Recruiting

Observational Study

Sponsor:

University of Kansas Medical Center

Code:

NCT07071831

Conditions

Renal Stones

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

RetroPerc®

Study Details

Brief summary:

The goal of this observational study is to learn about the benefit of using RetroPerc® in obtaining renal access for percutaneous nephrolithotomy. The device is already used in routine clinical practice by urologists around the country.

Participants who are already scheduled to undergo percutaneous nephrolithotomy as part of their regular care will be asked to participate.

Conditions

Renal Stones

Study ID

NCT07071831

Start date

Dec 6, 2024

Status verified date

May, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Apr, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

150 participants

Anticipated

Interventions and Outcome Measures

Arms

Percutaneous Nephrolithotomy

Participants with a single renal stone or total sum of 1.5 to 3 cm in maximum dimension of multiple stones undergoing percutaneous nephrolithotomy as part of their routine medical care using the RetroPerc® system to obtain renal access.

Interventions

RetroPerc®

The RetroPerc® will be used to obtain renal access.

Primary outcome measure

  • Proportion of successful renal access per access attempts [ Time Frame: Procedure ]

Central Contacts and Locations

Central contacts

Research Program Manager

913-588-8721jledesma2@kumc.edu

Locations

University of South Florida

Recruiting

Tampa, Florida, United States, 33606

Contacts

Renya Maku

813-821-8035rmaku@tgh.org

Principal Investigator:

David Hernandez, MD

University of Kansas Medical Center

Recruiting

Kansas City, Kansas, United States, 66105

Contacts

Research Program Manager

913-588-8721jledesma2@kumc.edu

Principal Investigator:

Bristol Whiles, MD

More Information

Sponsor

University of Kansas Medical Center

Last update posted

May 4, 2026

Last verified

May, 2026

Keywords

  • kidney stones

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Kansas Medical Center on 2026-05-04.