Renal StonesSWLNCT03763539
Ultraslow Full-power SWL Versus Slow Power-ramping SWL in Stones With High Attenuation Value
A study testing SWL in people with Renal Stones, run by Cairo University at 1 site in Egypt.
Trial summary
Ultraslow full-power SWL versus slow power-ramping SWL in stones with high attenuation value Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Stones
- What is being tested?
- SWL
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 196 participants
- Where
- 1 siteEgypt
- Study dates
- Sep 2015to May 2018
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- single renal stone less than or equal to 3 cm (2 cm for lower calyceal stones)
- radio-opaque stone
- high attenuation value (≥ 1000 HU) stone
Who cannot join
- Abnormal renal anatomy
- renal insufficiency
- solitary kidney
- coagulopathies
- uncontrolled hypertension
- renal artery or aortic aneurysm
Show all 11Show fewer
- active urinary tract infection
- pregnancy
- severe skeletal malformations (spinal deformity) precluding proper stone localization
- skin to stone distance (SSD) > 11 cm
- BMI > 30 Kgm/m2
Trial locations and contacts
1 site in 1 country.
About this study
Ultraslow full-power SWL versus slow power-ramping SWL in stones with high attenuation value
Read the detailed description
To evaluate the efficacy of ultraslow rate of SWL versus slow rate, power ramping SWL.
- Conditions
- Renal Stones
- Being tested
- SWL
- Keywords
- renal stones, SWL, High density stones, Ultraslow SWL, Slow SWL, Ramping, Pause
- Medical subject headings
- Nephrolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SWLProcedure or surgery
Also called ESWL
Shock wave lithotripsy
| Study group | Role | What they receive |
|---|---|---|
| Ultraslow shock wave lithotripsy (SWL) | Active comparator | SWL at ultraslow rate of 30 SW/min. Power ramping at the first 100 SW from 6 to 18 kv followed by safety pause for two minutes then power ramping from 18 to 22kv during the second 100 SW followed by safety pause for another two minutes.
The rest of the session at 22kv (full power). Receives: Procedure: SWL |
| Slow power-ramping SWL | Active comparator | SWL at a slow rate of 60 SW/min. Power ramping from 6 - 10 kv during the first 500 SW then from 11 - 14 kv during the second 500 SW then from 15 - 18 kv during the following 500 SW then from 19 - 22 kv during the remaining 1000 - 1500 SW. Receives: Procedure: SWL |
What is being measured
The primary outcome is the main question the study is designed to answer.
stone free rate
Complete clearance of stones in addition to clinically insignificant residual fragments
Measured: 3 months following last session of SWL
Secondary outcomes (1)
Complications
Comparison of complications in both groups
Measured: 1 year following last session of SWL
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2018
- Study startSep 2015
- Primary completionMay 2017
- Study completionMay 2018
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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 196 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
- Ahmad Aref Al-Dessoukey, Ass. Prof., Study director, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03763539
- Sponsor's protocol ID
- 5124
- Acronym
- SWL
- Status last verified
- Dec 2018
- First submitted
- 1 Dec 2018
- Last updated
- 4 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultraslow Full-power SWL Versus Slow Power-ramping SWL in Stones With High Attenuation Value
- ClinicalTrials.gov ID
- NCT03763539
- Acronym / sponsor ID
- SWL / 5124
- Conditions
- Renal Stones
- Keywords
- renal stones, SWL, High density stones, Ultraslow SWL, Slow SWL, Ramping, Pause
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 196 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Sep 2015 (actual)
- Primary completion
- May 2017 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 4 Dec 2018 (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.
Ultraslow full-power SWL versus slow power-ramping SWL in stones with high attenuation value
Detailed description
To evaluate the efficacy of ultraslow rate of SWL versus slow rate, power ramping SWL.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultraslow shock wave lithotripsy (SWL) | Active comparator | Procedure: SWLSWL at ultraslow rate of 30 SW/min. Power ramping at the first 100 SW from 6 to 18 kv followed by safety pause for two minutes then power ramping from 18 to 22kv during the second 100 SW followed by safety pause for another two minutes. The rest of the session at 22kv (full power). |
| Slow power-ramping SWL | Active comparator | Procedure: SWLSWL at a slow rate of 60 SW/min. Power ramping from 6 - 10 kv during the first 500 SW then from 11 - 14 kv during the second 500 SW then from 15 - 18 kv during the following 500 SW then from 19 - 22 kv during the remaining 1000 - 1500 SW. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- single renal stone less than or equal to 3 cm (2 cm for lower calyceal stones)
- radio-opaque stone
- high attenuation value (≥ 1000 HU) stone
Key exclusion criteria (11 listed)
- Abnormal renal anatomy
- renal insufficiency
- solitary kidney
- coagulopathies
- uncontrolled hypertension
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 |
|---|---|---|
| SWLAlso: ESWLShock wave lithotripsy | Procedure or surgery | Slow power-ramping SWL, Ultraslow shock wave lithotripsy (SWL) |
Primary outcome
stone free rate
Time frame: 3 months following last session of SWL
Complete clearance of stones in addition to clinically insignificant residual fragments
1 secondary outcome
Complications
Time frame: 1 year following last session of SWL
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 4 Dec 2018.
- Individual participant dataSharing planned: No
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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.
Ahmad Aref Al-Dessoukey, Ass. Prof. study director
Beni-Suef 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 SWL 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 3 inclusion and 11 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 4 Dec 2018. 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 following last session of SWL). 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 4 Dec 2018.