RETRO Study (RETrograde Renal Access Outcomes)

NCT07071831 | Recruiting

• 1 other identifier: STUDY00160854
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 2

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

Keywords

kidney stones

Outcome Measures

Primary Outcomes (1)

• Proportion of successful renal access per access attempts

  The proportion of successful renal access was compared to the renal access attempts (e.g. 100 success attempts/110 attempts).

  Procedure

Secondary Outcomes (4)

• Location of Renal Access

  Procedure

• Time to gain renal access

  Procedure

• Total Procedure Time

  Procedure

• Length of Post-Operative Hospital Stay

  Day 0 to 3 Months Post-Operative

Study Arms (1)

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.

Device: RetroPerc®

Interventions

RetroPerc® DEVICE

The RetroPerc® will be used to obtain renal access.

Percutaneous Nephrolithotomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants undergoing percutaneous nephrolithotomy for treatment of their renal stone (s) total linear sum of 1.5 to 3cm cm in maximum dimension.

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• University of Kansas Medical Center: lead
• RetroPerc Inc: collaborator

Study Sites (2)

University of South Florida

Tampa, Florida, 33606, United States

RECRUITING

University of Kansas Medical Center

Kansas City, Kansas, 66105, United States

RECRUITING

Related Publications (14)

• Lee CL, Anderson JK, Monga M. Residency training in percutaneous renal access: does it affect urological practice? J Urol. 2004 Feb;171(2 Pt 1):592-5. doi: 10.1097/01.ju.0000104849.25168.6d.

  PMID: 14713766 BACKGROUND

• Alotaibi KM. Retrograde nephrostomy access for percutaneous nephrolithotomy: a simple and safe technique. Urolithiasis. 2020 Apr;48(2):175-181. doi: 10.1007/s00240-019-01135-z. Epub 2019 Apr 29.

  PMID: 31037404 BACKGROUND

• Kaler KS, Parkhomenko E, Lin CY, Valley ZA, Kim WK, Okhunov Z, Patel RM, Landman J. A New Twist on an Old Technique: Lawson Retrograde Endoscopic-Guided Nephrostomy Access for Percutaneous Nephrolithotomy in Prone Split-Leg Position. J Endourol Case Rep. 2018 Nov 29;4(1):190-194. doi: 10.1089/cren.2018.0073. eCollection 2018.

  PMID: 30515460 BACKGROUND

• Wynberg JB, Paik LJ, Odom BD, Kruger M, Atalla CS. Body mass index predicts outcome of ureteroscopy-assisted retrograde nephrostomy for percutaneous nephrolithotomy. J Endourol. 2014 Sep;28(9):1071-7. doi: 10.1089/end.2014.0204. Epub 2014 Jun 12.

  PMID: 24779944 BACKGROUND

• Sivalingam S, Al-Essawi T, Hosking D. Percutaneous nephrolithotomy with retrograde nephrostomy access: a forgotten technique revisited. J Urol. 2013 May;189(5):1753-6. doi: 10.1016/j.juro.2012.11.169. Epub 2012 Dec 3.

  PMID: 23219545 BACKGROUND

• Al-Otaibi KM. Retrograde upper-pole calyceal access for percutaneous nephrolithotripsy of stones in the lower-pole calyx. Arab J Urol. 2012 Dec;10(4):353-7. doi: 10.1016/j.aju.2012.08.002. Epub 2012 Sep 23.

  PMID: 26558049 BACKGROUND

• Kawahara T, Ito H, Terao H, Kato Y, Uemura H, Kubota Y, Matsuzaki J. Effectiveness of ureteroscopy-assisted retrograde nephrostomy (UARN) for percutaneous nephrolithotomy (PCNL). PLoS One. 2012;7(12):e52149. doi: 10.1371/journal.pone.0052149. Epub 2012 Dec 14.

  PMID: 23251698 BACKGROUND

• Smiths Textbook of Endourology. 2007, BC Decker Publ. Ch. 15, Dr. D. Hosking - "Retrograde Nephrostomy", Pg. 117.

  BACKGROUND

• Mokulis JA, Peretsman SJ. Retrograde percutaneous nephrolithotomy using the Lawson technique for management of complex nephrolithiasis. J Endourol. 1997 Apr;11(2):125-30. doi: 10.1089/end.1997.11.125.

  PMID: 9107586 BACKGROUND

• Wong HY, Hinson JL, Griffith DP. Retrograde nephrostomy: advantages, disadvantages, and the learning curve. J Endourol. 1995 Dec;9(6):461-3. doi: 10.1089/end.1995.9.461.

  PMID: 8775075 BACKGROUND

• Morrisseau PM, Trotter SJ. Retrograde percutaneous nephrolithotomy: urological treatment of a urological problem. J Urol. 1988 Jun;139(6):1163-5. doi: 10.1016/s0022-5347(17)42847-3.

  PMID: 3373578 BACKGROUND

• Spirnak JP, Resnick MI. Retrograde percutaneous stone removal using modified Lawson technique. Urology. 1987 Dec;30(6):551-3. doi: 10.1016/0090-4295(87)90434-1.

  PMID: 3686771 BACKGROUND

• Hunter PT, Hawkins IF, Finlayson B, Nanni G, Senior D. Hawkins-Hunter retrograde transcutaneous nephrostomy: a new technique. Urology. 1983 Dec;22(6):583-7. doi: 10.1016/0090-4295(83)90300-x.

  PMID: 6649222 BACKGROUND

• Lawson RK, Murphy JB, Taylor AJ, Jacobs SC. Retrograde method for percutaneous access to kidney. Urology. 1983 Dec;22(6):580-2. doi: 10.1016/0090-4295(83)90299-6.

  PMID: 6649221 BACKGROUND

MeSH Terms

Conditions

Nephrolithiasis; Kidney Calculi

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Male Urogenital Diseases; Urinary Calculi; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Bristol Whiles, MD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Research Program Manager

CONTACT

913-588-8721; jledesma2@kumc.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 8, 2025
• First Posted: July 17, 2025
• Study Start: December 6, 2024
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 4, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, CSR
• Time Frame: Following end of study
• Access Criteria: Data may be requested by participating study investigators. The participating sites must have a data use agreement in place before requesting access to the data.

Locations

US (2)