Stone, KidneyNCT07840482
FANS-Optimization of Irrigation and Suction Parameters in RIRS
A study testing ClearPetra™ FANS - High-Flow Setting and ClearPetra™ FANS - Moderate-Flow Setting in people with Stone, Kidney, run by University of Kansas Medical Center.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stone, Kidney
- What is being tested?
- ClearPetra™ FANS - High-Flow Setting and ClearPetra™ FANS - Moderate-Flow Setting
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2026to 1 Nov 2029
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Bristol B. Whiles, md contact
About this study
Official title: ClearPetra™ Vacuum-Assisted Ureteral Access Sheath Optimization of Irrigation and Suction Parameters in FANS-Assisted Flexible Ureteroscopy: A Randomized Controlled Trial
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.
Read the detailed description
This is a prospective, single-center, single-blinded, randomized controlled trial evaluating two predefined irrigation and suction pressure configurations using the ClearPetra™ 11/13 Fr Flexible and Navigable Suction Access Sheath (FANS) during retrograde intrarenal surgery (RIRS).
Approximately 100 adult patients undergoing flexible ureteroscopy for treatment of kidney stones with a total stone burden of 1.0 to 2.5 cm will be enrolled. Participants will be randomized in a 1:1 ratio to one of two treatment groups. The high-flow group will undergo RIRS using irrigation at 250 mmHg with an automated irrigation pump and suction at 200 mmHg. The moderate-flow group will undergo RIRS using irrigation at 150 mmHg and suction at 120 mmHg.
The primary objective is to evaluate the effect of these irrigation and suction settings on procedural and postoperative outcomes. The primary outcome is stone-free status assessed by postoperative computed tomography approximately three months after surgery. Stone-free status is defined in the protocol as no residual stone fragments greater than 2 mm.
Secondary outcomes include basket use, total operative time, laser time, total laser energy, and postoperative infection within 30 days. Additional exploratory assessments will evaluate the ability of the FANS sheath to reach the upper and lower pole calyces, sheath length selection, intraoperative deflection characteristics, and the amount of sheath remaining outside the patient during upper-pole access.
Participants will undergo clinical care and follow-up according to standard practice. Follow-up information will be collected approximately three months after surgery, and long-term follow-up will continue for up to 12 months to assess subsequent stone events, additional treatments or reinterventions, and available stone-related imaging.
- Conditions
- Stone, Kidney
- Being tested
- ClearPetra™ FANS - High-Flow Setting, ClearPetra™ FANS - Moderate-Flow Setting
- Keywords
- Stone, FANS, Suction sheath, ureteroscopy, irrigation settings
- Medical subject headings
- Kidney Calculi, Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: ClearPetra™ FANS - Moderate-Flow Setting |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Approximately 3 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Nov 2029 (estimated)
- Study completion1 Nov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Stone, KidneyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- KARL STORZ Endoscopy-America, Inc.
- Responsible party
- Sponsor
- Investigators
- Wilson Molina, md, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07840482
- Sponsor's protocol ID
- IIT-FANS
- Status last verified
- Sep 2026
- First submitted
- 18 Sep 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 35986898Brain 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.
PubMed 33904756Ghani 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.
PubMed 25868563Tonyali 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.
PubMed 30259124Assimos 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.
PubMed 27238616