Kidney StonesFLAMENCT07159035
Flexible Ureteroscopy With a Flexible and Navigable Suction Ureteral Access Sheath Versus Mini-Percutaneous Nephrolithotomy for 1-2 cm Lower Pole Kidney Stones
A study testing Flexible ureteroscopy with FANS and Mini-percutaneous nephrolithotomy (mini-PCNL) in people with Kidney Stones, run by The First Affiliated Hospital of Guangzhou Medical University at 1 site in China.
Trial summary
This study, known as the FLAME Trial (Flexible ureteroscopy for Lower pole stones And Mini-pErcutaneous nephrolithotomy), is an international, multicenter, randomized, non-inferiority trial. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Kidney Stones
- What is being tested?
- Flexible ureteroscopy with FANS and Mini-percutaneous nephrolithotomy (mini-PCNL)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 640 participants
- Where
- 1 siteChina
- Study dates
- 28 Aug 2025to 10 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18-75 years;
- American Society of Anesthesiology (ASA) score 1-3;
- Lower pole renal stones-single or multiple-with a maximal diameter of 1-2 cm confirmed by CT;
- Ability to provide written informed consent and adhere to trial requirements.
Who cannot join
- Significant urinary tract anatomical anomalies (e.g. horseshoe kidney, ileal conduit);
- Stones located within a calyceal diverticulum;
- History of open nephrolithotomy or ureterolithomy (due to resultant intrarenal anatomical distortion);
- Absolute contraindications to either FANS-f-URS or mini-PCNL, including:
- Uncorrectable coagulopathy;
- Active, uncontrolled urinary tract infection;
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- Severe cardiopulmonary disease precluding safe general anesthesia (e.g. decompensated heart failure, refractory COPD);
- Pregnancy;
- Inability to tolerate lithotomy or prone positioning;
- Inability to understand or complete trial documentation.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510230
About this study
Official title: Flexible Ureteroscopy With a Flexible and Navigable Suction Ureteral Access Sheath Versus Mini-Percutaneous Nephrolithotomy for 1-2 cm Lower Pole Renal Stones: an International, Multicenter, Randomized Non-Inferiority Trial (FLAME Trial)
This study, known as the FLAME Trial (Flexible ureteroscopy for Lower pole stones And Mini-pErcutaneous nephrolithotomy), is an international, multicenter, randomized, non-inferiority trial. It aims to compare the effectiveness and safety of flexible ureteroscopy using a flexible and navigable suction ureteral access sheath (FANS) versus mini-percutaneous nephrolithotomy (mini-PCNL) in the treatment of 1-2 cm lower pole kidney stones.
A total of 640 eligible adult patients will be enrolled across 20 high-volume urology centers in China, Russia, Turkey, and India. Participants will be randomly assigned to undergo either FANS-assisted flexible ureteroscopy or mini-PCNL. The primary outcome is the immediate stone-free rate (SFR) assessed by non-contrast CT within 72 hours after surgery. Secondary outcomes include SFR at 1 month, operative time, pain score, length of hospital stay, complication rates, and changes in health-related quality of life.
The goal of this trial is to determine whether the less invasive FANS-assisted approach is non-inferior to mini-PCNL in terms of efficacy, while potentially offering advantages in postoperative recovery and safety.
Read the detailed description
The FLAME Trial (Flexible ureteroscopy for Lower pole stones And Mini-pErcutaneous nephrolithotomy) is an international, multicenter, prospective, randomized, controlled, non-inferiority study that aims to evaluate the safety and efficacy of flexible ureteroscopy assisted by a Flexible and Navigable Suction Ureteral Access Sheath (FANS) compared with mini-percutaneous nephrolithotomy (mini-PCNL) in the treatment of 1-2 cm lower pole renal stones.
This trial will enroll 640 patients from 20 urology centers with substantial experience in endoscopic stone surgery, including hospitals in China, Russia, Turkey, and India. Eligible participants will be randomly assigned in a 1:1 ratio to either the FANS-assisted flexible ureteroscopy group or the mini-PCNL group. All patients will undergo preoperative imaging, intraoperative standardization, and postoperative follow-up according to the study protocol.
