[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"HistoSonics, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":94},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,43,69],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":21,"conditions":22,"keywords":28,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100553466","real-world-evaluation-of-the-histosonics-edison-system-for-treatment-of-liver-tumors-across-multidisciplinary-users-boombox-master-study-100553466",false,"NCT06486454","Real-world Evaluation of the HistoSonics Edison System for Treatment of Liver Tumors Across Multidisciplinary Users (BOOMBOX: Master Study)","Inclusion Criteria:\n\n1. Subject is ≥22 years of age\n2. Subject has signed the Ethics Committee (EC), or Institutional Review Board (IRB) approved study Informed Consent Form (ICF) prior to any study related tests\u002Fprocedures and is willing to comply with study procedures and required follow-up assessments\n3. Subject's liver tumor(s) can be partially or completely treated with histotripsy\n\nExclusion Criteria:\n\n1. Subject is pregnant or planning to become pregnant or nursing (lactating) during the study period\n2. Subject is enrolled in an interventional HistoSonics-sponsored trial\n3. Subject has a concurrent condition that, in the investigator's opinion, could jeopardize the safety of the subject or compliance with the protocol","ALL","22 Years",{"count":18,"type":19},5000,"ESTIMATED","OBSERVATIONAL","The goal of this observational study is to collect information on the use of the HistoSonics Edison System for the treatment of liver tumors. The main aim is to understand how different patient characteristics and procedural characteristics may affect histotripsy success at 36 hours post-histotripsy procedure. Sub-studies to the BOOMBOX: Master Study will investigate specific populations and\u002For clinical questions with more stringent enrollment criteria, standardized testing criteria, and\u002For follow-up schedule. Any participant enrolled in the BOOMBOX: Master Study that also qualifies for a sub-study may enroll in the sub-study in parallel; sub-studies will be described in separate sub-study protocols. The BOOMBOX: Master Study will collect information about participants before, during, and after the histotripsy treatment procedure. All participants will be followed per standard clinical follow-up based on each site's clinical practice for up to 5 years after the initial histotripsy procedure or until completion of their follow-up in a sub-study, whichever is longer.",[23,24,25,26,27],"Liver Neoplasms","Primary Liver Cancer","Secondary Liver Cancer","Tumor Liver","Benign Liver Tumor",[29],"histotripsy","RECRUITING","2026-06-01",{"date":33,"type":34},"2026-06-03","ACTUAL",{"date":36,"type":34},"2024-10-14",{"date":38,"type":19},"2031-11",{"name":40,"class":41},"HistoSonics, Inc.","INDUSTRY",30,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":50,"minAge":51,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":54,"phases":55,"briefSummary":57,"conditions":58,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":68},"100609445","the-edison-system-for-treatment-of-benign-prostatic-hyperplasia-bph-using-histotripsy-100609445","NCT07214675","The Edison System for Treatment of Benign Prostatic Hyperplasia (BPH) Using Histotripsy","WOLVERINE","Inclusion Criteria:\n\n1. Subject is ≥ 50 years of age.\n2. Subject has signed the Ethics Committee (EC) approved trial Informed Consent Form (ICF) prior to any trial related tests\u002Fprocedures and is willing to comply with trial procedures and required follow-up assessments.\n3. Subject is diagnosed with BPH.\n4. Subject has a Body Mass Index (BMI) \\\u003C 27.\n5. Subject has an I-PSS ≥ 15.\n6. Subject has a prostate volume \\> 30 mL and ≤ 150 mL.\n7. Subject has a Qmax ≤ 15 mL\u002Fs with a voided volume of ≥ 125 mL during a uroflow test.\n8. Subject accepts the potential loss of ejaculatory function.\n9. Subject can tolerate general anesthesia. Index-Procedure Imaging Inclusion (Assessed day of procedure)\n10. Subject has an adequate acoustic window to visualize the prostate using the HistoSonics Edison System.\n11. Target treatment volume is ≥ 1 cm from the rectum as visualized on ultrasound, CT or MR imaging.\n\nExclusion Criteria:\n\n1. Subject has a life expectancy of less than one (1) year.\n2. Subject has a known sensitivity to contrast media and cannot be adequately pre-medicated.\n3. Subject has a post-void residual ≥ 150 mL confirmed via ultrasound.\n4. Subject has an estimated glomerular filtration rate (eGFR) ≤ 50 mL\u002Fmin, ≤ 14 days prior to the planned index procedure date.\n5. Subject has uncorrectable coagulopathy.\n6. Subject has an International Normalized Ratio (INR) value ˃ 2.0, ≤14 days prior to the planned index procedure date.\n7. Subject has had a prostatectomy.\n8. Subject has acute prostatitis.\n9. Subject has a diagnosis of or has received treatment for chronic prostatitis or chronic pelvic pain syndrome.\n10. Subject has had a urinary tract infection (UTI) ≤ 3 months prior to the planned index procedure date.\n11. Subject has bladder stones.\n12. Subject is catheter dependent or has a history of intermittent self-catheterization.\n13. Presence of prostatic calcifications in the planned treatment volume (PTV).\n14. Presence of permanent radioactive implants in the rectal wall.\n15. Subject has has a major abdominal or rectal surgery that inhibits visualization of the prostate.\n16. Subject has undergone prior locoregional therapy (e.g., Rezum, laser, Urolift, TURP emboli, or radiation).\n17. Subject has planned locoregional therapy 6 months post index procedure (e.g., Rezum, laser, Urolift, TURP emboli, or radiation).\n18. Subjects who have active cancers (not in remission for the last two years) other than non-melanomatous skin cancers.