Actively Recruiting
RETRO Study (RETrograde Renal Access Outcomes)
Led by University of Kansas Medical Center · Updated on 2026-05-04
150
Participants Needed
2
Research Sites
155 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 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
Official Title
RETRO Study (RETrograde Renal Access Outcomes)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Renal stone or total linear sum of stones measuring 1.5 to 3 cm in maximum dimension
- Age 18 years or older
- Both men and women are included
- All ethnic backgrounds are eligible reflecting geographic diversity
- Plan to have percutaneous nephrolithotomy in the supine position
You will not qualify if you...
- Active pregnancy
- Body mass index (BMI) greater than 45
- Severe hydronephrosis with renal pelvis diameter over 20 mm
- Flank window less than 4 cm making puncture ineligible
- Previous percutaneous nephrolithotomy on the same side
- Currently having a useful nephrostomy tube on the same side
- Uncorrectable bleeding disorders
- Untreated urinary tract infection
- Significant health problems increasing surgical risk, such as severe spinal cord injuries, severe heart or lung problems, uncontrolled diabetes, neurological disorders, being bedbound, or life expectancy less than 5 years
- Previous partial kidney removal on the same side
- History of ureteral reimplantation or reconstruction on the same side
- History of prostate removal surgery
- History of bladder removal
- History of calyceal diverticula stone
- History of kidney donation or transplant
- Any prior pelvic surgery increasing risk or technical difficulty
- Untreated ureteral strictures on the same side
- Any other significant congenital urinary tract abnormalities preventing proper puncture or stone removal
- Participation in other clinical trials within the last 3 months or planned participation during this study
- If female, breastfeeding or not using contraception between screening and 90 days after surgery
- Current or recent substance abuse requiring intervention
- Being a prisoner or ward of the state
- Unable to follow treatment and follow-up protocols
AI-Screening
AI-Powered Screening
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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
Research Team
R
Research Program Manager
CONTACT
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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