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| Name | Class |
|---|---|
| RetroPerc Inc | UNKNOWN |
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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.
Retrograde nephrostomy access is well established as a safe method for nephrostomy creation and thus this study aims to perform a standard of care study. The device is already available, on the shelf, and used in routine clinical care. However, the study aims to take a closer look in a prospective fashion at this access technique to better understand specific variables that are not available on retrospective review of cases that have already undergone PCNL with this technique.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RetroPerc® | Device | The RetroPerc® will be used to obtain renal access. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Location of Renal Access | The location of renal access was determined during the procedure. Location of access was defined as upper pole, mid pole, and lower pole. | Procedure |
| Time to gain renal access |
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Inclusion Criteria:
Exclusion Criteria:
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Participants undergoing percutaneous nephrolithotomy for treatment of their renal stone (s) total linear sum of 1.5 to 3cm cm in maximum dimension.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Research Program Manager | Contact | 913-588-8721 | jledesma2@kumc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Bristol Whiles, MD | University of Kansas Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of South Florida | Recruiting | Tampa | Florida | 33606 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 14713766 | Background | 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. | |
| 31037404 | 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. |
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De-identified participant data collected during the study
Following end of study
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.
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| ID | Term |
|---|---|
| D053040 | Nephrolithiasis |
| D007669 | Kidney Calculi |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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The time to gain renal access was defined as the time the ureteroscope enters the kidney to the time when the nephroscope enters the kidney
| Procedure |
| Total Procedure Time | The total procedure time is defined as the time when the cyso/urethroscope enters the urethra to the time time of skin closure. | Procedure |
| Length of Post-Operative Hospital Stay | The post-operative hospital length of stay range is defined from 0 days to longer than 5 days. | Day 0 to 3 Months Post-Operative |
| University of Kansas Medical Center | Recruiting | Kansas City | Kansas | 66105 | United States |
|
| 30515460 | 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. |
| 24779944 | 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. |
| 23219545 | 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. |
| 26558049 | 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. |
| 23251698 | 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. |
| Background | Smiths Textbook of Endourology. 2007, BC Decker Publ. Ch. 15, Dr. D. Hosking - "Retrograde Nephrostomy", Pg. 117. |
| 9107586 | 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. |
| 8775075 | 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. |
| 3373578 | 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. |
| 3686771 | 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. |
| 6649222 | 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. |
| 6649221 | 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. |
| D000091642 | Urogenital Diseases |
| D052878 | Urolithiasis |
| D052801 | Male Urogenital Diseases |
| D014545 | Urinary Calculi |
| D002137 | Calculi |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |