Steerable vs Conventional FANS for <2cm Lower Pole Stone Treatment: SCULPT Trial
NCT ID: NCT06898216
Last Updated: 2025-03-27
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
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RECRUITING
NA
400 participants
INTERVENTIONAL
2025-03-16
2026-03-01
Brief Summary
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A total of 400 patients from 20 high-volume urological centers in China (approximately 20 patients per center) will be randomized in a 1:1 ratio to receive either steerable FANS or conventional FANS during flexible ureteroscopy. Primary outcome measures include the success rate of FANS navigation into the lower pole calyx as evidenced by direct stone visualization, effective laser lithotripsy, and successful stone aspiration. Secondary outcomes will assess immediate and 1-month stone-free rates, operative time, complication rates, instrument durability, and improvements in quality of life. This study is expected to provide critical evidence to guide clinical decision-making and potentially improve treatment efficiency for challenging lower pole renal stones.
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Detailed Description
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Background and Objectives Lower pole stones are notoriously difficult to treat due to their anatomical position and the limited maneuverability of conventional ureteral access sheaths. The new steerable FANS, with its deflection lever at the distal handle, allows for active, independent adjustment under endoscopic guidance, which may result in a higher success rate of reaching the lower pole and more efficient stone clearance. The primary objective of this trial is to compare the success rate of FANS navigation into the lower pole renal calyx between the steerable and conventional devices. Secondary objectives include the evaluation of immediate (within 24 hours) and 1-month stone-free rates, operative time, length of hospital stay, usage of auxiliary devices (e.g., stone baskets), instrument damage rates, complication rates (graded by the Clavien-Dindo system), and the impact on patient quality of life (assessed via the Wisconsin Stone QoL questionnaire).
Study Design and Methods
Trial Type:
This is a multicenter, prospective, single-blind, superiority, randomized controlled trial.
Study Setting and Participants:
The study will be conducted at 20 high-volume urological centers across China, with each center recruiting approximately 20 patients. Eligible participants are adults aged 18-75 years, diagnosed with a single lower pole renal stone ≤2 cm (confirmed by CT) and who meet all inclusion and exclusion criteria.
Randomization and Group Allocation:
A centralized, stratified randomization process (1:1 ratio) will allocate patients to either the steerable FANS or conventional FANS group. Random sequences will be generated electronically using permuted blocks within each center to maintain allocation concealment.
Interventions:
All patients will undergo flexible ureteroscopy under general anesthesia with standardized use of 7.5 Fr digital flexible ureteroscopes. Preoperative imaging (contrast-enhanced CT urography) will assess stone size, location, and anatomical parameters. Depending on ureteral diameter, an appropriate FANS (either 11/13 Fr or a smaller version) will be selected. Laser lithotripsy will be performed using a 200 µm laser fiber (energy settings ≤30 W) alongside continuous negative-pressure suction to aspirate stone fragments. If the sheath cannot be navigated into the lower pole due to anatomical constraints, an adjunct stone basket may be employed.
Outcome Measures:
Primary Outcome:
The success rate of FANS navigation into the lower pole calyx, defined as the sheath reaching the calyx, performing effective laser lithotripsy, and aspirating stone fragments without additional adjuncts.
Secondary Outcomes:
These include the immediate (24-hour) and final (1-month) stone-free rates (defined as no residual stone or fragments \>2 mm on CT), operative time, duration of hospital stay, intraoperative usage of adjunct devices, damage rates of the ureteroscope and FANS, complications within one month (graded by Clavien-Dindo), and quality of life improvements as measured by the Wisconsin Stone QoL questionnaire.
Follow-up and Data Collection:
Patients will undergo a low-dose CT scan within 24 hours postoperatively to assess the immediate stone-free status, with a follow-up CT at 1 month for final assessment. Clinical data, including operative details and follow-up results, will be recorded in standardized case report forms (CRFs) at each center. This will ensure consistency and completeness of data across the multicenter trial.
Sample Size and Statistical Analysis:
Based on preliminary data showing a 60% success rate with conventional FANS and an anticipated 80% with the steerable FANS, with a superiority margin of 6%, a total of 400 participants (200 per group) has been calculated to achieve 80% power at a one-sided α of 2.5%, accounting for potential dropouts. Statistical analyses will be conducted using SPSS software, with continuous variables analyzed via t-tests or Mann-Whitney U tests (depending on data distribution) and categorical variables assessed using chi-square or Fisher's exact tests. Multivariate analyses will be performed where necessary, and results will be presented with 95% confidence intervals.
Quality Control and Safety Monitoring:
All participating centers will undergo standardized training to ensure uniformity in surgical procedures and data collection. Monthly monitoring visits will verify protocol adherence and data integrity. Any adverse events will be meticulously recorded and reported promptly to the Ethics Committee, with regular cumulative safety reviews performed by the principal investigator.
