[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"MediBeacon\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":110},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,44,63,85],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100618745","evaluation-of-protein-loading-on-measurement-of-renal-reserve-100618745",false,"NCT07335614","Evaluation of Protein Loading on Measurement of Renal Reserve","An Open Label, Single Center Study to Evaluate the Effect of Protein Loading on the Measurement of Renal Reserve Using the MediBeacon® Transdermal GFR System","Inclusion Criteria:\n\nTo be eligible for study entry, all participants must satisfy all of the following criteria:\n\n1. Age \\> 18 years - male or female\n\n   1. Eligible female non-pregnant participants who are either not of child-bearing potential or willing to use adequate contraception during the trial\n   2. Males must be willing to practice abstinence or utilize adequate contraception from dosing day to at least 7 days post-dose\n   3. For women of child-bearing potential, the participant should have a negative pregnancy test, and agrees to one of the following acceptable contraceptive methods used consistently and correctly i.e. abstinence, oral contraceptive either combined or progesterone alone; injectable progesterone, implants of levonorgestrel, estrogenic vaginal ring, percutaneous contraceptive patches, IUD device or system or male partner sterilization\n   4. Men will not donate sperm during the study and for 1 month following the last dose of study drug\n2. Participants who are capable of directly providing informed consent and who can comply with the requirements and restrictions required by the protocol\n3. eGFR \\>30 mL\u002Fmin\u002F1.73 m\\^2\n4. Capable of fasting for at least 8 hours prior to the evaluation day\n\nExclusion Criteria:\n\n1. Current use of renin-angiotensin-aldosterone system inhibitors (RAASi) including angiotensin-receptor blockers (ARBs), angiotensin-converting enzyme inhibitors (ACE-inhibitors) or direct renin inhibitors that can't be stopped at least 5 half-lives prior to the study day.\n2. Current use of sodium-glucose cotransporter-2 (SGLT2) inhibitors such as bexaglifloxin, canagliflozin, dapagliflozin, empagliflozin, ertugliflozin or others that can't be stopped at least 5 half-lives prior to the study day.\n3. Currently taking any drug classified as a sympathomimetic drug such as dobutamine, dopamine, norepinephrine, epinephrine, isoproterenol or others.\n4. Current over the counter use of cold medications containing ephedrine or weight loss drugs containing ephedra alkaloids\n5. Current history of drug use involving cocaine, mephedrone, amphetamines or methamphetamine\n6. The participant has participated in a clinical trial and has received an investigational product within the following time ranges: prior to the first dosing day in the current study: either 30 days or 5 half-lives of the investigational product (whichever duration is longer).\n7. History of skin sensitivity to adhesives (e.g. Band-Aids, surgical tape)\n8. History of severe allergic hypersensitivity reactions (unacceptable adverse events) or anaphylactoid reaction to any allergen including drugs, Lumitrace or other related products (intolerance to a drug is not considered a drug allergy).\n9. Any characteristics which, in the opinion of the investigator, makes the participant a poor candidate for participation in the clinical trial.\n10. Significant scarring, tattoos or alterations in pigmentation on the sternum or other sensor location testing areas that would alter sensor readings versus other areas of the skin\n11. Use of tanning sprays, tanning products etc. on the upper chest within 2 weeks of dosing day\n12. Use make-up, lotions, Vaseline or other products on the upper chest on the day prior to or the day of assessments\n13. Any serious or uncontrolled medical disorder, active infection, physical exam finding, laboratory finding, or psychiatric condition that in the opinion of the investigator would limit the subjects' ability to complete study requirements or may put the subject at increased risk or compromise the interpretability of study results.\n14. Participants with positive pregnancy test",true,"ALL","18 Years",{"count":20,"type":21},25,"ESTIMATED","INTERVENTIONAL",[24],"NA","The goal of this clinical trial is to evaluate the effect of protein loading on the measurement of renal reserve using the MediBeacon Transdermal glomerular filtration rate (tGFR) system. Adults with estimated glomerular filtration rate (eGFR) \\>30 ml\u002Fmin\u002F1.73 m\\^2 will be recruited to join the study. This is a potential new use for the tGFR for the assessment of renal reserve. Renal reserve is the increase in GFR that occurs in response to various stimuli, such as when one kidney is removed. The remaining kidney will often show an increase in GFR to compensate. Renal reserve is typically measured after a high protein meal and requires a reproducible stimulus and a repeated measurement of GFR.