using flexible ureteroscopy (Boston® scientific (lithovue) while, Group B : extracorporeal shock wave lithotripsy (ESWL) group underwent electromagnetic extracorporeal shock wave lithotripsy (STORZ® MEDICAL Modulith SLX-F2 FD21, Germany) .Group C : Mini perc group underwent holmium laser lithotripsy using Karl® Storz MIP set.

02

Conditions studied

  • Renal Stones

Keywords

  • Hard stones
03

In context

Kidney Calculi

598 studies on the registry are indexed under Kidney Calculi; 163 are open to participants now.

This study's enrollment of 414 is above the median of 90 across 461 interventional studies indexed under Kidney Calculi.

Browse Kidney Calculi studies →

Lead sponsor

Elsayed Abdelhalim Elsayed is the lead sponsor of 2 studies on the registry; none are open to participants now.

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

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Adult patient older than 18 years.
  • single renal stone.
  • medium sized Stone up to 2.0 cm .
  • Do novo
  • Stone in lower calyceal stone
  • Hard stone

Exclusion criteria

Exclusion Criteria:

    • multiple renal stones

      • stone size > 2 cm
      • age group \< 18
      • solitary kidney
      • Patients with BMI > 40 kg/m2
      • bleeding disorders
      • anatomical renal abnormalities
      • Obstruction distal to the stone.
      • Musculoskeletal deformities
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
414 participants (actual)

Study arms

  • Active comparator
    Group A :Flexible ureteroscope group

    Flexible ureteroscope (F-URS) group underwent holmium laser lithotripsy using flexible ureteroscopy (Boston® scientific (lithovue)

    Procedure: lithotripsy using Flexible ureteroscope

  • Active comparator
    Group B : extracorporeal shock wave lithotripsy (ESWL) group

    extracorporeal shock wave lithotripsy (ESWL) group underwent electromagnetic extracorporeal shock wave lithotripsy (STORZ® MEDICAL Modulith SLX-F2 FD21, Germany)

    Procedure: extracorporeal shock wave lithotripsy (ESWL)

  • Active comparator
    Group C : Mini perc group

    Mini perc group underwent holmium laser lithotripsy using Karl® Storz MIP set.

    Procedure: holmium laser lithotripsy using Karl® Storz MIP set

Interventions

  • Procedurelithotripsy using Flexible ureteroscope

    using Flexible ureteroscope and holmium laser lithotripsy to get high stone clearance rate

  • Procedureextracorporeal shock wave lithotripsy (ESWL)

    using extracorporeal shock wave lithotripsy (ESWL) to get high stone clearance rate

  • Procedureholmium laser lithotripsy using Karl® Storz MIP set

    using holmium laser lithotripsy using Karl® Storz MIP set to get high stone clearance rate

06

What researchers measure

Primary outcomes

  1. stone free rate

    no stone residual fragments or asymptomatic insignificant residual fragments less than or equal to 4 mm during patients follow up two weeks.

    Time frame: after two weeks from primary procedure

Secondary outcomes

  1. assess operative time.

    assess operative time.in minutes

    Time frame: during the procedure

  2. visual analog scale

    Patient self dependent to assess degree of own pain, consists of a 10cm line, with two end points representing 0 minimum score('no pain') and 10 maximum score('pain as bad as it could possibly be').higher scores mean a worse outcome.

    Time frame: immediately after the surgery

  3. Radiation time

    Time of patient exposure for radiation in minutes

    Time frame: during the procedure

  4. Post operative complication

    Complication may occur post operative complication like fever, sever pain

    Time frame: Up to 48 hours

07

Study locations

1 site
  • Kafrelsheikh University hospital
    Kafr Ash Shaykh, Egypt
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 18, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06120257
Lead sponsor
Elsayed Abdelhalim Elsayed
Responsible party
Elsayed Abdelhalim Elsayed (Principal Investigator, Kafrelsheikh University) — Sponsor-investigator
First posted
Nov 7, 2023
Start date
Mar 1, 2022
Primary completion
Sep 1, 2022
Completion
Sep 1, 2022
Last update
Dec 18, 2023

Oversight

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 Dec 2023. You cannot join it, but the record below documents what was studied.

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