Evaluation of Renal Damage After PCNL and ESWL Using Novel RNA Based Biomarkers
1 other identifier
interventional
75
1 country
1
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2021
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2021
CompletedFirst Submitted
Initial submission to the registry
August 31, 2021
CompletedFirst Posted
Study publicly available on registry
October 13, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 22, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2022
CompletedFebruary 22, 2022
April 1, 2021
1.6 years
August 31, 2021
February 18, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (3)
Percutaneous nephrolithotomy
ACTIVE COMPARATORpatients suffering of pelvic renal stones underwent Percutaneous nephrolithotomy
Extracorporeal Shock Wave Lithotripsy
ACTIVE COMPARATORpatients suffering of pelvic renal stones underwent Extracorporeal Shock Wave Lithotripsy
control group
NO INTERVENTIONHealthy volunteers with negative history of renal stones or renal impairment to measure the level of urinary markers in their urine samples
Interventions
Endoscopic stone Extraction from the kidney by making a puncture and dilate a tract direct into the kidney through muscle wall and renal parenchyma
Using Shock waves from outside the body targeted at a kidney stone causing the stone to fragment. The stones are broken into tiny pieces.
Eligibility Criteria
You may qualify if:
- Patients undergoing treatment for a stone(s) located in the kidney less than 2 cm
- Radiopaque stone
- Able and willing to give informed consent
- No history of kidney or stone disease
- Asymptomatic
- No indwelling ureteral stent
- Willing to provide medical history information
- Able and willing to give informed consent
You may not qualify if:
- Active urinary tract infection
- Bleeding disorder
- Chronic renal failure (eGFR\<30)
- Ureteral stone
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Urology Department, Faculty of Medicine, Ain Shams University
Cairo, 11884, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
waleed Mousa
Urology Department, Ain Shams University, Abassia, Cairo
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 31, 2021
First Posted
October 13, 2021
Study Start
January 1, 2021
Primary Completion
August 22, 2022
Study Completion
November 1, 2022
Last Updated
February 22, 2022
Record last verified: 2021-04