\n\nThe main questions it aims to answer are:\n\n* To characterize the effect of protein loading on GFR (dose response curve) as assessed by the MediBeacon Transdermal GFR System\n* To determine Renal Reserve in participants with chronic kidney disease (CKD) using the MediBeacon Transdermal GFR System\n* To demonstrate whether any change in GFR following the protein stimulus is associated with a change in cardiac output using non-invasive bioimpedance (NICaS)\n\nParticipants will participate in a Screening visit that will take place within 28 days of the scheduled administration of Lumitrace. On dosing day, participants will have the tGFR reusable sensor with disposable adhesive ring placed on their chest, and the MediBeacon Transdermal GFR System initiated to collect background fluorescence. Following an injection of Lumitrace and the initiation of GFR assessments, participants will ingest a high protein meal over 15-20 minutes. They will be followed at the study center for up to 6-8 hours following administration of Lumitrace. All participants will participate in a follow-up phone call approximately 7 days after the last exposure to Lumitrace. Researchers will analyze the results to see if there is a detectable difference in fluorescence clearance rate following the high protein meal.",[27],"Glomerular Filtration Rate",[29,30],"Relmapirazin","Lumitrace","NOT_YET_RECRUITING","2026-03-31",{"date":34,"type":35},"2026-04-01","ACTUAL",{"date":37,"type":21},"2026-05",{"date":39,"type":21},"2027-01",{"name":41,"class":42},"MediBeacon","INDUSTRY",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":53,"briefSummary":54,"conditions":55,"keywords":57,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":58,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":62,"locationsCount":43},"100619836","medibeacon-transdermal-gfr-system-for-the-evaluation-of-kidney-function-in-adults-with-heart-failure-100619836","NCT07349797","MediBeacon® Transdermal GFR System for the Evaluation of Kidney Function in Adults With Heart Failure","An Open Label, Single-Center, Safety and Pharmacokinetic Study of Lumitrace® Injection (Relmapirazin) and the Use of the MediBeacon® Transdermal GFR System Using the TGFR Reusable Sensor With TGFR Disposable Ring for the Evaluation of Kidney Function in Patients With Heart Failure","Inclusion Criteria:\n\n1. Age ≥18 years;\n\n   1. Eligible female non-pregnant participants who are either not of child-bearing potential or willing to use adequate contraception during the trial\n   2. Males must be willing to practice abstinence or utilize adequate contraception from dosing day to at least 7 days post-dose\n   3. For women of child-bearing potential, the participant should have a negative serum pregnancy test at screening, and agrees to one of the following acceptable contraceptive methods used consistently and correctly i.e. abstinence, oral contraceptive either combined or progesterone alone; injectable progesterone, implants of levonorgestrel, estrogenic vaginal ring, percutaneous contraceptive patches, IUD device or system or male partner sterilization\n   4. Men will not donate sperm during the study and for 1 month following the last dose of study drug.\n2. Diagnosis of symptomatic heart failure: Subject has symptomatic heart failure, ACC\u002FAHA Stage C or D, ambulatory or hospitalized for heart failure, adjudicated by a principal investigator, and meeting both of the following:\n\n   1. Clinical syndrome: Symptoms and\u002For signs consistent with heart failure (e.g., dyspnea, fatigue, edema, rales, elevated JVP), and\n   2. Objective evidence of heart failure (≥1 of):\n\n      * Left ventricular systolic dysfunction or other structural abnormalities (left atrial enlargement, left ventricular hypertrophy, diastolic dysfunction on echocardiography) or\n      * Hemodynamic evidence of elevated filling pressures by invasive or noninvasive assessment, or\n      * Elevated natriuretic peptides obtained within 90 days from enrollment: NT-proBNP ≥300 pg\u002FmL (BNP ≥100 pg\u002FmL) in sinus rhythm or NT-proBNP ≥900 pg\u002FmL (BNP ≥300 pg\u002FmL) in atrial fibrillation\n3. Participants who are capable of directly providing informed consent and who can comply with the requirements and restrictions required by the protocol\n4. Adequate venous access sufficient to allow blood sampling per protocol requirements\n\nExclusion Criteria:\n\nTo be eligible for the study, participants must not meet any of the criteria noted below:\n\n1. Intolerance to iohexol or iodine allergy\n2. Known allergy to relmapirazin or severe hypersensitivity reactions to adhesives or related products\n3. Administration of iohexol for cross-sectional imaging within a week from the dosing visit\n4. Limb amputation\n5. Primary kidney disease (e.g., glomerulonephritis or polycystic kidney disease)\n6. Acute kidney injury (AKI) or unstable kidney function at the time of dosing visit\n7. Clinical signs of excessive volume overload (edema grade 3-4 or ascites)\n8. Significant scarring, tattoos, or alterations in pigmentation on the sternum or other sensor location areas that would alter sensor readings\n9. Use of tanning sprays, tanning products, etc. on the upper chest within 2 weeks of dosing day\n10. Use of make-up, lotions, Vaseline or other products on the area of the upper chest on the day prior to or the day of dosing\n11. Participants who have received nephrotoxic agent or signs or symptoms suggestive of a condition that may result in acute kidney injury within two weeks of study entry.",{"count":52,"type":21},15,[24],"The goal of this clinical trial is to evaluate the accuracy and feasibility of transdermal glomerular filtration rate (tGFR) assessment using relmapirazin (Lumitrace) and the MediBeacon tGFR system compared to plasma clearance measurement of GFR in adults with heart failure.