Steerable vs Conventional FANS for <2cm Lower Pole Stone Treatment: SCULPT Trial

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.

Conditions

• Kidney Stones

Interventions

DEVICE

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.

DEVICE

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.

Sponsors & Collaborators

• the third Medical Center, PLA General Hospital

  collaborator UNKNOWN

• First Affiliated Hospital of Chongqing Medical University

  collaborator OTHER

• Peking University People's Hospital

  collaborator OTHER

• The Second Affiliated Hospital of Kunming Medical University

  collaborator OTHER

• The Fifth Affiliated Hospital, Sun Yat-sen University

  collaborator UNKNOWN

• Henan Provincial People's Hospital

  collaborator OTHER

• Nanfang Hospital, Southern Medical University

  collaborator OTHER

• Wuhan Hospital of Traditional Chinese Medicine

  collaborator OTHER

• Dongguan People's Hospital

  collaborator OTHER_GOV

• Changzhou No.2 People's Hospital

  collaborator OTHER

• Dongguan Tungwah Hospital

  collaborator OTHER

• Panzhihua Central Hospital

  collaborator OTHER

• Yan'an Hospital of Kunming City

  collaborator UNKNOWN

• NO.1 People's Hospital of Dali City

  collaborator UNKNOWN

• Huadu District People's Hospital of Guangzhou

  collaborator OTHER

• Jiangmen Central Hospital

  collaborator OTHER

• Shaoyang Central Hospital

  collaborator UNKNOWN

• Guangzhou Medical University Affiliated Qingyuan Hospital

  collaborator UNKNOWN

• Dongguan Kanghua Hospital

  collaborator OTHER

• The First Affiliated Hospital of Guangzhou Medical University

  lead OTHER

Principal Investigators

• Guohua Zeng, M.D. · The First Affiliated Hospital of Guangzhou Medical University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-03-16

Primary Completion

2026-01-01

Completion

2026-03-01

Countries

• China

Study Locations