Evidence map›Paper›PMID 41338650›Full record

ArticleBMJ open2025

Steerable versus Conventional flexible and navigable suction ureteral access sheath (FANS) flexible Ureteroscopy for Lower Pole stones Treatment: study protocol for a multicentre, randomised superiority trial (SCULPT trial).

Steffi Kar Kei Yuen, Shusheng Liu, Vineet Gauhar, Haixing Mai, Weiyang He, Hao Hu, Changxing Ke, Yinbo Dai, Lei Shan, Yaodong Jiang and 21 more

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06898216 (Flexible Ureteroscopy With Steerable Versus Conventional Flexible and Navigable Suction Ureteral Access Sheath), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06898216 narecruitingnot on this map

Flexible Ureteroscopy With Steerable Versus Conventional Flexible and Navigable Suction Ureteral Access Sheath (FANS) Utility in Less Than 2cm Lower Pole Stones Treatment: a Multicenter, Randomized Superiority Trial (SCULPT Trial)

TypeinterventionalSponsorThe First Affiliated Hospital of Guangzhou Medical UniversityRan2025 to 2026Enrolled400ConditionsKidney StonesArmsSteerable FANS, Conventional FANS
3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Trial
  2. Article
  3. Article
  4. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

31 authors.

Steffi Kar Kei Yuen *Department of Surgery, SH Ho Urology Centre, The Chinese University of Hong Kong, Hong Kong, China.
Shusheng Liu *Department of Urology, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.
Vineet Gauhar *Department of Urology, Ng Teng Fong General Hospital, Singapore.
Haixing Mai *Department of Urology, the third Medical Center, PLA General Hospital, Beijing, China.
Weiyang He *Department of Urology, The First Affiliated Hospital of Chongqing Medical University, Chongqing, China.
Hao Hu *Department of Urology, Peking University People's Hospital, Beijing, China.ORCID http://orcid.org/0000-0002-8569-9679
Changxing Ke *Department of Urology, The Second Affiliated Hospital of Kunming Medical University, Kunming, China.
Yinbo Dai *Department of Urology, The Fifth Affiliated Hospital, Sun Yat-sen University, Zhuhai, China.
Lei Shan *Department of Urology, Henan Provincial People's Hospital, Zhengzhou, China.
Yaodong Jiang *Department of Urology, Nanfang Hospital, Southern Medical University, Guangzhou, China.
Jingdong Yuan *Department of Urology, Wuhan NO.1 Hospital, Wuhan, China.
Zhengguo Cao *Department of Urology, The Tenth Affiliated Hospital, Southern Medical University (Dongguan People's Hospital), Dongguan, China.
Li Zuo *Department of Urology, Changzhou No.2 People's Hospital, Changzhou, Jiangsu, China.
Chunting Yang *Department of Urology, Dongguan Tungwah Hospital, Dongguan, China.
Bing Bai *Department of Urology, Panzhihua Central Hospital, Panzhihua, China.
Xiaofang Bi *Department of Urology, Yan'an Hospital of Kunming City, Kunming, China.
Hengtai Zhao *Department of Urology, NO.1 People's Hospital of Dali City, Dali, China.
Ming Xi *Department of Urology, Huadu District People's Hospital of Guangzhou, Guangzhou, China.
Ning Ding *Department of Urology, Dongguan Kanghua Hospital, Dongguan, China.
Shuo Deng *Department of Urology, Jiangmen Central Hospital, Jiangmen, China.
Shan Tang *Department of Urology, Shaoyang Central Hospital, Shaoyang, China.
Jianwen Zeng *Department of Urology, the Affiliated Qingyuan Hospital (Qingyuan People's Hospital), Guangzhou Medical University, Qingyuan, China.
Jingzeng Du *Department of Urology, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.
Wenqi WuDepartment of Urology, The Second Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.
Jinxiang MaSchool of Public Health, Guangzhou Medical University, Guangzhou, China.
Wen ZhongDepartment of Urology, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.
Zhijian ZhaoDepartment of Urology, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.
Yongda LiuDepartment of Urology, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.
Jean de la RosetteInternational School of Medicine, Istanbul Medipol University, Istanbul, Turkey.
Guohua ZengDepartment of Urology, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China doczw1989@gzhmu.edu.cn gzgyzgh@vip.sina.com.
Wei ZhuDepartment of Urology, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China doczw1989@gzhmu.edu.cn gzgyzgh@vip.sina.com.ORCID http://orcid.org/0000-0002-4184-1223

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionFlexible ureteroscopy has advanced modern stone management; however, lower pole renal stones remain a challenge due to suboptimal ureteroscope deflection and navigation using conventional flexible and navigable suction ureteral access sheaths (FANS). The SCULPT trial is designed to assess whether the novel steerable FANS-which enables active controlled deflection-can improve the success rate of lower pole access during flexible ureteroscopy. METHODS AND ANALYSIS: This multicentre, prospective, single-blinded, randomised controlled superiority trial will recruit 400 adult patients (aged 18-75 years) with solitary lower pole renal stones ≤2 cm diagnosed by CT from 20 high-volume urological centres in China. Participants will be randomised 1:1 to undergo flexible ureteroscopy with either steerable or conventional FANS. The primary outcome is the success rate of navigating into the lower pole calyx (defined as successful direct stone visualisation, laser lithotripsy and aspiration without adjunct use). Secondary outcomes include immediate and 1 month stone-free rates, operative time, complication profiles (graded by Clavien-Dindo), instrument damage rates, quality-of-life assessments and cost analysis. Statistical analysis will be performed using appropriate tests for continuous and categorical data, with their significance set by prespecified superiority margins. ETHICS AND DISSEMINATION: The study protocol has been designed in accordance with the Declaration of Helsinki and ICH-GCP guidelines. Ethical approval was centrally granted by the Institutional Review Board of The First Affiliated Hospital of Guangzhou Medical University and adopted by all participating centres following local feasibility review. The trial results will be disseminated via peer-reviewed publication and presentation at international conferences. TRIAL REGISTRATION NUMBER: NCT06898216.

Indexed as

Kidney CalculiUreteroscopesUreteroscopyAdolescentAdultAgedChinaEquivalence Trials as TopicFemaleHumansMaleMiddle AgedMulticenter Studies as TopicProspective StudiesRandomized Controlled Trials as TopicSingle-Blind MethodClinical TrialMedicineUrolithiasis

Identifiers

PMID41338650
PMCPMC12673546

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.