New tool aims to make kidney stone removal safer
NCT ID NCT07071831
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study is testing a device called RetroPerc, which helps doctors reach kidney stones during surgery. About 150 adults with kidney stones will take part. The goal is to see how often the device successfully gets to the stone and how long it takes.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- RetroPerc device
- What this could lead to
- If successful, this study could confirm that the RetroPerc device is a reliable tool for kidney stone surgery, potentially making the procedure safer and more efficient.
- What could go wrong
- This is an observational study, not a controlled trial, so it cannot prove the device is better than other methods. Results may not apply to all patients or settings.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 150 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2024
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Participants undergoing percutaneous nephrolithotomy for treatment of their renal stone (s) total linear sum of 1.5 to 3cm cm in maximum dimension.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Renal stone or total linear sum of 1.5-3cm cm in maximum dimension (largest diameter in axial or coronal)--- multiple stones should be summed to determine stone size. * Age \>=18 years of age * Gender: both men and women included. * Ethnic background: all ethnicities will be included in the study population and the specific ethnic diversity present in the study population will reflect the geographic distributions of the participating institutions. * Plan for PCNL in the supine position Exclusion Criteria: * Active pregnancy * BMI \>45 * Severe Hydronephrosis - renal pelvis diameter \> 20mm * Flank window \< 4 cm are ineligible for puncture * Previous ipsilateral PCNL * Currently with "useful" nephrostomy tube on ipsilateral side * Uncorrectable coagulopathies * Untreated urinary tract infection * Subjects with significant morbidities such as American Society of Anesthesiologists (ASA) score ≥ 4, severe spinal cord injuries, severe cardiopulmonary insufficiency, uncontrolled diabetes, neurological disorders, bedbound, anticipated life expectancy less than 5 years, or any other comorbidity, that in the opinion of the principal investigator could represent an increased peri-operative risk for the subject; * Ipsilateral partial nephrectomy * History of ipsilateral ureteral reimplantation or ureteral reconstruction; * History of Simple or radical prostatectomy * History of cystectomy * History of calyceal diverticula stone; * History of renal donation or transplant; * Any other previous pelvic surgical treatment that could put the subject at greater procedural complication risk or technical difficulty; * Ureteral ipsilateral stricture, untreated; * Ureteral stricture, untreated (not to include "tight" ureter); * Any other bladder, ureteral or kidney congenital genitourinary abnormalities (e.g. Horseshoe kidney, ipsilateral duplicated or partially duplicated collecting system, ipsilateral ectopic kidney, cross-fused ectopia, bifid renal pelvis with no horizontally directed calyces, solitary kidney, etc.) preventing the ability to direct a puncture laterally or render the subject stone free; * Have participated in any other clinical trial within the last 3 months, and/or plans to participate in any other investigational or invasive clinical trial during this study; * If female, breast-feeding, or if childbearing age, is not using contraception between screening and 90 days post-op; * Subject has current or recent history of substance abuse (e.g. recreational drugs, narcotics, or alcohol) requiring intervention; * Is a prisoner or ward of the state; * Is unable to meet the treatment and follow up protocol requirements.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University of Kansas Medical Center
RECRUITINGKansas City, Kansas, 66105, United States
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University of South Florida
RECRUITINGTampa, Florida, 33606, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Kidney stone surgery without the stent: a new study asks if It's safe
- Can a simple tool predict who will be Stone-Free after kidney surgery?
- Which kidney stone technique leaves no stone behind?
- Which surgery is safer for a single kidney with stones? a Head-to-Head trial
- New combo therapy may simplify kidney stone removal
- Kidney stone patients may skip stent after surgery, study hints