The primary endpoint is the stone-free rate (SFR) within 72 hours postoperatively, evaluated by non-contrast-enhanced computed tomography (NCCT). Secondary endpoints include SFR at 1 month, operative time, length of hospital stay, postoperative pain (measured by VAS score), complication rates (graded by Clavien-Dindo classification), changes in renal function, and health-related quality of life (HRQoL).
The FANS, developed to improve irrigation control and active stone fragment suction during flexible ureteroscopy, may provide better visualization, reduce intrarenal pressure, and shorten operative time. By directly comparing FANS-assisted fURS with mini-PCNL, the trial seeks to determine whether a less invasive method can achieve comparable outcomes in terms of stone clearance and complication rates.
- Conditions
- Kidney Stones
- Being tested
- Flexible ureteroscopy with FANS, Mini-percutaneous nephrolithotomy (mini-PCNL)
- Keywords
- kidney stones, FANS, PCNL, RIRS, flexible ureteroscopy
- Medical subject headings
- Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flexible ureteroscopy with FANSProcedure or surgery
The FANS with negative-pressure suction, enhancing intrarenal pressure control and fragment evacuation during flexible ureteroscopy.
Mini-percutaneous nephrolithotomy (mini-PCNL)Procedure or surgery
Mini-PCNL is performed under general anesthesia with less than 20 Fr access tract, using rigid nephroscopy and stone fragmentation under direct visualization. Postoperative drainage is provided via nephrostomy or ureteral stent as per protocol.
| Study group | Role | What they receive |
|---|---|---|
| FANS-fURS Group | Experimental | Patients assigned to this group will undergo flexible ureteroscopy with FANS (Flexible endoscopy-Assisted Negative-pressure Suction Sheath). The FANS facilitates direct stone visualization, fragmentation, suction, and removal under controlled pressure conditions. Receives: Procedure: Flexible ureteroscopy with FANS |
| mini-PCNL Group | Active comparator | Patients in this group will receive mini-percutaneous nephrolithotomy (mini-PCNL) via less than 20 Fr percutaneous tracts. Receives: Procedure: Mini-percutaneous nephrolithotomy (mini-PCNL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immediate Stone-Free Rate (SFR)
Stone-free status will be evaluated using non-contrast-enhanced computed tomography (NCCT) performed within 72 hours after surgery. Stone-free is defined as the absence of residual stone fragments or presence of clinically insignificant fragments ≤2 mm.
Measured: 72 hours after surgery
Secondary outcomes (6)
Final Stone-Free Rate (SFR) at 1 Month
Assessed by low-dose CT scan. Patients with no residual stones or with residual fragments ≤2 mm are defined as stone-free.
Measured: 1 month after surgery
Operative Time
For the FANS-fURS group, operative time is defined as the duration from insertion of the endoscope into the urethra to completion of stent placement.
For the mini-PCNL group, it is defined as the time from retrograde placement of the ureteric catheter to nephrostomy tube placement or percutaneous access removal.
Measured: Intraoperative
Postoperative Pain Level
Evaluated using the 10-point Visual Analog Scale (VAS), where 0 indicates no pain and 10 indicates worst pain.
Measured: Within 24 hours after surgery.
Length of Hospital Stay
From surgery to discharge.
Measured: From the day of surgery until the day of discharge, assessed up to 30 days postoperatively.
Complication Rate Within 1 Month
All postoperative complications will be recorded and graded using the Clavien-Dindo classification system.
Measured: 1 month after surgery.
Change in Quality of Life Score
Assessed using the Wisconsin Stone Quality of Life (WISQOL) questionnaire before surgery and at 1-month follow-up.
