Comparison of Holmium Laser and Thulium Laser for Mini PCNL (NCT06266793) | Clinical Trial Compass
By InvitationNot Applicable
Comparison of Holmium Laser and Thulium Laser for Mini PCNL
United States52 participantsStarted 2024-03-07
Plain-language summary
This is a single institution, single surgeon, randomized controlled trial to evaluate the Boston Scientific Lumenis Pulse 120H Moses 2.0 holmium laser versus the Olympus Soltive Superpulsed thulium fiber laser (TFL) for medium-to-large stones in the mini PCNL setting.
Who can participate
Age range
21 Years – 90 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Scheduled to undergo mini PCNL for nephrolithiasis
* Stone burden (multiple stones acceptable) with largest stone 1cm - 3 cm in greatest dimension on bone window of noncontrast CT within a 6 month preoperative period.
* Able to give informed consent
* Age 21 or older
Exclusion Criteria:
* Patients scheduled to undergo concurrent non-PCNL procedure such as contralateral ureteroscopy
* Inability to give informed consent
* Age less than 21
* Body Mass Index (BMI) \>45
* Pregnant or breastfeeding patients
* Stone burden outside of inclusion criteria range
* Untreated urinary tract infections
* Uncontrolled bleeding disorder and coagulopathy
* Abnormal upper tract anatomy such as presence of ureteral strictures or complete ureteropelvic junction (UPJ) obstruction
* Patients with urinary diversion such as ileal conduit or neobladder
* Any preexisting medical condition or situation that, in the investigator's opinion, could put the participant at significant risk, confound the study results, or interfere significantly with the participants' participation in the study
* Are currently prescribed buprenorphine or methadone, or carry active diagnosis of chronic opioid use disorder
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.