Efficacy of Neorenal Forte for the Complete Elimination of Residual Fragments

Launched by NEOPHARM BULGARIA LTD. · Oct 18, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a product called Neorenal Forte, which is made from natural plant extracts, to see if it helps completely remove leftover kidney stone fragments after a procedure called flexible ureterorenoscopy (fURS). This procedure is used to break up and remove kidney stones, and the trial aims to determine if Neorenal Forte can help ensure that all small fragments are eliminated afterward.

To participate in this study, you need to be between 18 and 65 years old and have had a recent kidney stone confirmed by a scan. You should also have had fURS to treat the stone and have some small leftover fragments that are less than 4 mm. You must be healthy enough to follow the study's schedule and use a smartphone. If you meet these requirements, you may be eligible to join. Participants will visit the study site regularly and will receive the Neorenal Forte treatment to see how well it works in helping to clear any remaining stone pieces.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Male or female 18 to 65 years of age.
• • 2. The subject has signed informed consent approved by an Ethics Committee and agrees to the on-site study visits.
• • 3. 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.
• • 4. Single or multiple kidney stones with total size of 10x10 mm to 15x10 mm.
• • 5. Stone density 1001 - 1400 Hounsfield units (HU).
• • 6. Subjects post fURS for laser lithotripsy of kidney stone.
• • 7. Residual fragments \< 4 mm after fURS confirmed by ultrasound on first postoperative day.
• • 8. Subjects post one fURS.
• • 9. fURS uncomplicated by perforation of ureter, mucosal exfoliation, damage to kidney or urinary bladder, serious bleeding or other complications.
• • 10. No recent ureterorenoscopy within the last 6 months.
• • 11. Body mass index 17.0 - 29.99 kg/m2 118
• • 12. In Investigator's opinion, the subject can comply with the visit schedule and the treatment regimen and is capable of completing the study.
• • 13. The subject has a smartphone and is capable of using it.
• Exclusion Criteria:
• • 1. Subjects with anatomical anomalies revealed by ultrasound - stenosis of the pyelo-ureteral junction, horseshoe kidney, kidney malrotation, calyceal diverticulum, and others.
• • 2. Ureteral stenosis.
• • 3. History of ipsilateral renal surgery.
• • 4. Hydronephrosis.
• • 5. Permanent JJ stent.
• • 6. Any conditional or absolute contraindications for fURS.
• • 7. 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.
• • 8. Subjects with positive urine culture, until resolution.
• • 9. History of endourological intervention (e.g. nephrostoma, ureteral catheter) before fURS.
• • 10. Stone density \<1000 and \>1401 HU;
• • 11. Uncontrolled diabetes mellitus (HbA1c \>9%).
• • 12. Renal insufficiency.
• • 13. Subjects with arterial hypertension.
• • 14. Subjects with prostate adenoma.
• • 15. Allergy or hypersensitivity to any of the ingredients of the investigational product.
• • 16. BMI ≥ 30 kg/m2.
• • 17. Women who are pregnant or lactating; women who plan on getting pregnant during the study.
• • 18. Alcohol or drug abuse in the last year.
• • 19. Unstable medical conditions, as determined by the Investigator.
• • 20. Inability to comply with the study protocol.
• • 21. Subjects who cannot understand or not capable of completing the study documents.
• • 22. Inability to give informed consent.