NCT06651294 Efficacy of Neorenal Forte for the Complete Elimination of Residual Fragments
| NCT ID | NCT06651294 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Neopharm Bulgaria Ltd. |
| Condition | Urolithiasis |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2025-04-01 |
| Primary Completion | 2026-10-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 120 participants in total. It began in 2025-04-01 with a primary completion date of 2026-10-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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.
Contact & Investigator
Marin Georgiev, Prof, PhD
PRINCIPAL INVESTIGATOR
UMHAT "Alexandrovska", Head of Department of Urology, Sofia Medical University
Frequently Asked Questions
Who can join the NCT06651294 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Urolithiasis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06651294 currently recruiting?
Yes, NCT06651294 is actively recruiting participants. Contact the research team at m.futekova@neopharm.bg for enrollment information.
Where is the NCT06651294 trial being conducted?
This trial is being conducted at Burgas, Bulgaria, Pleven, Bulgaria, Pleven, Bulgaria, Plovdiv, Bulgaria and 5 additional locations.
Who is sponsoring the NCT06651294 clinical trial?
NCT06651294 is sponsored by Neopharm Bulgaria Ltd.. The principal investigator is Marin Georgiev, Prof, PhD at UMHAT "Alexandrovska", Head of Department of Urology, Sofia Medical University. The trial plans to enroll 120 participants.