Renal StonesNCT06120257

Management of Lower Pole Renal Hard Stones ≤2 cm

A study testing lithotripsy using Flexible ureteroscope, extracorporeal shock wave lithotripsy (ESWL) and holmium laser lithotripsy using Karl® Storz MIP set in people with Renal Stones, run by Elsayed Abdelhalim Elsayed at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Renal Stones
What is being tested?: lithotripsy using Flexible ureteroscope, extracorporeal shock wave lithotripsy (ESWL) and holmium laser lithotripsy using Karl® Storz MIP set
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 414 participants
Where: 1 siteEgypt
Study dates: 1 Mar 2022to 1 Sep 2022
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

• multiple renal stones
stone size > 2 cm
age group < 18
solitary kidney
Patients with BMI > 40 kg/m2
bleeding disorders

Show all 9Show fewer

anatomical renal abnormalities
Obstruction distal to the stone.
Musculoskeletal deformities

Trial locations and contacts

1 site in 1 country.

Egypt1 site

Kafrelsheikh University hospital
Kafr ash Shaykh

Other trials in Egypt

About this study

Official title: Flexible Ureteroscopy , Extracorporeal Shock Wave Lithotripsy and Mini Percutaneous Nephrolithotomy for Management of Lower Pole Renal Hard Stones ≤2 cm: Prospective Comparative Study

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.

Conditions: Renal Stones
Being tested: lithotripsy using Flexible ureteroscope, extracorporeal shock wave lithotripsy (ESWL), holmium laser lithotripsy using Karl® Storz MIP set
Keywords: Hard stones
Medical subject headings: Nephrolithiasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

lithotripsy using Flexible ureteroscopeProcedure or surgery
using Flexible ureteroscope and holmium laser lithotripsy to get high stone clearance rate
extracorporeal shock wave lithotripsy (ESWL)Procedure or surgery
using extracorporeal shock wave lithotripsy (ESWL) to get high stone clearance rate
holmium laser lithotripsy using Karl® Storz MIP setProcedure or surgery
using holmium laser lithotripsy using Karl® Storz MIP set to get high stone clearance rate

Study groups in NCT06120257
Study group	Role	What they receive
Group A :Flexible ureteroscope group	Active comparator	Flexible ureteroscope (F-URS) group underwent holmium laser lithotripsy using flexible ureteroscopy (Boston® scientific (lithovue) Receives: Procedure: lithotripsy using Flexible ureteroscope
Group B : extracorporeal shock wave lithotripsy (ESWL) group	Active comparator	extracorporeal shock wave lithotripsy (ESWL) group underwent electromagnetic extracorporeal shock wave lithotripsy (STORZ® MEDICAL Modulith SLX-F2 FD21, Germany) Receives: Procedure: extracorporeal shock wave lithotripsy (ESWL)
Group C : Mini perc group	Active comparator	Mini perc group underwent holmium laser lithotripsy using Karl® Storz MIP set. Receives: Procedure: holmium laser lithotripsy using Karl® Storz MIP set

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: after two weeks from primary procedure

Secondary outcomes (4)

assess operative time.
assess operative time.in minutes
Measured: during the procedure
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.
Measured: immediately after the surgery
Radiation time
Time of patient exposure for radiation in minutes
Measured: during the procedure
Post operative complication
Complication may occur post operative complication like fever, sever pain
Measured: Up to 48 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Mar 20221 Sep 2022

First posted7 Nov 2023
Study start1 Mar 2022
Primary completion1 Sep 2022
Study completion1 Sep 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Renal StonesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 414 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06120257
Sponsor's protocol ID: KFSIRB200-69
Status last verified: Dec 2023
First submitted: 22 Oct 2023
Last updated: 18 Dec 2023
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

Zeinelabden KM, Abdelhalim E, Galal M, Abdelbaky T, Nabeeh H. Flexible ureteroscopy, extracorporeal shock wave lithotripsy and mini percutaneous nephrolithotomy for management of lower pole renal hard stones </= 2 cm: a prospective randomized study. BMC Urol. 2024 Dec 30;24(1):288. doi: 10.1186/s12894-024-01644-z.
PubMed 39736616

