Renal StonesNCT02658942
Flexible Ureteroscopy Versus ESWL in the Management of Lower Calyceal Stones
A study testing Ureteroscopy and Shockwave lithotripsy in people with Renal Stones, run by Cairo University at 1 site in Egypt.
Trial summary
to assess safety, efficacy of Flexible ureteroscopy (FURS) holmium:YAG laser lithotripsy (LL) compared to extracorporeal shockwave lithotripsy (ESWL) in management of lower calyceal stones (LC) stones. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Renal Stones
- What is being tested?
- Ureteroscopy and Shockwave lithotripsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- May 2010to May 2015
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- unilateral
- radiopaque stone(s)
- < 2 cm
- located in the lower calyx.
Who cannot join
- Bleeding tendency
- distal obstruction
- Anomalies of the urinary tract
- Solitary kidney
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Flexible Ureteroscopy Versus ESWL in the Management of Lower Calyceal Stones: A Prospective Randomized Study
to assess safety, efficacy of Flexible ureteroscopy (FURS) holmium:YAG laser lithotripsy (LL) compared to extracorporeal shockwave lithotripsy (ESWL) in management of lower calyceal stones (LC) stones.
Read the detailed description
to assess stone free rate, number of sessions and complications of flexible ureteroscopy holmium:YAG laser lithotripsy compared to extracorporeal shockwave lithotripsy in the management of lower calyceal stones less than 2 cm in size.
- Conditions
- Renal Stones
- Being tested
- Ureteroscopy, Shockwave lithotripsy
- Keywords
- renal stones, lower calyx, Ureteroscopy, Shockwave lithotripsy, Holmium laser, Adult, Kidney
- Medical subject headings
- Nephrolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UreteroscopyProcedure or surgery
Also called Flexible Ureteroscopy
In Group A patients, Karl Storz Flex-X 7.5, FURS with a 365 µm laser fiber.
Shockwave lithotripsyProcedure or surgery
Also called ESWL
In Group B patients, a Siemens Lithostar Lithotriptor
| Study group | Role | What they receive |
|---|---|---|
| Ureteroscopy | Active comparator | Intervention: Flexible ureteroscopy for removal of lower calyceal stones using holmium:YAG laser lithotripsy Receives: Procedure: Ureteroscopy |
| Shockwave lithotripsy | Active comparator | Intervention: Shockwave lithotripsy for lithotripsy of lower calyceal stones using Siemens Lithostar Lithotriptor Receives: Procedure: Shockwave lithotripsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stone free rate
no stone fragments or having fragments <3mm
Measured: 3 months
Secondary outcomes (1)
Complications
Bleeding Infection Pain obstruction renal or ureteric injury UTI Fever
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2016 (estimated)
- Study startMay 2010
- Primary completionMay 2012
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal StonesStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mohammed said elsheemy, Cairo University
- Investigators
- Mohammed S ElSheemy, M.D, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02658942
- Sponsor's protocol ID
- 62120
- Status last verified
- Jan 2016
- First submitted
- 14 Jan 2016
- Last updated
- 20 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Flexible Ureteroscopy Versus ESWL in the Management of Lower Calyceal Stones: A Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT02658942
- Acronym / sponsor ID
- 62120
- Conditions
- Renal Stones
- Keywords
- renal stones, lower calyx, Ureteroscopy, Shockwave lithotripsy, Holmium laser, Adult, Kidney
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- May 2012 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 20 Jan 2016 (estimated)
- 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.
to assess safety, efficacy of Flexible ureteroscopy (FURS) holmium:YAG laser lithotripsy (LL) compared to extracorporeal shockwave lithotripsy (ESWL) in management of lower calyceal stones (LC) stones.
Detailed description
to assess stone free rate, number of sessions and complications of flexible ureteroscopy holmium:YAG laser lithotripsy compared to extracorporeal shockwave lithotripsy in the management of lower calyceal stones less than 2 cm in size.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ureteroscopy | Active comparator | Procedure: UreteroscopyIntervention: Flexible ureteroscopy for removal of lower calyceal stones using holmium:YAG laser lithotripsy |
| Shockwave lithotripsy | Active comparator | Procedure: Shockwave lithotripsyIntervention: Shockwave lithotripsy for lithotripsy of lower calyceal stones using Siemens Lithostar Lithotriptor |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- unilateral
- radiopaque stone(s)
- < 2 cm
- located in the lower calyx.
Key exclusion criteria (4 listed)
- Bleeding tendency
- distal obstruction
- Anomalies of the urinary tract
- Solitary kidney
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 |
|---|---|---|
| UreteroscopyAlso: Flexible UreteroscopyIn Group A patients, Karl Storz Flex-X 7.5, FURS with a 365 µm laser fiber. | Procedure or surgery | Ureteroscopy |
| Shockwave lithotripsyAlso: ESWLIn Group B patients, a Siemens Lithostar Lithotriptor | Procedure or surgery | Shockwave lithotripsy |
Primary outcome
Stone free rate
Time frame: 3 months
no stone fragments or having fragments <3mm
1 secondary outcome
Complications
Time frame: 3 years
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 20 Jan 2016.
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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.
Mohammed S ElSheemy, M.D principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ureteroscopy and Shockwave lithotripsy in people with Renal Stones, run by Cairo University at 1 site in Egypt.
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 4 inclusion and 4 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 20 Jan 2016. 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: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Jan 2016.