- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07445646
Efficacy of Different Modalities on Management of Renal Hard Stones
March 2, 2026 updated by: Elsayed Abdelhalim Elsayed, Kafrelsheikh University
Comparative Outcomes of FURS, ESWL and Mini-PCNL for Non-Lower Pole Hard Renal Stones: A Prospective Randomized Study.
The study has been conducted in Urology department at Kafrelsheikh University Hospital between Feburary 2021 to December 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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
300
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Zagazig, Egypt, 44749
- Elsayed Abdelhalim
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Adult patient older than 18 years.
- single renal stone.
- medium sized Stone up to 2.0 cm .
- Do novo
- Stone in plevicalyceal except lower calyceal stone
- Hard stone
Exclusion Criteria:
- multiple renal stones
- Stone in lower calyceal stone
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Group A :Flexible ureteroscope group
Flexible ureteroscope (F-URS) group underwent holmium laser lithotripsy using flexible ureteroscopy (Boston® scientific (lithovue)
|
using Flexible ureteroscope and holmium laser lithotripsy to get high stone clearance rate
|
|
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)
|
using extracorporeal shock wave lithotripsy (ESWL) to get high stone clearance rate
|
|
Active Comparator: Group C : Mini perc group
Mini perc group underwent holmium laser lithotripsy using Karl® Storz MIP set.
|
using holmium laser lithotripsy using Karl® Storz MIP set to get high stone clearance rate
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
stone free rate
Time Frame: two weeks from primary procedure
|
no stone residual fragments or asymptomatic insignificant residual fragments less than or equal to 4 mm during patients follow up two weeks.
|
two weeks from primary procedure
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Radiation time
Time Frame: during the procedure
|
Time of patient exposure for radiation in minutes
|
during the procedure
|
|
Post operative complication
Time Frame: Up to 48 hours
|
Complication may occur post operative complication like fever, sever pain
|
Up to 48 hours
|
|
ssess operative time
Time Frame: during the procedure
|
assess operative time.in
minutes
|
during the procedure
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2021
Primary Completion (Actual)
December 30, 2023
Study Completion (Actual)
December 30, 2023
Study Registration Dates
First Submitted
February 25, 2026
First Submitted That Met QC Criteria
February 25, 2026
First Posted (Actual)
March 3, 2026
Study Record Updates
Last Update Posted (Actual)
March 4, 2026
Last Update Submitted That Met QC Criteria
March 2, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Male Urogenital Diseases
- Calculi
- Pathological Conditions, Anatomical
- Kidney Diseases
- Urologic Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urinary Calculi
- Nephrolithiasis
- Pathological Conditions, Signs and Symptoms
- Kidney Calculi
- Urolithiasis
- Therapeutics
- Surgical Procedures, Operative
- Ultrasonic Surgical Procedures
- Lithotripsy
Other Study ID Numbers
- Renal Stones
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Urolithiasis
-
Beni-Suef UniversityRecruiting
-
Singapore General HospitalUnknown
-
Kırıkkale UniversityCompletedKidney Calculi Nephrolithiasis Urolithiasis Renal Stone
-
University of Sao Paulo General HospitalCompletedUrolithiasis and Aging | Renal Calcul and Metabolic Diseases | Urolithiasis and OsteoporosisBrazil
-
EULIS Colloborative Research Working GroupUnknownKidney Calculi | Nephrolithiasis | Patient Compliance | Calcium Oxalate Urolithiasis
-
University of Alabama at BirminghamNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); University...RecruitingHealthy | Kidney Calculi | Nephrolithiasis | Urolithiasis | Kidney Stone | Nephrolithiasis, Calcium Oxalate | Oxaluria | Urolithiasis, Calcium Oxalate | Oxalate UrolithiasisUnited States
-
Catalysis SLCompletedKidney Calculi | Kidney Injury | Urolithiasis | Ureteral Calculi | Ureteral Obstruction | Renal Disease | Renal Stone | Ureteral Injury | Renal Injury | Urolithiasis, Calcium Oxalate | Urolithiasis; Lower Urinary TractNicaragua
-
London Health Sciences Centre Research Institute...St. Joseph's Health Care LondonCompletedKidney Calculi | Nephrolithiasis | Kidney Stone | Human | Calcium Oxalate Urolithiasis | Vitamin K 2 | Calcium Oxalate Kidney Stones | Calcium Phosphate UrolithiasisCanada
-
University of Alabama at BirminghamNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); University...RecruitingHealthy | Kidney Calculi | Nephrolithiasis | Urolithiasis | Healthy Volunteer | Kidney Stones | Nephrolithiasis, Calcium Oxalate | Urolithiasis, Calcium Oxalate | Oxalate UrolithiasisUnited States
-
University of Alabama at BirminghamNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); University...RecruitingKidney Calculi | Nephrolithiasis | Urolithiasis | Kidney Stone | Nephrolithiasis, Calcium Oxalate | Oxaluria | Urolithiasis, Calcium Oxalate | Oxalate UrolithiasisUnited States
Clinical Trials on holmium laser lithotripsy using Karl® Storz MIP
-
Elsayed Abdelhalim ElsayedCompleted