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)

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This multicenter, randomized, controlled superiority trial (the SCULPT trial) aims to compare the efficacy and safety of a novel steerable flexible and navigable suction ureteral access sheath (FANS) versus the conventional FANS in the treatment of lower pole renal stones ≤2 cm. Lower pole stones are particularly challenging due to the narrow infundibular-pelvic anatomy that limits the maneuverability of standard FANS. The steerable FANS incorporates an active deflection mechanism that allows for independent control, potentially improving the success rate of accessing the lower pole calyx, performing laser lithotripsy, and aspirating stone fragments without additional adjuncts. 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Adults aged 18-75 years

• 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

Locations
Other Locations
China
Department of Urology, The First Affiliated Hospital of Guangzhou Medical University
RECRUITING
Guangzhou
Contact Information
Primary
Guohua Zeng, M.D.
gzgyzgh@vip.sina.com
13622754991
Backup
Steffi Yuen, M.D.
Steffiyuen@surgery.cuhk.edu.hk
Time Frame
Start Date: 2025-03-16
Estimated Completion Date: 2026-03-01
Participants
Target number of participants: 400
Treatments
Experimental: 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.
Active_comparator: 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.
Sponsors
Collaborators: Yan'an Hospital of Kunming City, Jiangmen Central Hospital, the third Medical Center, PLA General Hospital, Changzhou No.2 People's Hospital, Huadu District People's Hospital of Guangzhou, The Fifth Affiliated Hospital, Sun Yat-sen University, Guangzhou Medical University Affiliated Qingyuan Hospital, Panzhihua Central Hospital, NO.1 People's Hospital of Dali City, Shaoyang Central Hospital, Peking University People's Hospital, The First Affiliated Hospital of Chongqing Medical University,China, Nanfang Hospital, Southern Medical University, Dongguan Tungwah Hospital, Henan Provincial People's Hospital, The Second Affiliated Hospital of Kunming Medical University, Wuhan Hospital of Traditional Chinese Medicine, Dongguan Kanghua Hospital, Dongguan People's Hospital
Leads: The First Affiliated Hospital of Guangzhou Medical University

This content was sourced from clinicaltrials.gov