ClinicalTrials.gg
CompletedNCT06465784Updated Jun 20, 2024

Laser Lithotripsy for Ureteral Stones

A Phase 4 interventional study of Retrograde and Antegrade Ureteroscopic Laser Lithotripsy in Ureteric Stone, sponsored by Mahmoud Helmy El saeed Hussein. Completed at 1 site in Egypt. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-06-20.

Sponsored by Mahmoud Helmy El saeed Hussein · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 2 months after the study started (first participant enrolled Mar 2023, registered May 2024).
Phase
Phase 4
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

Objectives: To present the outcomes of retrograde and antegrade ureteroscopic laser lithotripsy in the treatment of proximal ureteral stones ranging in size from 10 to 20 millimeters in diameter.

Patients and methods: From March 2023 to December 2023, 70 patients were included in this prospective randomized double-arm interventional study. Patients were divided into two groups: Group 1: (35 patients) had semi-rigid retrograde ureteroscopic laser lithotripsy and group 2: (35 patients) had semi-rigid antegrade ureteroscopic laser lithotripsy.

Read the detailed description

The present study was conducted in Al-Azhar University Hospital (Damietta branch), urology department,at the period from March 2023 to December 2023. Seventy patients with symptomatic proximal medium sized ureteric stones were classified in two groups Retrograde Uretroscopic Laser Lithotripsy (group 1) and Antegrade Ureteroscopic Laser Lithotripsy (group 2) .

The preoperative-(patient- and stone-related), intraoperative- and postoperative- related parameters that might influence the perioperative course and short-term clinical outcomes were evaluated.

02

Conditions studied

  • Ureteric Stone

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Keywords

  • laser treatment
  • ureteric stones
  • ureteroscope
  • retrograde
  • antegrade
03

In context

Ureterolithiasis

84 studies on the registry are indexed under Ureterolithiasis; 19 are open to participants now.

This study's enrollment of 70 is below the median of 101 across 66 interventional studies indexed under Ureterolithiasis.

Browse Ureterolithiasis studies →

Lead sponsor

This is the only study on the registry with Mahmoud Helmy El saeed Hussein as lead sponsor.

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

  • Patients with medium-sized proximal ureteral stones (10-20 mm) situated between the ureteropelvic junction and the top edge of the L5 vertebral body; age 18-65 years

Exclusion criteria

Exclusion Criteria:

  • Pregnancy, bleeding disorders, morbid obesity ( > 35), patients with stenosis of the ureter, history of previous surgery on the ipsilateral ureter, patients with a simultaneous kidney stone requiring surgery, and patients with an active urinary tract infection
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
70 participants (actual)

Study arms

  • Active comparator
    Retrograde Ureteroscopic Laser Lithotripsy

    In this arm we used the retrograde ureteroscopic Laser lithotripsy to clear the uretric stones. After the end of the procedure, all patients were followed for stone free rate as the primary outcome

    Procedure: Retrograde and Antegrade Ureteroscopic Laser Lithotripsy

  • Active comparator
    Antegrade Ureteroscopic Laser Lithotripsy

    In this arm we used the antegrade ureteroscopic Laser lithotripsy to clear the uretric stones. After the end of the procedure, all patients were followed for stone free rate as the primary outcome.

    Procedure: Retrograde and Antegrade Ureteroscopic Laser Lithotripsy

Interventions

  • ProcedureRetrograde and Antegrade Ureteroscopic Laser Lithotripsy

    Comparison Between Retrograde and Antegrade Ureteroscopic Laser Lithotripsy for Management of Medium Sized Proximal Ureteral Stones: A Randomized Prospective Study

06

What researchers measure

Primary outcomes

  1. Stone free rate

    number of patients reported complete clearance of stones after intervention

    Time frame: Direct after intervention

07

Study locations

1 site
  • Damietta Faculty of Medicine, Al-Azhar University, Damietta, Egypt.
    Damietta, 34517, Egypt
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Mar 2023 to primary completion in Dec 2023, 9 months.

How these figures are worked out, and which studies are left out of them.

Registered
May 29, 2024
First posted
Jun 20, 2024
StartActual
Mar 1, 2023
Primary completionActual
Dec 31, 2023
CompletionActual
Dec 31, 2023
Last update
Jun 20, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 20, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06465784
Lead sponsor
Mahmoud Helmy El saeed Hussein
Responsible party
Mahmoud Helmy El saeed Hussein (Professor, Al-Azhar University) — Sponsor-investigator
First posted
Jun 20, 2024
Start date
Mar 1, 2023
Primary completion
Dec 31, 2023
Completion
Dec 31, 2023
Last update
Jun 20, 2024

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 Jun 2024. You cannot join it, but the record below documents what was studied.

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