Measured: Baseline and 1 month after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2025
- Study start28 Aug 2025
- Primary completion1 May 2026
- Study completion10 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Kidney StonesStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Guangzhou Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized in a 1:1 ratio to undergo either FANS-assisted flexible ureteroscopy or mini-percutaneous nephrolithotomy for the treatment of 1-2 cm lower pole renal stones. This is a multicenter, international, randomized, non-inferiority trial.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 640 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Shengjing Hospital, The Third Xiangya Hospital of Central South University, Saint Petersburg State University Hospital, Fortune Urology Clinic, Zhongda Hospital, Tongji Hospital, The First Affiliated Hospital Hengyang Medical School, First Affiliated Hospital of Ningbo University, The Sixth Affiliated Hospital of Guangzhou Medical University, The First Affiliated Hospital of Xiamen University, Dehong People's Hospital, Nanhai District People's Hospital, Huadu District People's Hospital of Guangzhou, Jiangmen Central Hospital, Yunnan Baoshan Second People's Hospital, Guizhou Provincial People's Hospital, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Tianjin Medical University Second Hospital, Ankara University
- Responsible party
- Principal investigator, Guohua Zeng, The First Affiliated Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07159035
- Sponsor's protocol ID
- ES-2025-181
- Acronym
- FLAME
- Status last verified
- Jul 2026
- First submitted
- 28 Aug 2025
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared due to institutional policy restrictions and data privacy considerations.
Publications
Skolarikos A, Geraghty R, Somani B, Tailly T, Jung H, Neisius A, Petrik A, Kamphuis GM, Davis N, Bezuidenhout C, Lardas M, Gambaro G, Sayer JA, Lombardo R, Tzelves L. European Association of Urology Guidelines on the Diagnosis and Treatment of Urolithiasis. Eur Urol. 2025 Jul;88(1):64-75. doi: 10.1016/j.eururo.2025.03.011. Epub 2025 Apr 22.
PubMed 40268592Zhu W, Zhong J, Wang K, Yin G, Leung CH, Gadzhiev N, Gokce MI, Kalathia J, Gauhar V, Zhang G, Wu G, Li M, Fang L, Zeng S, Bai P, Li J, Zhao Z, Xi M, Mai X, Duan X, Jiang K, Cao J, Meng X, Liu S, Aloyan A, Yuan P, Zhu X, Huang T, Xing J, Du J, Wu W, Ma J, Zhong W, Zhao Z, Liu Y, Ng CF, de la Rosette J, Somani B, Qi S, Zeng G, Yuen SKK. Flexible ureteroscopy with a flexible and navigable suction ureteral access sheath versus mini-percutaneous nephrolithotomy for 1-2 cm lower pole renal stones: Protocol for an international, multicentre, randomized non-inferiority trial (FLAME trial). BJUI Compass. 2025 Nov 29;6(12):e70114. doi: 10.1002/bco2.70114. eCollection 2025 Dec.
PubMed 41323963
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Flexible Ureteroscopy With a Flexible and Navigable Suction Ureteral Access Sheath Versus Mini-Percutaneous Nephrolithotomy for 1-2 cm Lower Pole Renal Stones: an International, Multicenter, Randomized Non-Inferiority Trial (FLAME Trial)
- ClinicalTrials.gov ID
- NCT07159035
- Acronym / sponsor ID
- FLAME / ES-2025-181
- Conditions
- Kidney Stones
- Keywords
- kidney stones, FANS, PCNL, RIRS, flexible ureteroscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 640 participants (actual)
- Lead sponsor
- The First Affiliated Hospital of Guangzhou Medical UniversityUniversity, hospital or other
- Collaborators
- Shengjing Hospital, The Third Xiangya Hospital of Central South University, Saint Petersburg State University Hospital, Fortune Urology Clinic, Zhongda Hospital, Tongji Hospital, The First Affiliated Hospital Hengyang Medical School, First Affiliated Hospital of Ningbo University, The Sixth Affiliated Hospital of Guangzhou Medical University, The First Affiliated Hospital of Xiamen University, Dehong People's Hospital, Nanhai District People's Hospital, Huadu District People's Hospital of Guangzhou, Jiangmen Central Hospital, Yunnan Baoshan Second People's Hospital, Guizhou Provincial People's Hospital, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Tianjin Medical University Second Hospital, Ankara University
- Study start
- 28 Aug 2025 (actual)
- Primary completion
- 1 May 2026 (actual)
- Study completion
- 10 Jun 2026 (actual)
- First posted
- 8 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study, known as the FLAME Trial (Flexible ureteroscopy for Lower pole stones And Mini-pErcutaneous nephrolithotomy), is an international, multicenter, randomized, non-inferiority trial. It aims to compare the effectiveness and safety of flexible ureteroscopy using a flexible and navigable suction ureteral access sheath (FANS) versus mini-percutaneous nephrolithotomy (mini-PCNL) in the treatment of 1-2 cm lower pole kidney stones.
