An interventional study of ClearPetra™ FANS - High-Flow Setting and ClearPetra™ FANS - Moderate-Flow Setting in Stone, Kidney, sponsored by University of Kansas Medical Center. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-30.
Sponsored by University of Kansas Medical Center · Not applicable, Interventional, and Treatment
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.
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.
509 studies on the registry are indexed under Kidney Calculi; 146 are open to participants now.
This study's planned enrollment of 100 is above the median of 86 across 391 interventional studies indexed under Kidney Calculi.
Browse Kidney Calculi studies →University of Kansas Medical Center is the lead sponsor of 492 studies on the registry; 110 are open to participants now.
Of its 38 completed or terminated interventional studies of FDA-regulated products, 24 (63%) have results posted.
Counted across the registry records on this site, refreshed daily.
The criteria were revised on the registry on Sep 30, 2026. See what changed
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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™ 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.
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.
Time frame: Approximately 3 months postoperatively
No study locations are listed for this record.
Plan to share: 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.
Start is estimated for Nov 2026; primary completion for Nov 2029, 36 months later.
Of 183 non-industry interventional studies with no phase under Kidney Calculi, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 54. This study's planned 36 months is above that.
Counting every sponsor, half of 199 studies reached it within 26 months; a quarter within 12 and three quarters within 51.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Kansas Medical Center →