BridgeMD
New treatment option for Pediatric Urolithiasis
Official title Intravesical Aminophylline to Facilitate Ureteroscopic Access in Children With Distal Ureteral Stones.
ClinicalTrials.gov ID: NCT07617896
What this study is testing
What is Aminophylline?
Aminophylline is an investigational medicine, being studied as a potential treatment for pediatric urolithiasis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study will evaluate whether intravesical aminophylline can facilitate semi-rigid ureteroscopic access in children with distal ureteral stones when the first gentle attempt to enter the ureter is unsuccessful. Children scheduled for semi-rigid ureteroscopy for distal ureteral stones will first undergo the standard gentle attempt to pass the ureteroscope through the ureteric orifice and intramural ureter.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 2 to 18
You may be able to join if
- Children older than 2 years and younger than 18 years.
- Single unilateral lower/distal ureteral stone confirmed by low-dose non-contrast computed tomography according to local policy.
- Stone size 5 to 15 mm.
- Candidate for definitive treatment by semi-rigid ureteroscopy.
- Sterile urine culture before surgery, or previously positive urine culture that has been properly treated before intervention.
You likely can't join if
- Known hypersensitivity to aminophylline, theophylline, or ethylenediamine.
- Use of oral or intravenous aminophylline or theophylline within the previous 24 hours.
- Pre-existing ipsilateral JJ ureteral stent.
- Stone peeping at the ureteric orifice.
- Congenital or acquired abnormality that may affect distal ureteric access, such as ureterocele, obstructive megaureter, distal ureteric stricture...
- Known bladder dysfunction or conditions likely to affect normal bladder capacity.
See the full eligibility criteria
- Children older than 2 years and younger than 18 years.
- Single unilateral lower/distal ureteral stone confirmed by low-dose non-contrast computed tomography according to local policy.
- Stone size 5 to 15 mm.
- Candidate for definitive treatment by semi-rigid ureteroscopy.
- Sterile urine culture before surgery, or previously positive urine culture that has been properly treated before intervention.
- Intraoperative failed initial gentle negotiation of the ureteric orifice/intramural ureter according to the study definition.
- Written informed consent from the parent or legal guardian, with child assent when appropriate.
- Known hypersensitivity to aminophylline, theophylline, or ethylenediamine.
- Use of oral or intravenous aminophylline or theophylline within the previous 24 hours.
- Pre-existing ipsilateral JJ ureteral stent.
- Stone peeping at the ureteric orifice.
- Congenital or acquired abnormality that may affect distal ureteric access, such as ureterocele, obstructive megaureter, distal ureteric stricture, previous ureteric reimplantation, or previous ipsilateral ureteral...
- Known bladder dysfunction or conditions likely to affect normal bladder capacity.
- Multiple ipsilateral ureteral stones or associated renal stones requiring flexible ureteroscopy or a ureteral access sheath strategy.
- Febrile urinary tract infection, pyonephrosis, sepsis, or any case requiring urgent decompression instead of definitive ureteroscopy.
- Cardiac disease, arrhythmia, uncontrolled hypertension, hyperthyroidism, epilepsy or seizure disorder, or significant hepatic impairment.
- Inability to complete follow-up.
The study team makes the final eligibility decision.
Where it's taking place
- Banī Suwayf, Beni Suweif Governorate, Egypt
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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, 2 years to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Banī Suwayf, Beni Suweif Governorate, Egypt. 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.