Renal Stone Treatment Global Registry

NCT05297331 | Recruiting

• 1 other identifier: CRE-2021.684
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 3

Brief Summary

This is an international prospective data registry to assess the treatment outcomes and complications of different treatment approaches for different surgical treatment of urolithiasis.

Conditions

Urolithiasis

Keywords

Urolithiasis; ESWL; RIRS; flexible ureteroscopy; PCNL; FANS; flexible and navigable suction ureteral access sheath; intrarenal pressure; IRP; intrarenal temperature; IRT

Outcome Measures

Primary Outcomes (1)

• Target Stone status

  stone free rate

  postoperative, at 1 and/or 3 months

Secondary Outcomes (4)

• Intraoperative parameters

  intraoperative

• Treatment related complication

  Thirty days after the operation

• Recurrence of stone

  At 12 months

• QOL and pain scores

  preoperative, postoperative on day 0 and at follow up

Study Arms (5)

FLEXOR-FANS (flexible and navigable suction ureteral access sheath)

Cohort of flexible ureteroscopy with flexible and navigable suction ureteral access sheath (fURS FANS) will be studied

DISS (Direct in scope suction)

Cohort of flexible ureteroscopy with direct in scope suction (DISS) will be studied

Flexible ureteroscopy - IRP / IRT

Cohort of flexible ureteroscopy with and without real-time intrarenal pressure (IRP) monitoring and/or intrarenal temperature (IRT) will be studied

Shockwave lithotripsy (SWL)

Cohort of extracorporeal shockwave lithotripsy (SWL) will be studied

Percutaneous nephrolithotomy (PCNL)

Cohort of percutaneous nephrolithotomy with or without intrarenal pressure and temperature monitoring will be studied.

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

Patients diagnosed with urinary stones and planned for surgery (including shockwave lithotripsy, ureteroscopy, percutaneous nephrolithotomy (PCNL), laparoscopic ureterolithiasis, open stone procedures etc) in the hospitals will be identified and then enrolled to the study.

You may qualify if:

• Patient at the age of 18 or above

You may not qualify if:

• Patient is unable to give consent

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (3)

Alice Ho Miu Ling Nethersole Hospital

Hong Kong, Hong Kong

RECRUITING

Prince of Wales Hospital

Shatin, Hong Kong

RECRUITING

North District Hospital

Sheung Shui, Hong Kong

RECRUITING

Related Publications (15)

• Gauhar V, Traxer O, Fong KY, Sietz C, Chew BH, Bin Hamri S, Gokce MI, Gadzhiev N, Yuen SKK, Malkhasyan V, Ragoori D, Tanidir Y, Somani BK, Castellani D. Comparing Thulium Fiber Versus High-Power Holmium Laser Lithotripsy Combined with the Flexible and Navigable Suction Access Sheath in Flexible Ureteroscopy for Kidney Stone Disease: A Propensity Score Matched Analysis by the Global FANS Collaborative Group. J Endourol. 2025 Jan;39(1):42-49. doi: 10.1089/end.2024.0653. Epub 2024 Dec 16.

  PMID: 39676748 BACKGROUND

• Yuen SKK, Zhong W, Chan YS, Castellani D, Bhojani N, Agarwal MS, Tokas T, Croghan S, Jung H, Herrmann T, Somani B, Gauhar V; Global Research on Intra-renal Pressure Collaborative Group. Current utility, instruments, and future directions for intra-renal pressure management during ureteroscopy: scoping review by global research in intra-renal pressure collaborative group initiative. Ther Adv Urol. 2025 Jan 31;17:17562872251314809. doi: 10.1177/17562872251314809. eCollection 2025 Jan-Dec.

  PMID: 39896048 BACKGROUND

• Zhu W, Yuen SKK, Cao J, et al. Intrarenal pressure monitoring via flexible and navigable suction ureteral access sheath in retrograde intrarenal surgery: A preclinical animal study and a pilot clinical study. Clinical and Translational Discovery. 2025;5:e70031doi:10.1002/ctd2.70031

  BACKGROUND

• Nedbal C, Yuen SKK, Akram M, Keller EX, Martinez BB, Philip J, Emiliani E, Li JKM, Stracci D, Gauhar V, Castellani D, Somani BK. First clinical evaluation of a flexible digital ureteroscope with direct in scope suctioning system (Pusen DISS 7.5Ch): prospective multicentric feasibility study. World J Urol. 2024 Oct 3;42(1):560. doi: 10.1007/s00345-024-05275-9.