\n19. Subject is being actively treated in another pharmaceutical or device trial that has not completed its primary endpoint prior to the index procedure or may interfere with the primary outcome measure of this trial.\n20. In the investigator's opinion, histotripsy is not a treatment option for the subject.\n21. Subject has a concurrent condition that could jeopardize the safety of the subject or compliance with the protocol.\n22. Subject's prostate is not treatable by the System's working ranges (refer to User Guide).","MALE","50 Years",{"count":53,"type":19},80,"INTERVENTIONAL",[56],"NA","The purpose of this trial is to evaluate the safety of histotripsy using the HistoSonics Edison System for treatment of BPH.",[59],"Benign Prostatic Hyperplasia","2026-04-08",{"date":62,"type":34},"2026-04-09",{"date":64,"type":34},"2026-03-20",{"date":66,"type":19},"2027-10",{"name":40,"class":41},1,{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":15,"minAge":76,"maxAge":4,"enrollmentInfo":77,"targetDuration":4,"studyType":54,"phases":79,"briefSummary":80,"conditions":81,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":68},"100537821","the-histosonics-edison-system-for-treatment-of-pancreatic-adenocarcinoma-using-histotripsy-100537821","NCT06282809","The HistoSonics Edison™ System for Treatment of Pancreatic Adenocarcinoma Using Histotripsy","GANNON","Inclusion Criteria:\n\n1. Subject is ≥18 years of age.\n2. Subject has signed the Ethics Committee (EC) approved trial Informed Consent Form (ICF) prior to any trial related tests\u002Fprocedures and is willing to comply with trial procedures and required follow-up assessments.\n3. Subject is diagnosed with unresectable pancreatic adenocarcinoma (locally advanced \\[Stage 3\\] or oligometastatic disease \\[Stage 4\\]) confirmed via CT or MR imaging ≤14 days prior to the planned index procedure.\n\n   NOTE: If Stage 4 disease, there must be ≤5 metastatic tumors, the tumors must be located only in the liver and\u002For lung, and the metastatic tumors must be stable.\n4. Subject is not a surgical candidate and has received chemotherapy ≥8 weeks.\n5. Subject can tolerate general anesthesia.\n6. Subject has an Eastern Cooperative Oncology Group Performance Status (ECOG PS) grade 0-1 at baseline.\n7. Subject meets the following criteria ≤14 days prior to the planned index procedure date:\n\n   * Hemoglobin ≥ 9 g\u002FdL,\n   * Neutrophil count \\>1.0 x 10\\^9\u002FL,\n   * Platelet \\>50 x 10\\^9\u002FL,\n   * Total bilirubin ≤2.5x Institutional Upper Limit of Normal (IULN),\n   * Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤2.5x IULN,\n   * International Normalized Ratio (INR) value \\\u003C1.5,\n   * Serum creatinine \\\u003C2.0mg\u002FdL or an estimated glomerular filtration rate (eGFR) ≥45mL\u002Fmin.\n8. The targeted pancreatic tumor is ≥2 cm in longest diameter.\n9. The planned histotripsy treatment volume is ≥1.0 cm from any portion of the duodenum, small intestine, stomach, or colon as visualized on ultrasound, and CT, or MR imaging.\n10. Subject has an adequate acoustic window to visualize targeted tumor using the HistoSonics Edison System.\n11. Subject will undergo histotripsy treatment of only one (1) tumor during the index procedure, regardless of how many tumors are present in the pancreas.\n\nExclusion Criteria:\n\n1. Subject is pregnant or planning to become pregnant or nursing (lactating) during the trial period.\n2. Subject has had prior pancreatic, bilioenteric, or gastric surgery.\n3. Subject is being actively treated in another pharmaceutical or device trial that has not completed its primary endpoint prior to the index procedure or may interfere with the primary outcome measure of this trial.\n4. Subject has an uncorrectable coagulopathy.\n5. Subject has a life expectancy of less than six (6) months.\n6. Subject has a biliary or pancreatic stent and\u002For percutaneous biliary tube that encompasses the planned histotripsy treatment volume.\n7. Subject has metastases to organs other than the liver and\u002For lung (e.g., bone, brain, peritoneum).\n8. Subject has a known sensitivity to contrast media and cannot be adequately pre-medicated.\n9. Subject has an active duodenal or gastric ulcer requiring medical management.\n10. Subject is undergoing active chemotherapy for any cancer ≤7 days prior to planned index procedure date.\\*\n11. Subject is undergoing active immunotherapy or targeted therapies ≤30 days prior to planned index procedure date.\n12. Subject's targeted tumor has had prior locoregional therapy (e.g., ablation, embolization, or radiation).\n13. Subject has a planned cancer treatment (e.g., pancreatic surgery, targeted therapy, immunotherapy) exclusive of chemotherapy, ≤30 days post index procedure.\n14. Subject has planned chemotherapy ≤14 days post index procedure.\\*\n15. Subject has not recovered (CTCAE grade 2 or better) from chemotherapy or immunotherapy related toxicities (exclusive of alopecia, neuropathy, and exocrine insufficiency).\n16. In the investigator's opinion, histotripsy is not a treatment option for the subject.\n17. Subject has a concurrent condition that could jeopardize the safety of the subject or compliance with the protocol.\n18. Subject's tumor is not treatable by the System's working ranges (refer to User Guide).\n\n(\\*) Subject must not be off chemotherapy \\>21 days in total.","18 Years",{"count":78,"type":19},50,[56],"The purpose of this trial is to evaluate the safety of the HistoSonics Edison System for the destruction of pancreatic adenocarcinomas using histotripsy.",[82,83,84,85],"Pancreas Cancer","Adenocarcinoma of the Pancreas","Pancreatic Cancer","Tumor of Pancreas","2026-01-14",{"date":88,"type":34},"2026-01-15",{"date":90,"type":34},"2024-12-10",{"date":92,"type":19},"2027-01",{"name":40,"class":41},""]