[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07087977":3,"trial-entities:NCT07087977":107,"trial-summary:NCT07087977":110},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":25,"primary_purpose":26,"phases":27,"enrollment_info":29,"interventions":32,"primary_outcomes":44,"secondary_outcomes":49,"sex":63,"minimum_age":64,"maximum_age":65,"healthy_volunteers":15,"eligibility_criteria":66,"std_ages":70,"locations":73,"central_contacts":91,"overall_officials":93,"references":95,"see_also_links":106},"NCT07087977","STUDY00161413","HoYAG vs TFL in miniPCNL With ClearPetra","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","RECRUITING","2027-12-01","2026-05","2026-05-06","2025-08-22","University of Kansas Medical Center","OTHER",false,"Mini percutaneous nephrolithotripsy is the treatment of choice for kidney stones over 2cm. This procedure commonly uses laser energy for breaking the stones, and among possible laser platforms, Hoyag and thulium fiber laser are FDA approved. Recently, this procedure has also included the use of vacuum assisted renal access sheaths, which allows suction to be employed together with the breaking of stones. This study intends to compare outcomes when using either laser platforms with suction sheaths in participants undergoing mini percutaneous nephrolithotripsy for the treatment of kidney stones.","Due to the reduced diameter sheath of miniaturized percutaneous nephrolithotripsy (miniPCNL), surgical outcomes commonly rely on stone fragmentation provided by a laser energy source. Holmium:yttrium-aluminum-garnet laser (HoYAG) has long been considered the gold-standard for lithotripsy, but this position has been challenged by the introduction of the thulium fiber laser (TFL) since its approval for clinical use in 2017. In the same manner, the recently developed ClearPetra™(MicroTech Endoscopy®, China) vacuum-assisted renal access sheath (VA-RAS) is a novel technology that allows for concomitant irrigation and suction during the procedure.\n\nNo prior studies to date have exclusively investigated mini-PCNL outcomes with Ho:YAG and TFL when using VA-RAS. This study addresses the literature paucity regarding the outcomes when utilizing the high-power Ho:YAG with MOSES technology vs. TFL in mini-PCNL with VA-RAS. This study hypothesizes that the Ho:YAG may provide more efficient stone clearance, secondary to its superior ability to fragment stones when compared to the TLF laser, which primarily dusts despite the laser settings utilized.",[19,20],"Nephrolithiasis","Kidney Stone",[19,20,22,23,24],"ClearPetra","HoYAG","TFL","INTERVENTIONAL","TREATMENT",[28],"NA",{"count":30,"type":31},150,"ESTIMATED",[33,39],{"type":34,"name":35,"description":36,"armGroupLabels":37},"DEVICE","HoYAG laser","Patients will be randomly assigned (1:1) to HoYAG laser or TFL laser group for miniPCNL surgery according to standard of care.",[38],"MiniPCNL with HoYAG",{"type":34,"name":40,"description":41,"armGroupLabels":42},"TFL laser platform","Patients will be randomly assigned (1:1) to HoYAG or TFL laser group for MiniPCNL surgery according to standard of care.",[43],"MiniPCNL with TFL",[45],{"measure":46,"description":47,"timeFrame":48},"Stone Lithotripsy time between HoYAG and TFL","Time from scope insertion to scope removal","Procedure",[50,53,57,60],{"measure":51,"description":52,"timeFrame":48},"Total operative time between HoYAG and TFL","Time from time-out to procedure finish",{"measure":54,"description":55,"timeFrame":56},"Stone Free Status between ClearPetra and traditional approach","Stone free is defined as no residual stones larger than 2mm in post operative CT scan","90 days",{"measure":58,"description":59,"timeFrame":48},"Laser Energy","Laser efficiency will be measured by evaluating the laser energy in kilojoules used during the procedure.",{"measure":61,"description":62,"timeFrame":48},"Laser Time","Laser efficiency will be measured by evaluating the time in minutes the laser was used during the procedure.","ALL","18 Years",null,{"inclusion":67,"exclusion":68,"raw_text":69},[],[],"Inclusion Criteria:\n\n1. Males or females over 18 years of age\n2. Patients with kidney stones, with stone burden larger than 15 mm.