[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Olympus Corporation of the Americas\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":123},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,41,67,93],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100420619","post-market-study-to-assess-itind-safety-in-comparison-to-urolift-100420619",false,"NCT04757116","Post-Market Study to Assess iTind Safety in Comparison to UroLift","A Post-Market, Prospective, Randomized, Controlled, Multicenter International Study to Assess the Safety of the Temporarily Implanted Nitinol Device (iTind) Compared to the UroLift® System in Subjects With Symptomatic Benign Prostatic Hyperplasia (BPH)","MT-08","Inclusion Criteria:\n\n1. Diagnosis of lower urinary tract symptoms presumed to be secondary to benign prostatic enlargement causing bladder outlet obstruction for which treatment is recommended\n2. Willing and able to provide informed consent\n3. Males ≥ 50 years of age or older\n4. PSA \\\u003C 4 ng\u002Fml or if the PSA is 4 - 10 ng\u002Fml, prostate cancer must be ruled out to the satisfaction of the Principal Investigator (PI) by local standard of care methods within prior 6 months\n5. Prostate volume up to 75 cc (inclusive) documented by cross-sectional imaging (TRUS, MRI, etc.). Results from standard of care imaging may be accepted up to 6 months prior to Screening\n6. International Prostate Symptom Score (IPSS) for urinary symptoms ≥ 13\n7. Maximum urinary flow rate (Qmax) of ≤ 15 mL\u002Fsec and ≥ 5 mL\u002Fsec (voided volume must be ≥ 125 mL)\n8. Willing and able to complete all study visits including questionnaires at baseline and at follow-up visits\n\nExclusion Criteria:\n\n1. History of prostate cancer or suspected, should be ruled out to the satisfaction of the PI by local standard of care methods within prior 6 months\n2. Confirmed bladder cancer within the last 2 years or currently suspected bladder cancer\n3. History of acute bacterial prostatitis within the last 2 years\n4. Median lobe obstruction of the prostate as confirmed by cross-sectional imaging\n5. PSA value \\> 10 ng\u002Fml\n6. Contraindicated for iTind or UroLift as determined by the PI\n7. Neurogenic bladder and\u002For sphincter abnormalities due to Parkinson's disease, multiple sclerosis, cerebral vascular accident, diabetes or other neurological disorders that affect bladder function\n8. Clinically significant bladder diverticulum\n9. Diagnosed with urethral stricture, meatal stenosis, bladder neck contracture, rectal disease, artificial urinary sphincter, incompetent sphincter, urinary incontinence due to incompetent sphincter\n10. Prior rectal surgery (other than hemorrhoidectomy) or history of rectal disease treatment if the therapy may potentially cause injury to site (e.g., if a transrectal probe is used), pelvic radiotherapy or radical pelvic surgery, urinary diversion surgery, prostate surgery, balloon dilation, urethral stent implantation, laser prostatectomy, or any other invasive treatment to the prostate, or penile prosthesis if it may prevent insertion of the iTind or UroLift device\n11. An active urinary tract infection during randomization\n12. Clinically significant hematuria within the last 3 months or ongoing cystolithiasis\n13. Prostate volume \\> 75 cc\n14. Post-void residual volume (PVR) \\> 250 mL\n15. Actively using catheterization or unable to void naturally\n16. Unable to complete a 2-week washout period for alpha blockers prior to procedure or unable to discontinue 5ARIs or daily use of PDE5 inhibitors by the time of procedure\n17. Taking anti-platelet or anticoagulants (except low dose aspirin - 81 mg - 100 mg) within the last 7 days prior to procedure\n18. Known or suspected allergy to nickel, titanium or polyester\u002Fpolypropylene","MALE","50 Years",{"count":20,"type":21},256,"ESTIMATED","INTERVENTIONAL",[24],"NA","The study objective is to evaluate the efficacy and safety of the iTind device compared to UroLift.",[27],"Benign Prostatic Hyperplasia (BPH)","RECRUITING","2026-07-30",{"date":31,"type":32},"2026-08-03","ACTUAL",{"date":34,"type":32},"2022-09-26",{"date":36,"type":21},"2030-05-31",{"name":38,"class":39},"Olympus