Significance and Expected Outcomes This trial is the first head-to-head comparison of steerable versus conventional FANS in the management of lower pole renal stones. If the steerable FANS demonstrates superiority in navigating the lower pole and enhancing stone clearance efficiency, it could transform the current endourological approach to challenging renal calculi. In addition, the comprehensive evaluation of instrument durability and complication profiles will aid in economic assessments and inform patient counseling regarding procedural risks and benefits. Ultimately, the findings of this study are expected to contribute robust evidence toward optimizing clinical strategies, improving patient outcomes, and potentially expanding the indications for flexible ureteroscopy in complex renal stone management.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Steerable FANS Arm
Participants assigned to this arm will undergo flexible ureteroscopy using the novel steerable flexible and navigable suction ureteral access sheath (FANS). This device incorporates an active deflection mechanism that allows for independent adjustment to optimize navigation into the lower pole calyx. The procedure is performed under general anesthesia with a standardized 7.5 Fr digital flexible ureteroscope, using a 200 µm holmium laser (energy settings ≤30 W) for lithotripsy, and continuous negative-pressure suction for stone fragment aspiration. Adjunct devices (e.g., stone baskets) may be utilized if necessary.
Steerable FANS
This device is designed for flexible ureteroscopy procedures in patients with lower pole renal stones ≤2 cm. It features an active deflection mechanism that enables independent adjustment to enhance access into the lower pole calyx. The description focuses solely on the device and does not include procedural details already provided in the arm description.
Conventional FANS Arm
Participants assigned to this arm will receive flexible ureteroscopy using the conventional flexible and navigable suction ureteral access sheath (FANS), which relies on passive deflection provided by the ureteroscope for navigation into the lower pole calyx. The procedure is conducted under general anesthesia with a 7.5 Fr digital flexible ureteroscope, employing a 200 µm holmium laser (energy settings ≤30 W) for lithotripsy and continuous negative-pressure suction for fragment removal. Adjunctive retrieval tools (e.g., stone baskets) may be used as required.
Conventional FANS
This device is intended for use in flexible ureteroscopy for lower pole renal stone management. It relies on passive deflection provided by the flexible ureteroscope for navigation into the lower pole calyx. The description is limited to the device characteristics without duplicating procedural details from the arm description.
Interventions
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Steerable FANS
This device is designed for flexible ureteroscopy procedures in patients with lower pole renal stones ≤2 cm. It features an active deflection mechanism that enables independent adjustment to enhance access into the lower pole calyx. The description focuses solely on the device and does not include procedural details already provided in the arm description.
Conventional FANS
This device is intended for use in flexible ureteroscopy for lower pole renal stone management. It relies on passive deflection provided by the flexible ureteroscope for navigation into the lower pole calyx. The description is limited to the device characteristics without duplicating procedural details from the arm description.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosed with a single lower pole renal stone ≤2 cm by CT
* American Society of Anesthesiology (ASA) score of 1-3
* Ability to provide written informed consent
* Willingness and ability to comply with trial procedures and follow-up
Exclusion Criteria
* Untreated urinary tract infection
* Presence of multiple stones or stones located outside the lower pole
* Absolute contraindications to flexible ureteroscopy
* Inability to understand or complete trial documentation
18 Years
75 Years
ALL
No
Sponsors
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the third Medical Center, PLA General Hospital
UNKNOWN
First Affiliated Hospital of Chongqing Medical University
OTHER
Peking University People's Hospital
OTHER
The Second Affiliated Hospital of Kunming Medical University
OTHER
The Fifth Affiliated Hospital, Sun Yat-sen University
UNKNOWN
Henan Provincial People's Hospital
OTHER
Nanfang Hospital, Southern Medical University
OTHER
Wuhan Hospital of Traditional Chinese Medicine
OTHER
Dongguan People's Hospital
OTHER_GOV
Changzhou No.2 People's Hospital
OTHER
Dongguan Tungwah Hospital
OTHER
Panzhihua Central Hospital
OTHER
Yan'an Hospital of Kunming City
UNKNOWN
NO.1 People's Hospital of Dali City
UNKNOWN
Huadu District People's Hospital of Guangzhou
OTHER
Jiangmen Central Hospital
OTHER
Shaoyang Central Hospital
UNKNOWN
Guangzhou Medical University Affiliated Qingyuan Hospital
UNKNOWN
Dongguan Kanghua Hospital
OTHER
The First Affiliated Hospital of Guangzhou Medical University
OTHER
Responsible Party
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Guohua Zeng
Vice president
Principal Investigators
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Guohua Zeng, M.D.
Role: PRINCIPAL_INVESTIGATOR
The First Affiliated Hospital of Guangzhou Medical University
Locations
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Department of Urology, The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ES-2025-033
Identifier Type: -
Identifier Source: org_study_id
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