\n3. Patients undergoing new percutaneous access with primary, supine, unilateral mini-PCNL.\n\n   Exclusion Criteria:\n4. Simultaneous use of more than 1 laser platform or other form of fragmentation (e.g., ultrasonic).\n5. Patients undergoing simultaneous treatment of contralateral kidney stones during the same procedure.\n6. Patients undergoing simultaneous treatment of ureteral stones during the same procedure.\n7. Pregnant patients.\n8. Presence of genitourinary anatomical abnormalities.\n9. Uncorrected coagulopathy.\n10. External urinary catheters.\n11. Immunosuppressed patients.\n12. Non-elective procedures.",[71,72],"ADULT","OLDER_ADULT",[74],{"facility":13,"status":8,"city":75,"state":76,"zip":77,"country":78,"contacts":79,"geoPoint":88},"Kansas City","Kansas","66160","United States",[80,85],{"name":81,"role":82,"phone":83,"email":84},"Jane Ledesma","CONTACT","913-588-8721","jledesma2@kumc.edu",{"name":86,"role":87},"Bristol Whiles, MD","PRINCIPAL_INVESTIGATOR",{"lat":89,"lon":90},39.11417,-94.62746,[92],{"name":81,"role":82,"phone":83,"email":84},[94],{"name":86,"affiliation":13,"role":87},[96,100,103],{"pmid":97,"type":98,"citation":99},"34902273","BACKGROUND","Li P, Huang Z, Sun X, Yang T, Wang G, Jiang Y, Ke C, Li J. Comparison of Vacuum Suction Sheath and Non-Vacuum Suction Sheath in Minimally Invasive Percutaneous Nephrolithotomy: A Meta-Analysis. J Invest Surg. 2022 May;35(5):1145-1152. doi: 10.1080\u002F08941939.2021.1995538. Epub 2021 Dec 13.",{"pmid":101,"type":98,"citation":102},"33470685","Liu Y, Zhu W, Zeng G. Percutaneous nephrolithotomy with suction: is this the future? Curr Opin Urol. 2021 Mar 1;31(2):95-101. doi: 10.1097\u002FMOU.0000000000000854.",{"pmid":104,"type":98,"citation":105},"30729311","Traxer O, Keller EX. Thulium fiber laser: the new player for kidney stone treatment? A comparison with Holmium:YAG laser. World J Urol. 2020 Aug;38(8):1883-1894. doi: 10.1007\u002Fs00345-019-02654-5. Epub 2019 Feb 6.",[],{"nct_id":4,"conditions":108,"biomarkers":109},[19],[],{"nct_id":4,"found":111,"summary":112,"prompt_version":122},true,{"design":113,"status":114,"heading":115,"summary":116,"follow_up":117,"word_count":118,"commitments":119,"compensation":120,"drugs_mentioned":121},"This is an interventional study where 150 participants will be randomly assigned to receive either the HoYAG laser or the TFL laser during their miniPCNL surgery.","completed","Comparing Lasers for Kidney Stone Removal","This study is comparing two types of lasers, HoYAG and TFL, used during mini percutaneous nephrolithotripsy (miniPCNL) surgery for kidney stones. MiniPCNL is a procedure to remove kidney stones larger than 15mm. Both lasers are used with a special vacuum-assisted sheath called ClearPetra, which helps with suction during the procedure. We want to see if one laser is better at breaking up stones than the other. You might be able to join if you are over 18, have kidney stones larger than 15mm, and are having your first miniPCNL surgery. The main goal is to measure how long it takes for each laser to break up the stones during the procedure. The current recruitment status is unclear.","The primary endpoint, stone lithotripsy time, is measured during the procedure.",117,"Participants will undergo miniPCNL surgery using one of the two laser types according to standard care.","Not stated in the trial record.",[],"v2"]