Steerable vs Conventional FANS for <2cm Lower Pole Stone Treatment: SCULPT Trial
Launched by THE FIRST AFFILIATED HOSPITAL OF GUANGZHOU MEDICAL UNIVERSITY · Mar 20, 2025
Trial Information
Current as of July 24, 2025
Recruiting
Keywords
ClinConnect Summary
The SCULPT trial is a study comparing two types of tools used to treat kidney stones located in the lower part of the kidney, specifically stones that are 2 centimeters or smaller. Researchers want to see if a new steerable tool, which can be controlled more easily, is better than the standard tool at successfully reaching and treating these stones. This new tool may help doctors remove stones more effectively and safely. The trial will involve 400 adults from various hospitals in China, and participants will be randomly assigned to receive either the steerable tool or the conventional one during a procedure called flexible ureteroscopy, where a small camera and instruments are used to treat kidney stones.
To be eligible for this trial, participants need to be between 18 and 75 years old and have a single lower pole kidney stone that is 2 centimeters or smaller. They also need to be in good health overall, as assessed by a doctor. During the trial, participants can expect to undergo the procedure and will be monitored for their recovery, including how well the treatment works and any potential complications. This study aims to provide important information that could improve how kidney stones are treated in the future.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 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
- Exclusion Criteria:
- • Patients with urinary tract anatomical abnormalities (e.g., horseshoe kidney, ileal conduit)
- • 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
About The First Affiliated Hospital Of Guangzhou Medical University
The First Affiliated Hospital of Guangzhou Medical University is a leading clinical research institution located in Guangzhou, China, renowned for its commitment to advancing medical knowledge and improving patient care through innovative research. As a comprehensive teaching hospital, it integrates clinical practice, education, and research, fostering a multidisciplinary approach to healthcare. The hospital is equipped with state-of-the-art facilities and a team of experienced professionals dedicated to conducting high-quality clinical trials across various therapeutic areas. By leveraging its extensive expertise and resources, the First Affiliated Hospital aims to contribute significantly to the development of new treatments and therapies, enhancing health outcomes for patients both locally and globally.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Guangzhou, Guangdong, China
Patients applied
Trial Officials
Guohua Zeng, M.D.
Principal Investigator
The First Affiliated Hospital of Guangzhou Medical University
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported