- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03795532
Ultraslow SWL Versus Slow SWL for Renal Stones With High Attenuation Value (ESWL)
January 20, 2019 updated by: Mohammed Said ElSheemy, Cairo University
Ultraslow Full-power SWL Versus Slow SWL in Renal Stones With High Attenuation Value
Ultraslow full-power SWL versus slow power-ramping SWL in Renal stones with high attenuation value
Study Overview
Detailed Description
To evaluate the efficacy of ultraslow rate of SWL versus slow rate, power ramping SWL for renal stones
Study Type
Interventional
Enrollment (Anticipated)
124
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 Contact
- Name: Mohammed S ElSheemy, Ass. Prof.
- Phone Number: 01006117755
- Email: mohammedshemy@yahoo.com
Study Contact Backup
- Name: Ahmad Aref Al-Dessoukey, Ass. Prof.
Study Locations
-
-
Outside U.S./Canada
-
Banī Suwayf, Outside U.S./Canada, Egypt
- Recruiting
- Beni-Suef Hospitals
-
Contact:
- A AlDessoukey, Ass. Prof.
-
Principal Investigator:
- Mohammed S ElSheemy, A Professor
-
-
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
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
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: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Slow power-ramping SWL
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.
|
Shock wave lithotripsy
Other Names:
|
Active Comparator: Ultraslow shock wave lithotripsy (SWL)
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).
|
Shock wave lithotripsy
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
stone free rate
Time Frame: 3 months following last session of SWL
|
Complete clearance of stones in addition to clinically insignificant residual fragments
|
3 months following last session of SWL
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Complications rate
Time Frame: 3 months following last session of SWL
|
Comparison of rate of complications in both groups
|
3 months following last session of SWL
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Ahmad Aref Al-Dessoukey, Beni-Suef University
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)
January 11, 2019
Primary Completion (Anticipated)
May 1, 2019
Study Completion (Anticipated)
June 1, 2019
Study Registration Dates
First Submitted
January 4, 2019
First Submitted That Met QC Criteria
January 4, 2019
First Posted (Actual)
January 7, 2019
Study Record Updates
Last Update Posted (Actual)
January 23, 2019
Last Update Submitted That Met QC Criteria
January 20, 2019
Last Verified
January 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16224
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
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.
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