NCT07840482

Brief Summary

Kidney stones are commonly treated with flexible ureteroscopy, a minimally invasive procedure in which a small scope is passed through the urinary tract to reach and treat stones in the kidney. Flexible and navigable suction access sheaths (FANS), such as the ClearPetra™ system, allow irrigation and suction to be used during the procedure to help remove stone fragments. The purpose of this randomized study is to compare two different irrigation and suction pressure settings used with the ClearPetra™ FANS system during flexible ureteroscopy. Approximately 100 adults undergoing ureteroscopy for kidney stones will be randomly assigned to either a higher-flow setting or a moderate-flow setting. The study will compare stone clearance, operative characteristics, and postoperative outcomes to determine which setting provides the most effective and safe treatment conditions.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
37mo left

Started Nov 2026

Typical duration for not_applicable

Status
not yet 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

September 18, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 25, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2026

Expected
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2029

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2029

Last Updated

September 30, 2026

Status Verified

September 1, 2026

Enrollment Period

3 years

First QC Date

September 18, 2026

Last Update Submit

September 25, 2026

Conditions

Stone, Kidney

Keywords

StoneFANSSuction sheathureteroscopyirrigation settings

Outcome Measures

Primary Outcomes (1)

  • Stone-Free Rate (SFR)

    Stone-free status will be assessed using postoperative imaging. Stone free is defined as no residual stone fragments greater than 2 mm visible on imaging. The proportion of participants meeting this definition will be compared between the two study arms.

    Approximately 3 months postoperatively

Study Arms (2)

High-Flow FANS Setting

EXPERIMENTAL

Participants will undergo retrograde intrarenal surgery (RIRS) using the ClearPetra™ vacuum-assisted ureteral access sheath with irrigation pressure of 250 mmHg using an automated irrigation pump and suction pressure of 200 mmHg.

Device: ClearPetra™ FANS - High-Flow Setting

Moderate-Flow FANS Setting

ACTIVE COMPARATOR

Participants will undergo retrograde intrarenal surgery (RIRS) using the ClearPetra™ vacuum-assisted ureteral access sheath with irrigation pressure of 150 mmHg using an automated irrigation pump and suction pressure of 120 mmHg.

Device: ClearPetra™ FANS - Moderate-Flow Setting

Interventions

ClearPetra™ FANS - High-Flow SettingDEVICE

ClearPetra™ 11/13 Fr Flexible and Navigable Suction Access Sheath (FANS) used during retrograde intrarenal surgery with irrigation pressure of 250 mmHg using an automated irrigation pump and suction pressure of 200 mmHg.

High-Flow FANS Setting
ClearPetra™ FANS - Moderate-Flow SettingDEVICE

ClearPetra™ 11/13 Fr Flexible and Navigable Suction Access Sheath (FANS) used during retrograde intrarenal surgery with irrigation pressure of 150 mmHg using an automated irrigation pump and suction pressure of 120 mmHg.

Moderate-Flow FANS Setting

Eligibility Criteria

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

You may qualify if:

  • Male or female participants aged 18 years or older.
  • Undergoing flexible ureteroscopy for retrograde intrarenal surgery.
  • Total stone burden between 1.0 and 2.5 cm.

You may not qualify if:

  • Undergoing bilateral stone treatment during the same procedure.
  • Known genitourinary anatomical abnormalities.
  • Uncorrected coagulopathy.
  • Urinary diversion.
  • Chronic external urinary catheter.
  • Pregnancy.
  • Immunosuppression.
  • Participation in another clinical research study during the duration of this trial, unless the investigator determines on a case-by-case basis that participation in the other study will not adversely affect the outcomes or integrity of this trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • Chen Y, Zheng L, Lin L, Li C, Gao L, Ke L, Kuang R, Chen J. A novel flexible vacuum-assisted ureteric access sheath in retrograde intrarenal surgery. BJU Int. 2022 Nov;130(5):586-588. doi: 10.1111/bju.15873. Epub 2022 Sep 6. No abstract available.

    PMID: 35986898BACKGROUND

  • Brain E, Geraghty RM, Lovegrove CE, Yang B, Somani BK. Natural History of Post-Treatment Kidney Stone Fragments: A Systematic Review and Meta-Analysis. J Urol. 2021 Sep;206(3):526-538. doi: 10.1097/JU.0000000000001836. Epub 2021 Apr 27.

    PMID: 33904756BACKGROUND

  • Ghani KR, Wolf JS Jr. What is the stone-free rate following flexible ureteroscopy for kidney stones? Nat Rev Urol. 2015 May;12(5):281-8. doi: 10.1038/nrurol.2015.74. Epub 2015 Apr 14.

    PMID: 25868563BACKGROUND

  • Tonyali S. Suctioning ureteral access sheath use in flexible ureteroscopy might decrease operation time and prevent infectious complications. World J Urol. 2019 Feb;37(2):393-394. doi: 10.1007/s00345-018-2510-5. Epub 2018 Sep 26. No abstract available.

    PMID: 30259124BACKGROUND

  • Assimos D, Krambeck A, Miller NL, Monga M, Murad MH, Nelson CP, Pace KT, Pais VM Jr, Pearle MS, Preminger GM, Razvi H, Shah O, Matlaga BR. Surgical Management of Stones: American Urological Association/Endourological Society Guideline, PART I. J Urol. 2016 Oct;196(4):1153-60. doi: 10.1016/j.juro.2016.05.090. Epub 2016 May 27.

    PMID: 27238616BACKGROUND

MeSH Terms

Conditions

Kidney CalculiCalculi

Condition Hierarchy (Ancestors)

NephrolithiasisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrolithiasisUrinary CalculiMale Urogenital DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Wilson Molina, md

    University of Kansas Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Wilson Molina, Md

CONTACT

913-588-6146wmolina@kumc.edu

Bristol B. Whiles, md

CONTACT

bwhiles@kumc.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 18, 2026

First Posted

September 25, 2026

Study Start (Estimated)

November 1, 2026

Primary Completion (Estimated)

November 1, 2029

Study Completion (Estimated)

November 1, 2029

Last Updated

September 30, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will share

De-identified individual participant data collected during the study might be shared after study completion for other research purpose. These data may include participant demographics, medical history, stone characteristics, operative and procedural data, postoperative outcomes and complications, stone-free status, and follow-up information regarding subsequent stone events, imaging, and additional treatments or reinterventions. No personally identifiable information will be shared.