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Tests treatment safety and results for Urolithiasis
Official title Efficacy of Neorenal Forte for the Complete Elimination of Residual Fragments
ClinicalTrials.gov ID: NCT06651294
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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 10x10 mm to 15x10 mm.
- Stone density 1001 - 1400 Hounsfield units (HU).
You likely can't join if
- people with anatomical anomalies revealed by ultrasound - stenosis of the pyelo-ureteral junction, horseshoe kidney, kidney malrotation, calyceal...
- Ureteral stenosis.
- History of ipsilateral renal surgery.
- Hydronephrosis.
- Permanent JJ stent.
- Any conditional or absolute contraindications for fURS.
See the full eligibility 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 10x10 mm to 15x10 mm.
- Stone density 1001 - 1400 Hounsfield units (HU).
- people post fURS for laser lithotripsy of kidney stone.
- Residual fragments \< 4 mm after fURS confirmed by ultrasound on first postoperative day.
- people post one fURS.
- fURS uncomplicated by perforation of ureter, mucosal exfoliation, damage to kidney or urinary bladder, serious bleeding or other complications.
- No recent ureterorenoscopy within the last 6 months.
- Body mass index 17.0 - 29.99 kg/m2 118
- In Investigator's opinion, the subject can comply with the visit schedule and the treatment regimen and is capable of completing the study.
- The subject has a smartphone and is capable of using it.
- people with anatomical anomalies revealed by ultrasound - stenosis of the pyelo-ureteral junction, horseshoe kidney, kidney malrotation, calyceal diverticulum, and others.
- Ureteral stenosis.
- History of ipsilateral renal surgery.
- Hydronephrosis.
- Permanent JJ stent.
- 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.
- people with positive urine culture, until resolution.
- History of endourological intervention (e.g. nephrostoma, ureteral catheter) before fURS.
- Stone density \ 1401 HU;
- Uncontrolled diabetes mellitus (HbA1c \>9%).
- Renal insufficiency.
- people with arterial hypertension.
- people with prostate adenoma.
- Allergy or hypersensitivity to any of the ingredients of the investigational product.
- BMI ≥ 30 kg/m2.
- Women who are pregnant or lactating; women who plan on getting pregnant during the study.
- Alcohol or drug abuse in the last year.
- Unstable medical conditions, as determined by the Investigator.
- Inability to comply with the study protocol.
- people who cannot understand or not capable of completing the study documents.
- Inability to give informed consent.
The study team makes the final eligibility decision.
Where it's taking place
- Burgas, Bulgaria
- Pleven, Bulgaria
- Plovdiv, Bulgaria
- Sofia, Bulgaria
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Burgas, Bulgaria; Pleven, Bulgaria; Plovdiv, Bulgaria; Sofia, Bulgaria. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.