Actively Recruiting

Age: 18Years +
All Genders
ID07071831

RetroPerc®-A Prospective, Multi-institutional Trial of Efficacy of the RetroPerc Device in Percutaneous Nephrolithotomy for Renal Stones

Led by University of Kansas Medical Center · Updated on 2026-05-04

150

Participants Needed

2

Research Sites

34 weeks

Total Duration

On this page

Sponsors

U

University of Kansas Medical Center

Lead Sponsor

R

RetroPerc Inc

Collaborating Sponsor

AI-Summary

What this Trial Is About

The trial investigates the use of the RetroPerc® device to obtain renal access in patients undergoing percutaneous nephrolithotomy (PCNL) for renal stones. The goal is to better understand specific details of this access technique through a prospective observational study, as the device is already used in routine clinical care. Participants planned for PCNL as part of their usual care are invited to join the study. Participants with single or multiple renal stones totaling 1.5 to 3 cm in size will undergo PCNL using the RetroPerc® system in the supine position. The study is observational and does not alter standard care. It focuses on collecting detailed information about the procedure, including success rates of renal access and various procedure-related times. During the study, researchers will monitor how often renal access is successfully obtained, where the access is located, the time taken to gain access, total procedure time, and length of hospital stay after surgery. Participants will be assessed from the day of surgery up to three months post-operation. Data collection will include standard care evaluations without additional interventions beyond routine clinical practice.

CONDITIONS

Brief Title

RETRO Study (RETrograde Renal Access Outcomes)

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Have a single renal stone or multiple stones with a total size between 1.5 and 3 cm
  • Be 18 years of age or older
  • Be male or female
  • Scheduled for percutaneous nephrolithotomy in the supine position
  • Able to participate and follow the study procedures
  • All ethnic backgrounds are eligible reflecting geographic diversity
Not Eligible

You will not qualify if you...

  • Active pregnancy
  • Body mass index (BMI) over 45
  • Severe hydronephrosis with renal pelvis diameter greater than 20 mm
  • Flank window less than 4 cm making puncture impossible
  • Previous percutaneous nephrolithotomy on the same side
  • Current "useful" nephrostomy tube on the same side
  • Uncorrectable bleeding disorders
  • Untreated urinary tract infection
  • Significant health issues such as very high ASA score, severe spinal cord injuries, severe heart or lung problems, uncontrolled diabetes, neurological disorders, bedridden condition, life expectancy less than 5 years, or other high-risk conditions
  • Ipsilateral partial nephrectomy
  • History of ureteral reimplantation or reconstruction on the same side
  • History of prostatectomy or cystectomy
  • History of calyceal diverticula stone
  • History of kidney donation or transplant
  • Any pelvic surgery that increases risk or difficulty
  • Untreated ureteral strictures
  • Congenital abnormalities affecting the bladder, ureter, or kidney that prevent proper puncture or stone removal
  • Participation in other clinical trials within the last 3 months or planned during this study
  • Female participants who are breastfeeding or not using contraception if of childbearing potential
  • Current or recent substance abuse requiring intervention
  • Prisoners or wards of the state
  • Unable to meet treatment and follow-up requirements

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - Day of procedure

Participants undergo percutaneous nephrolithotomy as part of their routine medical care using the RetroPerc® system to obtain renal access.

1 visit (in-person)

Post-operative Follow-up

Duration - Up to 3 months post-operative

Participants are monitored for recovery and outcomes after the procedure.

Approximately 3 visits (in-person)

Trial Site Locations

Total: 2 locations

1

University of South Florida

Tampa, Florida, United States, 33606

Actively Recruiting

2

University of Kansas Medical Center

Kansas City, Kansas, United States, 66105

Actively Recruiting

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Research Team

R

Research Program Manager

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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Published Research Related To This Trial

A New Twist on an Old Technique: Lawson Retrograde Endoscopic-Guided Nephrostomy Access for Percutaneous Nephrolithotomy in Prone Split-Leg Position.

Kamaljot S Kaler, Egor Parkhomenko, Cyrus Y Lin...

https://pubmed.ncbi.nlm.nih.gov/30515460