NCT06898216

Brief 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.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 16, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

March 16, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 27, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

March 27, 2025

Status Verified

March 1, 2025

Enrollment Period

10 months

First QC Date

March 16, 2025

Last Update Submit

March 20, 2025

Conditions

Kidney Stones

Keywords

flexible ureteroscopyflexible and navigable suction ureteral access sheathFANSlower polerenal stones

Outcome Measures

Primary Outcomes (1)

  • Success Rate of Lower Pole Navigation

    This outcome is defined as the proportion of cases in which the FANS (either steerable or conventional) successfully navigates into the lower pole renal calyx. Success is evidenced by the ability to directly visualize the stone, perform effective laser lithotripsy, and aspirate stone fragments without requiring additional adjunctive devices.

    Periprocedural (Day of Procedure)

Secondary Outcomes (8)

  • Immediate Stone-Free Rate

    Day 1

  • Final Stone-Free Rate

    1 month

  • Operative Time

    Periprocedural (Day of Procedure)

  • Duration of Hospital Stay

    Periprocedural (Day of Procedure through Discharge)

  • Use of Adjunct Devices

    Recorded during the procedure

  • +3 more secondary outcomes

Study Arms (2)

Steerable FANS Arm

EXPERIMENTAL

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.

Device: Steerable FANS

Conventional FANS Arm

ACTIVE COMPARATOR

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.

Device: Conventional FANS

Interventions

Steerable FANSDEVICE

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.

Also known as: Steerable Flexible and Navigable Suction Ureteral Access Sheath
Steerable FANS Arm
Conventional FANSDEVICE

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.

Also known as: Conventional Flexible and Navigable Suction Ureteral Access Sheath
Conventional FANS Arm

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Guangzhou, Guangdong, 510230, China

RECRUITING

Related Publications (1)

  • Yuen SKK Steffi, Liu S, Gauhar V, Mai H, He W, Hu H, Ke C, Dai Y, Shan L, Jiang Y, Yuan J, Cao Z, Zuo L, Yang C, Bai B, Bi X, Zhao H, Xi M, Ding N, Deng S, Tang S, Zeng J, Du J, Wu W, Ma J, Zhong W, Zhao Z, Liu Y, de la Rosette J, Zeng G, Zhu W. Steerable versus Conventional flexible and navigable suction ureteral access sheath (FANS) flexible Ureteroscopy for Lower Pole stones Treatment: study protocol for a multicentre, randomised superiority trial (SCULPT trial). BMJ Open. 2025 Dec 2;15(12):e103866. doi: 10.1136/bmjopen-2025-103866.

    PMID: 41338650DERIVED

MeSH Terms

Conditions

Kidney CalculiNephrolithiasis

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrolithiasisUrinary CalculiMale Urogenital DiseasesCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Guohua Zeng, M.D.

    The First Affiliated Hospital of Guangzhou Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Guohua Zeng, M.D.

CONTACT

13622754991gzgyzgh@vip.sina.com

Steffi Yuen, M.D.

CONTACT

Steffiyuen@surgery.cuhk.edu.hk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice president

Study Record Dates

First Submitted

March 16, 2025

First Posted

March 27, 2025

Study Start

March 16, 2025

Primary Completion

January 1, 2026

Study Completion

March 1, 2026

Last Updated

March 27, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)