Renal Stones Clinical Trial
— SWLOfficial title:
Ultraslow Full-power SWL Versus Slow Power-ramping SWL in Stones With High Attenuation Value
| NCT number | NCT03763539 |
| Other study ID # | 5124 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | September 2015 |
| Est. completion date | May 2018 |
| Verified date | December 2018 |
| Source | Cairo University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Ultraslow full-power SWL versus slow power-ramping SWL in stones with high attenuation value
| Status | Completed |
| Enrollment | 196 |
| Est. completion date | May 2018 |
| Est. primary completion date | May 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - Abnormal renal anatomy - renal insufficiency - solitary kidney - coagulopathies - uncontrolled hypertension - renal artery or aortic aneurysm - 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 |
| Country | Name | City | State |
|---|---|---|---|
| Egypt | Beni-Suef Hospitals | Bani Suwayf | Outside U.S./Canada |
| Lead Sponsor | Collaborator |
|---|---|
| Cairo University |
Egypt,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | stone free rate | Complete clearance of stones in addition to clinically insignificant residual fragments | 3 months following last session of SWL | |
| Secondary | Complications | Comparison of complications in both groups | 1 year following last session of SWL |
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