BridgeMD
Compares treatment options for Nephrolithiasis
Official title Comparison Between Ureterorenoscopy With Lithotripsy Alone Versus Combination With Hydrogel for Kidney Stone Removal
ClinicalTrials.gov ID: NCT06469736
What this study is testing
- What it's testing
- The incidence of kidney stones (urolithiasis) has surged in both developing and developed countries, affecting approximately 15% of the global population. From 2010 to 2019, diagnoses of kidney and ureteral stones rose by 8% in Germany, 26% in France, and 15% in England.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Male or female people aged ≥ 18 years
- Evidence of nephrolithiasis on presentation of a preoperative computer tomography (CT) scan not older than 6 months
- Minimum size of the kidney stones defined as \>10mm in the longest axis in the preoperative CT.
- Ability to read, write and speak German
- Women of childbearing age must have a negative serum pregnancy test at the start of the study.
You likely can't join if
- Participation in another clinical trial for kidney stone removal in the last 6 months
- people with gastrointestinal cancer who have not been in remission for at least 2 years
- people with a single kidney, horseshoe kidney or other anatomical abnormalities that may increase the risk of surgery for the subject
- people with untreated ureteral stenosis or renal stenosis and narrow ureteropelvic junction/ureterovesical junction
- people with known impaired renal function from stage IV or known dialysis
- people with chronic hydronephrosis not associated with nephrolithiasis
See the full eligibility criteria
- Male or female people aged ≥ 18 years
- Evidence of nephrolithiasis on presentation of a preoperative computer tomography (CT) scan not older than 6 months
- Minimum size of the kidney stones defined as \>10mm in the longest axis in the preoperative CT.
- Ability to read, write and speak German
- Women of childbearing age must have a negative serum pregnancy test at the start of the study.
- Submission of a personally signed and dated informed consent form stating that the subject has been informed of all relevant aspects of the study prior to any trial-related activity and that all information has been...
- Participation in another clinical trial for kidney stone removal in the last 6 months
- people with gastrointestinal cancer who have not been in remission for at least 2 years
- people with a single kidney, horseshoe kidney or other anatomical abnormalities that may increase the risk of surgery for the subject
- people with untreated ureteral stenosis or renal stenosis and narrow ureteropelvic junction/ureterovesical junction
- people with known impaired renal function from stage IV or known dialysis
- people with chronic hydronephrosis not associated with nephrolithiasis
- people with the following known or suspected diseases: Coagulation disorders, untreated urinary tract infections, renal disease sepsis and marked prostatic hyperplasia
- people with any other disease or condition that, in the opinion of the investigator, could interfere with the purpose of the study (e.g. bleeding that restricts vision in the kidney, problems in the renal tubular system)
- Breastfeeding or pregnant women
- people who may be part of a vulnerable group (e.g. prisoners or developmentally delayed adults)
The study team makes the final eligibility decision.
Where it's taking place
- Munich, Bavaria, Germany
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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Munich, Bavaria, Germany. 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.