A total of 640 eligible adult patients will be enrolled across 20 high-volume urology centers in China, Russia, Turkey, and India. Participants will be randomly assigned to undergo either FANS-assisted flexible ureteroscopy or mini-PCNL. The primary outcome is the immediate stone-free rate (SFR) assessed by non-contrast CT within 72 hours after surgery. Secondary outcomes include SFR at 1 month, operative time, pain score, length of hospital stay, complication rates, and changes in health-related quality of life.
The goal of this trial is to determine whether the less invasive FANS-assisted approach is non-inferior to mini-PCNL in terms of efficacy, while potentially offering advantages in postoperative recovery and safety.
Detailed description
The FLAME Trial (Flexible ureteroscopy for Lower pole stones And Mini-pErcutaneous nephrolithotomy) is an international, multicenter, prospective, randomized, controlled, non-inferiority study that aims to evaluate the safety and efficacy of flexible ureteroscopy assisted by a Flexible and Navigable Suction Ureteral Access Sheath (FANS) compared with mini-percutaneous nephrolithotomy (mini-PCNL) in the treatment of 1-2 cm lower pole renal stones.
This trial will enroll 640 patients from 20 urology centers with substantial experience in endoscopic stone surgery, including hospitals in China, Russia, Turkey, and India. Eligible participants will be randomly assigned in a 1:1 ratio to either the FANS-assisted flexible ureteroscopy group or the mini-PCNL group. All patients will undergo preoperative imaging, intraoperative standardization, and postoperative follow-up according to the study protocol.
The primary endpoint is the stone-free rate (SFR) within 72 hours postoperatively, evaluated by non-contrast-enhanced computed tomography (NCCT). Secondary endpoints include SFR at 1 month, operative time, length of hospital stay, postoperative pain (measured by VAS score), complication rates (graded by Clavien-Dindo classification), changes in renal function, and health-related quality of life (HRQoL).
The FANS, developed to improve irrigation control and active stone fragment suction during flexible ureteroscopy, may provide better visualization, reduce intrarenal pressure, and shorten operative time. By directly comparing FANS-assisted fURS with mini-PCNL, the trial seeks to determine whether a less invasive method can achieve comparable outcomes in terms of stone clearance and complication rates.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized in a 1:1 ratio to undergo either FANS-assisted flexible ureteroscopy or mini-percutaneous nephrolithotomy for the treatment of 1-2 cm lower pole renal stones. This is a multicenter, international, randomized, non-inferiority trial.
| Arm | Type | Receives |
|---|---|---|
| FANS-fURS Group | Experimental | Procedure: Flexible ureteroscopy with FANSPatients assigned to this group will undergo flexible ureteroscopy with FANS (Flexible endoscopy-Assisted Negative-pressure Suction Sheath). The FANS facilitates direct stone visualization, fragmentation, suction, and removal under controlled pressure conditions. |
| mini-PCNL Group | Active comparator | Procedure: Mini-percutaneous nephrolithotomy (mini-PCNL)Patients in this group will receive mini-percutaneous nephrolithotomy (mini-PCNL) via less than 20 Fr percutaneous tracts. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults aged 18-75 years;
- American Society of Anesthesiology (ASA) score 1-3;
- Lower pole renal stones-single or multiple-with a maximal diameter of 1-2 cm confirmed by CT;
- Ability to provide written informed consent and adhere to trial requirements.
