Ho:YAG versus thulium fiber laser for mini-PCNL with the ClearPetra suction sheath
Holmium:YAG Laser With MOSES Technology vs Thulium Fiber Laser in Supine Mini-percutaneous Nephrolithotomy With Vacuum-assisted Renal Access Sheath: A Prospective, Randomized Clinical Trial
This trial will see if the Ho:YAG or thulium fiber laser clears kidney stones better during mini-PCNL with the ClearPetra suction sheath in adults with stones larger than 15 mm.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Kansas Medical Center Academic / other |
| Locations | 1 site (Kansas City, Kansas) |
| Trial ID | NCT07087977 on ClinicalTrials.gov |
What this trial studies
Mini‑PCNL uses a reduced‑diameter sheath and depends on laser fragmentation to clear stones; Ho:YAG has been the long‑standing standard while thulium fiber laser (TFL) is a newer alternative. The ClearPetra vacuum‑assisted renal access sheath (VA‑RAS) adds irrigation and suction during mini‑PCNL and may change how each laser performs. This interventional trial compares outcomes when mini‑PCNL with VA‑RAS is performed using high‑power Ho:YAG with MOSES technology versus TFL. Key outcomes include stone clearance, operative time, need for additional procedures, and perioperative complications in adult patients treated at a single center.
Who should consider this trial
Good fit: Adults (18+) with unilateral kidney stones larger than 15 mm who are scheduled for primary, supine, unilateral mini‑PCNL using the ClearPetra sheath and meet the study's inclusion/exclusion criteria.
Not a fit: Patients who are pregnant, have genitourinary anatomical abnormalities, uncorrected coagulopathy, are immunosuppressed, require simultaneous contralateral or ureteral stone treatment, or need other fragmentation methods are excluded and would not benefit from participating.
Why it matters
Potential benefit: If successful, the trial could identify the laser approach that produces faster and more complete stone clearance with fewer procedures and complications.
How similar studies have performed: Comparisons of Ho:YAG and TFL in ureteroscopy and standard PCNL have produced mixed results, but using either laser specifically with a vacuum‑assisted ClearPetra sheath in mini‑PCNL is novel and has not been exclusively studied.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Males or females over 18 years of age 2. Patients with kidney stones, with stone burden larger than 15 mm. 3. Patients undergoing new percutaneous access with primary, supine, unilateral mini-PCNL. Exclusion Criteria: 4. Simultaneous use of more than 1 laser platform or other form of fragmentation (e.g., ultrasonic). 5. Patients undergoing simultaneous treatment of contralateral kidney stones during the same procedure. 6. Patients undergoing simultaneous treatment of ureteral stones during the same procedure. 7. Pregnant patients. 8. Presence of genitourinary anatomical abnormalities. 9. Uncorrected coagulopathy. 10. External urinary catheters. 11. Immunosuppressed patients. 12. Non-elective procedures.
Where this trial is running
Kansas City, Kansas
- University of Kansas Medical Center — Kansas City, Kansas, United States (Recruiting)
Study contacts
- Principal investigator: Bristol Whiles, MD — University of Kansas Medical Center
- Study coordinator: Jane Ledesma
- Email: jledesma2@kumc.edu
- Phone: 913-588-8721
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.