Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
150 participants
OBSERVATIONAL
2024-12-06
2026-12-31
Brief Summary
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Participants who are already scheduled to undergo percutaneous nephrolithotomy as part of their regular care will be asked to participate.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
RetroPerc®
The RetroPerc® will be used to obtain renal access.
Interventions
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RetroPerc®
The RetroPerc® will be used to obtain renal access.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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RetroPerc Inc
UNKNOWN
University of Kansas Medical Center
OTHER
Responsible Party
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Bristol Whiles, MD
Assistant Professor
Principal Investigators
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Bristol Whiles, MD
Role: PRINCIPAL_INVESTIGATOR
University of Kansas Medical Center
Locations
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University of South Florida
Tampa, Florida, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
Smiths Textbook of Endourology. 2007, BC Decker Publ. Ch. 15, Dr. D. Hosking - "Retrograde Nephrostomy", Pg. 117.
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.
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.
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.
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.
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.
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.
Other Identifiers
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STUDY00160854
Identifier Type: -
Identifier Source: org_study_id
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