Actively Recruiting
Efficacy of Neorenal Forte for the Complete Elimination of Residual Fragments
Led by Neopharm Bulgaria Ltd. · Updated on 2025-11-28
120
Participants Needed
9
Research Sites
86 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Efficacy of Neorenal Forte for the Complete Elimination of Residual Fragments
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female 18 to 65 years of age.
- Signed informed consent approved by an Ethics Committee and agrees to on-site study visits.
- Kidney, ureter, and bladder stone confirmed by NCCT within 90 days of flexible ureterorenoscopy (fURS).
- Single or multiple kidney stones with total size from 10x10 mm to 15x10 mm.
- Stone density between 1001 and 1400 Hounsfield units (HU).
- Post fURS for laser lithotripsy of kidney stone.
- Residual fragments less than 4 mm confirmed by ultrasound on first postoperative day.
- Only one fURS procedure performed.
- No complications during fURS such as perforation, mucosal exfoliation, kidney or bladder damage, serious bleeding.
- No ureterorenoscopy within the last 6 months.
- Body mass index between 17.0 and 29.99 kg/m2.
- Able to comply with visit schedule and treatment regimen.
- Owns a smartphone and can use it.
You will not qualify if you...
- Anatomical anomalies detected by ultrasound (e.g., stenosis of the pyelo-ureteral junction, horseshoe kidney, kidney malrotation, calyceal diverticulum).
- Ureteral stenosis.
- History of surgery on the same kidney side.
- Hydronephrosis.
- Permanent JJ stent.
- Any contraindications for flexible ureterorenoscopy.
- Combined stones requiring simultaneous surgery in the ureter or urinary canal.
- Positive urine culture until resolved.
- History of endourological intervention before fURS.
- Stone density less than 1000 or greater than 1401 HU.
- Uncontrolled diabetes mellitus (HbA1c above 9%).
- Renal insufficiency.
- Arterial hypertension.
- Prostate adenoma.
- Allergy or hypersensitivity to ingredients of the investigational product.
- Body mass index 30 kg/m2 or higher.
- Women who are pregnant, breastfeeding, or planning pregnancy during the study.
- Alcohol or drug abuse within the past year.
- Unstable medical conditions.
- Unable to comply with study protocol.
- Cannot understand or complete study documents.
- Unable to give informed consent.
AI-Screening
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Trial Site Locations
Total: 9 locations
1
MHAT "Heart and Brain"
Burgas, Bulgaria
Actively Recruiting
2
UMHAT "Dr. Georgi Stranski"
Pleven, Bulgaria, 5800
Actively Recruiting
3
University Hospital for Active Treatment "Saint Marina"
Pleven, Bulgaria, 5800
Actively Recruiting
4
UMHAT "St. George"
Plovdiv, Bulgaria, 4000
Actively Recruiting
5
UMHAT Kaspela
Plovdiv, Bulgaria, 4001
Actively Recruiting
6
UMHAT "Alexandrovska"
Sofia, Bulgaria, 1431
Actively Recruiting
7
Military Medical Academy
Sofia, Bulgaria, 1606
Actively Recruiting
8
UMBALSM "N. I. Pirogov"
Sofia, Bulgaria, 1606
Actively Recruiting
9
UMHAT "Sofiamed"
Sofia, Bulgaria, 1797
Actively Recruiting
Research Team
M
Margarita Futekova
CONTACT
S
Stefan Tunev, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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