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UrolithiasisNCT05297331

Renal Stone Treatment Global Registry

An observational study of Urolithiasis, run by Chinese University of Hong Kong at 3 sites in Hong Kong.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Urolithiasis
How many people
3,000 participants
Where
3 sitesHong Kong
Study dates
1 Mar 2022to 31 Mar 2033
How long will I take part?
1 Year
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • Patient at the age of 18 or above

Who cannot join

  • Patient is unable to give consent

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Chi Fai NG, MD contact

35052625

ngcf@surgery.cuhk.edu.hk

Hong Kong3 sites, 3 recruiting
  • Alice Ho Miu Ling Nethersole Hospital

    Hong Kong

    Chi Fai NG, MD, 35052625, ngcf@surgery.cuhk.edu.hk

    Recruiting
  • Prince of Wales Hospital

    Shatin

    Chi Fai NG, MD, 3505 2625, ngcf@surgery.cuhk.edu.hk

    Recruiting
  • North District Hospital

    Sheung Shui

    Chi Fai NG, MD, 3505-2625, ngcf@surgery.cuhk.edu..hk

    Recruiting

Other trials in Hong Kong

About this study

Official title: A Prospective Assessment of the Perioperative Parameter and Treatment Outcomes of Urinary Calculi - International Registry

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

Read the detailed description

Renal stone is a common condition, and many patients suffered from recurrent diseases and required multiple interventions in their lifetime. Currently, there are many treatment options available for stone treatment, including shockwave lithotripsy, ureteroscopy, percutaneous nephrolithotomy etc.

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
Urolithiasis
Keywords
Urolithiasis, ESWL, RIRS, flexible ureteroscopy, PCNL, FANS, flexible and navigable suction ureteral access sheath, intrarenal pressure, IRP, intrarenal temperature, IRT
Medical subject headings
Urolithiasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT05297331
Study groupRoleWhat they receive
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 / IRTCohort 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Target Stone status

    stone free rate

    Measured: postoperative, at 1 and/or 3 months

Secondary outcomes (4)
  1. Intraoperative parameters

    Including irrigation and suction and laser settings and devices, laser consumption and efficacy, fluoroscopy dosage and time, equipment (ureteral access sheath size and lengths, ureteroscopy sizes, stone basket) utilised; exit strategy; intraoperative complications if noted; ergonomics

    Measured: intraoperative

  2. Treatment related complication

    The 30-day complications will be graded according to the Clavien-Dindo classification

    Measured: Thirty days after the operation

  3. Recurrence of stone

    Stone recurrence rate

    Measured: At 12 months

  4. QOL and pain scores

    Pain VAS scores and QOL assessment

    Measured: preoperative, postoperative on day 0 and at follow up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Mar 2022
  2. Study start1 Mar 2022
  3. Primary completion31 Dec 2032 (estimated)
  4. Study completion31 Mar 2033 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
3,000 participants (estimated)
Target duration
1 Year
IDs, dates and publications
ClinicalTrials.gov ID
NCT05297331
Sponsor's protocol ID
CRE-2021.684
Status last verified
Oct 2026
First submitted
9 Mar 2022
Last updated
22 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 39676748
  • 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.

    PubMed 39896048
  • 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.

    PubMed 39361036
  • 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.

    PubMed 38789313
  • 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.

    PubMed 38786332
  • 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.

    PubMed 39774241
  • 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.

    PubMed 39674378
  • 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.

    PubMed 19060340
  • 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.

    PubMed 31016804
  • 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.

    PubMed 30575154
  • 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.

    PubMed 19195134
  • 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.

    PubMed 18811570
  • 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.

    PubMed 18690807
  • 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.

    PubMed 25964839

Questions about this trial

What is this clinical trial studying?

An observational study of Urolithiasis, run by Chinese University of Hong Kong at 3 sites in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Chi Fai NG, MD (35052625, ngcf@surgery.cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Target Stone status (time frame: postoperative, at 1 and/or 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05297331, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.

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Renal Stone Treatment Global Registry (NCT05297331) | AzTrials