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NCT05077007 Clinical Trial

Evaluation of Renal Damage After PCNL and ESWL Using Novel RNA Based Biomarkers

Acute Kidney Injury Clinical Trial

Official title:
Evaluation of Renal Damage After PCNL and ESWL Using Novel RNA Based Biomarkers

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05077007
Other study ID # FMASU R 77/ 2021
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 1, 2021
Est. completion date November 1, 2022

Study information
Verified date April 2021
Source Ain Shams University
Contact waleed Mousa, MD
Phone +201067628771
Email waleedmousa2@yahoo.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The study evaluate the damage effect of ESWL and PCNL on kidney tissue by measuring non-coding lnc-RNA profile in urine before and after ESWL and PCNL procedures

Description:

The study evaluate the damage effect of ESWL and PCNL on kidney tissue by measuring non-coding lnc-RNA profile in urine before and after ESWL and PCNL procedures and assess their usefulness as diagnostic biomarkers for AKI and the relationship between the selected RNA based biomarker panel and clinicopathological changes of patients.

Recruitment information / eligibility
Status Recruiting
Enrollment 75
Est. completion date November 1, 2022
Est. primary completion date August 22, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Inclusion criteria for patients : 1. Patients undergoing treatment for a stone(s) located in the kidney less than 2 cm 2. Radiopaque stone 3. Able and willing to give informed consent Inclusion criteria for Healthy volunteers 1. No history of kidney or stone disease 2. Asymptomatic 3. No indwelling ureteral stent 4. Willing to provide medical history information 5. Able and willing to give informed consent Exclusion Criteria: - Exclusion criteria for patients 1. Active urinary tract infection 2. Bleeding disorder 3. Chronic renal failure (eGFR<30) 4. Ureteral stone

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Percutaneous nephrolithotomy
Endoscopic stone Extraction from the kidney by making a puncture and dilate a tract direct into the kidney through muscle wall and renal parenchyma
• Extracorporeal Shock Wave Lithotripsy
Using Shock waves from outside the body targeted at a kidney stone causing the stone to fragment. The stones are broken into tiny pieces.

Locations
Country Name City State
Egypt Urology Department, Faculty of Medicine, Ain Shams University Cairo

Sponsors (2)
Lead Sponsor Collaborator
Ain Shams University Science,Technology & Innovation Funding Authority

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary Evaluation of renal damage after PCNL and ESWL using novel RNA based Biomarkers Evaluation of kidney injury after procedures PCNL and ESWL by measuring the change of the level of novel non-coding lnc-RNA profile in urine Before the procedure by 2hours and after the procedure by 2 and 24 hours
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