Key exclusion criteria (10 listed)
- Significant urinary tract anatomical anomalies (e.g. horseshoe kidney, ileal conduit);
- Stones located within a calyceal diverticulum;
- History of open nephrolithotomy or ureterolithomy (due to resultant intrarenal anatomical distortion);
- Absolute contraindications to either FANS-f-URS or mini-PCNL, including:
- Inability to understand or complete trial documentation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Flexible ureteroscopy with FANSThe FANS with negative-pressure suction, enhancing intrarenal pressure control and fragment evacuation during flexible ureteroscopy. | Procedure or surgery | FANS-fURS Group |
| Mini-percutaneous nephrolithotomy (mini-PCNL)Mini-PCNL is performed under general anesthesia with less than 20 Fr access tract, using rigid nephroscopy and stone fragmentation under direct visualization. Postoperative drainage is provided via nephrostomy or ureteral stent as per protocol. | Procedure or surgery | mini-PCNL Group |
Primary outcome
Immediate Stone-Free Rate (SFR)
Time frame: 72 hours after surgery
Stone-free status will be evaluated using non-contrast-enhanced computed tomography (NCCT) performed within 72 hours after surgery. Stone-free is defined as the absence of residual stone fragments or presence of clinically insignificant fragments ≤2 mm.
6 secondary outcomes
Final Stone-Free Rate (SFR) at 1 Month
Time frame: 1 month after surgery
Operative Time
Time frame: Intraoperative
Postoperative Pain Level
Time frame: Within 24 hours after surgery.
Length of Hospital Stay
Time frame: From the day of surgery until the day of discharge, assessed up to 30 days postoperatively.
Complication Rate Within 1 Month
Time frame: 1 month after surgery.
Change in Quality of Life Score
Time frame: Baseline and 1 month after surgery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Background: PubMed 40268592Skolarikos A, Geraghty R, Somani B, Tailly T, Jung H, Neisius A, Petrik A, Kamphuis GM, Davis N, Bezuidenhout C, Lardas M, Gambaro G, Sayer JA, Lombardo R, Tzelves L. European Association of Urology Guidelines on the Diagnosis and Treatment of Urolithiasis. Eur Urol. 2025 Jul;88(1):64-75. doi: 10.1016/j.eururo.2025.03.011. Epub 2025 Apr 22.
- Derived from this study: PubMed 41323963Zhu W, Zhong J, Wang K, Yin G, Leung CH, Gadzhiev N, Gokce MI, Kalathia J, Gauhar V, Zhang G, Wu G, Li M, Fang L, Zeng S, Bai P, Li J, Zhao Z, Xi M, Mai X, Duan X, Jiang K, Cao J, Meng X, Liu S, Aloyan A, Yuan P, Zhu X, Huang T, Xing J, Du J, Wu W, Ma J, Zhong W, Zhao Z, Liu Y, Ng CF, de la Rosette J, Somani B, Qi S, Zeng G, Yuen SKK. Flexible ureteroscopy with a flexible and navigable suction ureteral access sheath versus mini-percutaneous nephrolithotomy for 1-2 cm lower pole renal stones: Protocol for an international, multicentre, randomized non-inferiority trial (FLAME trial). BJUI Compass. 2025 Nov 29;6(12):e70114. doi: 10.1002/bco2.70114. eCollection 2025 Dec.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared due to institutional policy restrictions and data privacy considerations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flexible ureteroscopy with FANS and Mini-percutaneous nephrolithotomy (mini-PCNL) in people with Kidney Stones, run by The First Affiliated Hospital of Guangzhou Medical University at 1 site in China.
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 4 inclusion and 10 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: finished, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immediate Stone-Free Rate (SFR) (time frame: 72 hours after surgery). 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 NCT07159035, which also lists 2 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 7 Jul 2026.