Efficacy of Neorenal Forte for the Complete Elimination of Residual Fragments (NCT06651294) | Clinical Trial Compass
RecruitingNot Applicable
Efficacy of Neorenal Forte for the Complete Elimination of Residual Fragments
Bulgaria120 participantsStarted 2025-04-01
Plain-language summary
The purpose of this study is to evaluate the efficacy of a specialized formula of phytotherapeutic extracts (Neorenal Forte) aiding the complete elimination of residual fragments after fURS in adults.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Male or female 18 to 65 years of age.
. The subject has signed informed consent approved by an Ethics Committee and agrees to the on-site study visits.
. A stone confirmed by NCCT of kidney, ureter and urinary bladder for assessment of size, number, location and stone density, within 90 days of fURS.
. Single or multiple kidney stones with total size of 10x10x10 mm to 15x10x10 mm.
. Stone density 1001 - 1400 Hounsfield units (HU).
. Subjects post fURS for laser lithotripsy of kidney stone.
. Residual fragments \< 4 mm after fURS confirmed by ultrasound on first postoperative day.
. Subjects post one fURS.
Exclusion criteria
. Subjects with anatomical anomalies revealed by ultrasound - stenosis of the pyelo-ureteral junction, horseshoe kidney, kidney malrotation, calyceal diverticulum, and others.
. Ureteral stenosis.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of subjects without residual fragments or with fragments ≤ 2mm in diameter.
Timeframe: 90 days + 5 days after endourological treatment.
. Any conditional or absolute contraindications for fURS.
. Combined ipsilateral stone in the ureter or contralateral stone in the upper urinary canal or a stone in the lower urinary canal, requiring simultaneous surgery.
. Subjects with positive urine culture, until resolution.