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Stone Clearance With Aspiration vs Other Technologies: a Real-world Evidence Study
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Intertransverse Process Block Versus Erector Spinae Plane Block for Postoperative Analgesia After Percutaneous Nephrolithotomy
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Comparison of Smart Pressure-Controlled Flexible Ureteroscopy and Flexible Suction Ureteral Access Sheath-Assisted Flexible Ureteroscopy for 2-3 cm Renal Stones
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All Renal Stones trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Flexible Ureteroscopy , Extracorporeal Shock Wave Lithotripsy and Mini Percutaneous Nephrolithotomy for Management of Lower Pole Renal Hard Stones ≤2 cm: Prospective Comparative Study
ClinicalTrials.gov ID: NCT06120257
Acronym / sponsor ID: KFSIRB200-69
Conditions: Renal Stones
Keywords: Hard stones
Study type: Interventional
Recruitment status: Completed
Enrolment: 414 participants (actual)
Lead sponsor: Elsayed Abdelhalim ElsayedUniversity, hospital or other
Study start: 1 Mar 2022 (actual)
Primary completion: 1 Sep 2022 (actual)
Study completion: 1 Sep 2022 (actual)
First posted: 7 Nov 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Group A :Flexible ureteroscope group	Active comparator	Procedure: lithotripsy using Flexible ureteroscopeFlexible ureteroscope (F-URS) group underwent holmium laser lithotripsy using flexible ureteroscopy (Boston® scientific (lithovue)
Group B : extracorporeal shock wave lithotripsy (ESWL) group	Active comparator	Procedure: extracorporeal shock wave lithotripsy (ESWL)extracorporeal shock wave lithotripsy (ESWL) group underwent electromagnetic extracorporeal shock wave lithotripsy (STORZ® MEDICAL Modulith SLX-F2 FD21, Germany)
Group C : Mini perc group	Active comparator	Procedure: holmium laser lithotripsy using Karl® Storz MIP setMini perc group underwent holmium laser lithotripsy using Karl® Storz MIP set.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (9 listed)

• multiple renal stones

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
lithotripsy using Flexible ureteroscopeusing Flexible ureteroscope and holmium laser lithotripsy to get high stone clearance rate	Procedure or surgery	Group A :Flexible ureteroscope group
extracorporeal shock wave lithotripsy (ESWL)using extracorporeal shock wave lithotripsy (ESWL) to get high stone clearance rate	Procedure or surgery	Group B : extracorporeal shock wave lithotripsy (ESWL) group
holmium laser lithotripsy using Karl® Storz MIP setusing holmium laser lithotripsy using Karl® Storz MIP set to get high stone clearance rate	Procedure or surgery	Group C : Mini perc group

Primary outcome

stone free rate
Time frame: after 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.

4 secondary outcomes

assess operative time.
Time frame: during the procedure
visual analog scale
Time frame: immediately after the surgery
Radiation time
Time frame: during the procedure
Post operative complication
Time frame: Up to 48 hours

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2023.
Derived from this study: PubMed 39736616Zeinelabden KM, Abdelhalim E, Galal M, Abdelbaky T, Nabeeh H. Flexible ureteroscopy, extracorporeal shock wave lithotripsy and mini percutaneous nephrolithotomy for management of lower pole renal hard stones </= 2 cm: a prospective randomized study. BMC Urol. 2024 Dec 30;24(1):288. doi: 10.1186/s12894-024-01644-z.
Individual participant dataSharing planned: Undecided

Related trials for Renal Stones

Not yet recruiting
Automated Versus Manual Irrigation During Flexible Ureteroscopy
Renal Stone Disease
Not yet recruiting
Optimal Intrarenal Pressure During Flexible Ureteroscopy
Renal Stone Disease
RecruitingObservational study
Stone Clearance With Aspiration vs Other Technologies: a Real-world Evidence Study
Urolithiasis, Stones, Kidney
Not yet recruiting
Intertransverse Process Block Versus Erector Spinae Plane Block for Postoperative Analgesia After Percutaneous Nephrolithotomy
Kidney Stones, Urolithiasis, Hypocitraturia, Pain, Postoperative
Not yet recruiting
Comparison of Smart Pressure-Controlled Flexible Ureteroscopy and Flexible Suction Ureteral Access Sheath-Assisted Flexible Ureteroscopy for 2-3 cm Renal Stones
Kidney Stones

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

stone free rate (time frame: after two weeks from primary procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06120257, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2023.