  PMID: 39361036 BACKGROUND

• Gauhar V, Traxer O, Castellani D, Sietz C, Chew BH, Fong KY, Hamri SB, Gokce MI, Gadzhiev N, Galosi AB, Yuen SKK, El Hajj A, Ko R, Zawadzki M, Sridharan V, Lakmichi MA, Corrales M, Malkhasyan V, Ragoori D, Soebhali B, Tan K, Chai CA, Tursunkulov AN, Tanidir Y, Persaud S, Elshazly M, Kamal W, Tefik T, Shrestha A, Tiong HC, Somani BK. Could Use of a Flexible and Navigable Suction Ureteral Access Sheath Be a Potential Game-changer in Retrograde Intrarenal Surgery? Outcomes at 30 Days from a Large, Prospective, Multicenter, Real-world Study by the European Association of Urology Urolithiasis Section. Eur Urol Focus. 2024 Dec;10(6):975-982. doi: 10.1016/j.euf.2024.05.010. Epub 2024 May 24.

  PMID: 38789313 BACKGROUND

• Yuen SKK, Traxer O, Wroclawski ML, Gadzhiev N, Chai CA, Lim EJ, Giulioni C, De Stefano V, Nedbal C, Maggi M, Sarica K, Castellani D, Somani B, Gauhar V. Scoping Review of Experimental and Clinical Evidence and Its Influence on Development of the Suction Ureteral Access Sheath. Diagnostics (Basel). 2024 May 16;14(10):1034. doi: 10.3390/diagnostics14101034.

  PMID: 38786332 BACKGROUND

• Talyshinskii A, Tzelves L, Ventimiglia E, Yuen SKK, Gauhar V, Traxer O, Somani B. Technological innovation and revolution with single-use digital flexible ureteroscopes: a review from section of EAU Endourology. Curr Opin Urol. 2025 Jul 1;35(4):360-367. doi: 10.1097/MOU.0000000000001260. Epub 2025 Jan 7.

  PMID: 39774241 BACKGROUND

• Gauhar V, Somani BK, Seitz C, Castellani D, Tefik T, Persaud S, Ragoori D, Gauhar V, Tan K, Lakmichi MA, Gadzhiev N, Malkhasyan V, Kamal W, Tanidir Y, Chai CA, Tursunkulov AN, Farahat Y, Keller EX, Chew BH, Herrmann T, Traxer O, Yuen SKK. A Global Survey to Assess Urologists' Attitudes Towards Suction Technology in Endourology by the European Association of Urology Section of Endourology and Progressive Endourological Association for Research and Leading Solutions. Urology. 2025 Mar;197:42-50. doi: 10.1016/j.urology.2024.12.009. Epub 2024 Dec 16.

  PMID: 39674378 BACKGROUND

• Chan SW, Ng CF, Man CW, Chung R, Li SK. A report on a randomly sampled questionnaire survey about renal stone disease in Hong Kong. Hong Kong Med J. 2008 Dec;14(6):427-31.

  PMID: 19060340 BACKGROUND

• Taguchi K, Cho SY, Ng AC, Usawachintachit M, Tan YK, Deng YL, Shen CH, Gyawali P, Alenezi H, Basiri A, Bou S, Djojodemedjo T, Sarica K, Shi L, Singam P, Singh SK, Yasui T. The Urological Association of Asia clinical guideline for urinary stone disease. Int J Urol. 2019 Jul;26(7):688-709. doi: 10.1111/iju.13957. Epub 2019 Apr 24.

  PMID: 31016804 BACKGROUND

• Li JK, Teoh JY, Ng CF. Updates in endourological management of urolithiasis. Int J Urol. 2019 Feb;26(2):172-183. doi: 10.1111/iju.13885. Epub 2018 Dec 21.

  PMID: 30575154 BACKGROUND

• Ng CF. The effect of age on outcomes in patients undergoing treatment for renal stones. Curr Opin Urol. 2009 Mar;19(2):211-4. doi: 10.1097/mou.0b013e32831e16b7.

  PMID: 19195134 BACKGROUND

• Anagnostou T, Thompson T, Ng CF, Moussa S, Smith G, Tolley DA. Safety and outcome of percutaneous nephrolithotomy in the elderly: retrospective comparison to a younger patient group. J Endourol. 2008 Sep;22(9):2139-45. doi: 10.1089/end.2007.0432.

  PMID: 18811570 BACKGROUND

• Ng CF, Wong A, Tolley DA. A single-center experience of the usefulness of caliceal-pelvic height in three different lithotripters. J Endourol. 2008 Jul;22(7):1409-15. doi: 10.1089/end.2006.0448.

  PMID: 18690807 BACKGROUND

• Ng CF, Luke S, Chiu PK, Teoh JY, Wong KT, Hou SS. The effect of renal cortical thickness on the treatment outcomes of kidney stones treated with shockwave lithotripsy. Korean J Urol. 2015 May;56(5):379-85. doi: 10.4111/kju.2015.56.5.379. Epub 2015 Apr 28.

  PMID: 25964839 BACKGROUND

MeSH Terms

Conditions

Urolithiasis

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Chi Fai NG, MD

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chi Fai NG, MD

CONTACT

35052625; ngcf@surgery.cuhk.edu.hk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 9, 2022
• First Posted: March 28, 2022
• Study Start: March 1, 2022
• Primary Completion (Estimated): December 31, 2032
• Study Completion (Estimated): March 31, 2033
• Last Updated: April 1, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

HK (3)