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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
3000 participants
OBSERVATIONAL
2022-03-01
2033-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Perioperative Parameter and Treatment Outcomes of ECIRS in Asia
NCT05894668
Ureteral Stenting After Ureteroscopy for Stone Treatment, A Global Perspective on Indications and Outcomes
NCT03567421
Treatment of Upper Urinary Tract Stones With a Diameter≤2cm by Intelligent Pressure-controlled Flexible Ureteroscope
NCT05201599
Comparison of the Efficacy of Flexible Ureteroscope and Percutaneous Nephroscopic Surgery in the Treatment of 2-4cm Kidney Stones
NCT06507176
Study on 'The Use of Non-contrast Helical Computerized Tomogram in Predicting Treatment Outcomes of Upper Ureteric Stone by Extracorporeal Shock Wave Lithotripsy Using the Sonolith 4000+ Lithotripter'
NCT00517205
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Different treatment approaches will result in different treatment successful rate and also potential adverse effects to patients. The main challenge for stone management is the decision on the best treatment approach for individual stone of each patient. This is because for the same type of stone (such as lower caliceal stone or upper ureteric stone), different surgical treatment could be applied. The decision will depend on various patients (such as age, premorbid etc.) and stone factors (such as size, density etc) and also patients' preference.
New advances in technology have improved treatment outcomes for urolithiasis, such as single use flexible ureteroscopes, flexible and navigable ureteral access sheaths (FANS), direct in scope suction (DISS), intrarenal pressure (IRP) and intrarenal temperature (IRT) monitoring devices, new lasers and pulse modulation, etc.
Therefore, in order to have more information to guide treatment decision during discussion with patients, a prospective data registry is created to assess the treatment outcomes and complications of different treatment approaches in our hospital clusters. This information will be important for audit, treatment comparison and also patient education.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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
No interventions assigned to this group
DISS (Direct in scope suction)
Cohort of flexible ureteroscopy with direct in scope suction (DISS) will be studied
No interventions assigned to this group
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
No interventions assigned to this group
Shockwave lithotripsy (SWL)
Cohort of extracorporeal shockwave lithotripsy (SWL) will be studied
No interventions assigned to this group
Percutaneous nephrolithotomy (PCNL)
Cohort of percutaneous nephrolithotomy with or without intrarenal pressure and temperature monitoring will be studied.
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Chinese University of Hong Kong
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Chi Fai NG
Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Chi Fai NG, MD
Role: PRINCIPAL_INVESTIGATOR
Chinese University of Hong Kong
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Alice Ho Miu Ling Nethersole Hospital
Hong Kong, , Hong Kong
Prince of Wales Hospital
Shatin, , Hong Kong
North District Hospital
Sheung Shui, , Hong Kong
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CRE-2021.684
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.