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

NARecruitingINTERVENTIONAL
Enrollment

400

Participants

Timeline

Start Date

March 16, 2025

Primary Completion Date

January 1, 2026

Study Completion Date

March 1, 2026

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.

Trial Locations (1)

510230

RECRUITING

Department of Urology, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou

All Listed Sponsors
collaborator

the third Medical Center, PLA General Hospital

UNKNOWN

collaborator

The First Affiliated Hospital of Chongqing Medical University,China

UNKNOWN

collaborator

Peking University People's Hospital

OTHER

collaborator

The Second Affiliated Hospital of Kunming Medical University

OTHER

collaborator

The Fifth Affiliated Hospital, Sun Yat-sen University

UNKNOWN

collaborator

Henan Provincial People's Hospital

OTHER

collaborator

Nanfang Hospital, Southern Medical University

OTHER

collaborator

Wuhan Hospital of Traditional Chinese Medicine

OTHER

collaborator

Dongguan People's Hospital

OTHER_GOV

collaborator

Changzhou No.2 People's Hospital

OTHER

collaborator

Dongguan Tungwah Hospital

OTHER

collaborator

Panzhihua Central Hospital

OTHER

collaborator

Yan'an Hospital of Kunming City

UNKNOWN

collaborator

NO.1 People's Hospital of Dali City

UNKNOWN

collaborator

Huadu District People's Hospital of Guangzhou

OTHER

collaborator

Jiangmen Central Hospital

OTHER

collaborator

Shaoyang Central Hospital

UNKNOWN

collaborator

Guangzhou Medical University Affiliated Qingyuan Hospital

UNKNOWN

collaborator

Dongguan Kanghua Hospital

OTHER

lead

The First Affiliated Hospital of Guangzhou Medical University

OTHER