Corporation of the Americas","INDUSTRY",19,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":48,"minAge":49,"maxAge":4,"enrollmentInfo":50,"targetDuration":52,"studyType":53,"phases":4,"briefSummary":54,"conditions":55,"keywords":57,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":60,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":66},"100385712","strive-post-market-registry-study-100385712","NCT04302272","STRIVE Post-Market Registry Study","The Spiration® Valve System (SVS) Post-Market Registry Study for Severe Emphysema","Inclusion Criteria:\n\n1. Adult patients with shortness of breath and hyperinflation associated with severe emphysema and evidence of low collateral ventilation.\n2. Subjects must understand and voluntarily sign an informed consent form.\n\nExclusion Criteria:\n\n1. Subjects who are not appropriate for SVS therapy based upon the US FDA-approved IFU requirements.\n2. Subjects who were withdrawn from this study for any reason will not be allowed to re-enroll.\n3. Subjects who have incomplete screening or baseline data.","ALL","18 Years",{"count":51,"type":21},150,"3 Years","OBSERVATIONAL","This is a single-arm, prospective, multi-center, Registry study to evaluate the long-term safety and effectiveness of the Spiration Valve System (SVS) for the treatment of severe emphysema in a post-market setting.",[56],"Emphysema",[56,58,59],"Chronic obstructive pulmonary disease (COPD)","Spiration valve system",{"date":31,"type":32},{"date":62,"type":32},"2021-10-09",{"date":64,"type":21},"2029-10",{"name":38,"class":39},16,{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":4,"eligibilityCriteria":73,"healthyVolunteers":11,"sex":48,"minAge":49,"maxAge":4,"enrollmentInfo":74,"targetDuration":4,"studyType":22,"phases":76,"briefSummary":77,"conditions":78,"keywords":80,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":4},"100647885","the-hanarostent-multi-hole-biliary-stent-is-indicated-for-use-in-the-palliative-treatment-of-biliary-strictures-produced-by-malignant-neoplasms-and-the-study-is-to-demonstrate-clinical-safety-and-performance-of-the-multi-hole-stent-for-the-palliative-treatment-of-malignant-biliary-obstruction-100647885","NCT07715240","The HANAROSTENT® Multi-Hole™ Biliary Stent is Indicated for Use in the Palliative Treatment of Biliary Strictures Produced by Malignant Neoplasms and the Study is to Demonstrate Clinical Safety and Performance of the Multi-Hole™ Stent for the Palliative Treatment of Malignant Biliary Obstruction.","Evaluation of the Clinical Safety and Performance of an Investigational Multi-Hole™ Biliary Stent for the Palliative Treatment of Malignant Biliary Obstruction","Inclusion Criteria:\n\n* Suspected or confirmed malignant non-hilar extrahepatic biliary obstruction including any of the following measures of biliary obstruction or patients undergoing neoadjuvant cancer treatment (chemotherapy and\u002For radiation) for malignant biliary obstruction\n\nClinical symptoms including (e.g., cholangitis, jaundice, pruritus, pale stools, and\u002For dark urine)\n\nBiochemical evidence (Tbili \\> 3mg\u002FdL)\n\nHigh quality imaging (e.g., ultrasound, CT, MRCP, or ERCP)\n\n≥ 18 years of age\n\nWilling and able to provide informed consent\n\nExclusion Criteria:\n\n* Participation in another investigational study within 90 days prior to consent\n\nIntrahepatic metastases that extensively involve both lobes of the liver\n\nPatients with a distal malignant biliary obstruction due to potential resectable disease\n\nStrictures that could not be traversed by the delivery system\n\nPerforation of any duct within the biliary tree\n\nPresence of a biliary self-expanding metal stent (SEMS), esophageal stent, or duodenal stent\n\nActive viral hepatitis\n\nLife expectancy of \\\u003C 3 months\n\nPatient has undergone (within 30 days prior to enrollment) or is planning to undergo brachytherapy with transpapillary or percutaneous implantation of intracavitary radiation sources\n\nUnwilling or unable to comply with the follow-up schedule",{"count":75,"type":21},66,[24],"The objective of this study is to demonstrate clinical safety and performance of the HANAROSTENT® Multi-Hole™ Biliary Stent for the palliative treatment of malignant biliary obstruction.",[79],"Biliary Strictures Caused by Malignant Neoplasms",[81,82,83],"Biliary Stent","Stent","Biliary Obstruction","NOT_YET_RECRUITING","2026-07-17",{"date":87,"type":32},"2026-07-21",{"date":89,"type":21},"2026-10-31",{"date":91,"type":21},"2028-05-30",{"name":38,"class":39},{"id":94,"slug":95,"hasResults":11,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":99,"eligibilityCriteria":100,"healthyVolunteers":11,"sex":48,"minAge":49,"maxAge":4,"enrollmentInfo":101,"targetDuration":4,"studyType":53,"phases":4,"briefSummary":103,"conditions":104,"keywords":109,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":122},"100561642","endoscopic-ultrasound-shear-wave-elastography-study-100561642","NCT06592820","Endoscopic Ultrasound Shear Wave Elastography Study","Endoscopic Ultrasound With Shear Wave Elastography for the Assessment of Liver Disease","EUS-SWE","Inclusion Criteria:\n\n1. 18 years of age or older\n2. Willing and able to provide informed consent\n3. Patient scheduled to undergo EUS with liver biopsy, either same session or separately; if separate, liver biopsy should be performed within 3 months of the EUS (either before or after) with no interval bariatric procedure\u002Fsurgery or weight change of \\>10% total body weight\n4. Patient scheduled to undergo or have undergone FibroScan, which should be performed within 3 months of the EUS (either before or after) with no interval bariatric procedure\u002Fsurgery or weight change of \\>10% total body weight\n5. BMI \\>\u002F=28\n6. Clinical suspicion of MASLD (hepatic steatosis with at least one of five cardiometabolic risk factors: 1) overweight or obesity, 2) elevated glucose, 3) low HDL-C, 4) hypertension, and\u002For 5) hypertriglyceridemia) or MASH (additionally characterized by the presence of inflammation and hepatocellular ballooning) with or without fibrosis, as determined by non-invasive or minimally invasive techniques (e.g. abdominal ultrasound, FibroScan)\n\nExclusion Criteria:\n\n1. Patients with surgically altered anatomy that precludes adequate endosonographic visualization of the liver parenchyma\n2. Prior history of Hepatitis B or C infection\n3. Decompensated cirrhosis (GI bleeding, ascites, encephalopathy)\n4. Histological evidence of other concomitant chronic liver disease on biopsy\n5. Inadequate liver biopsy\n6. Prior history of or current excess alcohol consumption (\\>140 g\u002Fweek and \\>210 g\u002Fweek for females and males, respectively) documented in EMR",{"count":102,"type":21},300,"This study shall be a prospective, multicenter, single arm, consecutive, interventional study conducted in a post-market setting using commercially available devices. Consecutive, eligible patients with clinical suspicion of MASLD or MASH reporting for an endoscopic ultrasound and liver biopsy for evaluation of fibrosis will be enrolled. EUS Shear Wave Elastography and Attenuation Imaging technologies will be compared to liver biopsy and FibroScan results and other non-invasive fibrosis screening modalities . The data collected during this study will be evaluated in accordance with the procedures set forth in the protocol. The main question\\[s\\] it aims to answer are:\n\n* Establish optimal cutoffs for EUS-SWE in reference to liver biopsies staging system for liver fibrosis\n* Evaluate the diagnostic performance of EUS-SWE compared to FibroScan (VCTE) and to other non-invasive fibrosis screening modalities (screening scores).\n\nParticipants will undergo:\n\n* Endoscopic Ultrasound with Shear Wave Elastography (SWE) and Attenuation Imaging (ATI)\n* Liver biopsy\n* FibroScan",[105,106,107,108],"MASLD","MASH","Fibrosis, Liver","Chronic Liver Disease",[110,111,112,113],"Shear Wave Elastography","Shear Wave","FibroScan","Attenuation Imaging","2025-09-11",{"date":116,"type":32},"2025-09-15",{"date":118,"type":32},"2025-09-03",{"date":120,"type":21},"2027-03-28",{"name":38,"class":39},2,""]