\n\nThe main question it aims to answer is the comparison of the transdermal-derived GFR for each participant using the MediBeacon tGFR to their nGFRBSA measurement.\n\nParticipants will participate in a Screening visit that will take place within 15 days of the scheduled administration of Lumitrace and iohexol. On dosing day, participants will have the tGFR reusable sensor with disposable adhesive ring placed on their chest, and the MediBeacon Transdermal GFR System initiated to collect background fluorescence. Following an injection of Lumitrace and iohexol and the initiation of GFR assessments, participants will be followed at the study center for 10-24 hours. All participants will participate in a follow-up phone call approximately 7 days after the last exposure to Lumitrace and iohexol. Researchers will analyze the results to compare the tGFR values to the nGFRBSA measurements for each participant.",[27,56],"Heart Failure",[29,30],{"date":34,"type":35},{"date":60,"type":21},"2026-04",{"date":39,"type":21},{"name":41,"class":42},{"id":64,"slug":65,"hasResults":11,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":4,"eligibilityCriteria":69,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":70,"targetDuration":4,"studyType":22,"phases":72,"briefSummary":74,"conditions":75,"keywords":77,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":79,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":43},"100599093","phase-1-evaluation-of-lumitrace-for-visualizing-ureters-during-abdominopelvic-surgeries-100599093","NCT07080008","Evaluation of Lumitrace for Visualizing Ureters During Abdominopelvic Surgeries","A Single Center, Open Label Pilot Study to Assess the Feasibility and Safety of Lumitrace Injection for Intraoperative Ureter Visualization Comparing White Light (WL) Fluorescence (BLUE) in Participants Undergoing Minimally Invasive Abdominopelvic Surgeries","Inclusion Criteria:\n\n1. Age \\> 18 years - male or female\n\n   1. Eligible female non-pregnant subjects who are either not of child-bearing potential or willing to use adequate contraception during the trial\n   2. Males must be willing to practice abstinence or utilize adequate contraception from dosing day to at least 30 days post-dose administration\n   3. For women of child-bearing potential, the subject should have a negative serum pregnancy test on day of surgery, and agrees to one of the following acceptable contraceptive methods used consistently and correctly from the time of consent through 30 days after Lumitrace administration; i.e. abstinence, oral contraceptive either combined or progesterone alone; injectable progesterone, implants of levonorgestrel, estrogenic vaginal ring, percutaneous contraceptive patches, IUD device or system, or male partner sterilization\n   4. Men will not donate sperm during the study and for 30 days following the last dose of Lumitrace\n2. Participants who are capable of directly providing informed consent and who can comply with the requirements and restrictions required by the protocol\n3. Participant is scheduled to undergo minimally invasive laparoscopic abdominopelvic surgery that may require ureter(s) identification\n4. eGFR≥60 mL\u002Fmin\u002F1.73m2\n\nExclusion Criteria:\n\n1. Participant has any serious or uncontrolled physical or psychiatric condition that in the opinion of the investigator would limit the their ability to complete study requirements or may put the subject at increased risk, or compromise the interpretability of study results, which makes the participant unsuitable for study participation\n2. Participant is anticipated to require ureteral stenting during surgery\n3. Participant has an active urinary tract infection requiring antibiotic therapy\n4. Participant has moderate to severe cardiac disease that limits daily functioning (New York Heart Association Class III to IV) or other medical conditions that would impact safety or study compliance\n5. Participant has any clinically relevant laboratory abnormality that could contraindicate surgery in the opinion of the PI\n6. Participant with body weight \\\u003C 30 kilogram (kg)\n7. History of severe allergic hypersensitivity reactions (unacceptable adverse events) or anaphylactoid reaction to any allergen including drugs, Lumitrace or other related products (intolerance to a drug is not considered a drug allergy)\n8. Participant has received any investigational therapy within 30 days or 5 half-lives, whichever is longer, prior to screening\n9. eGFR \\\u003C60 mL\u002Fmin\u002F1.73m2\n10. Participants with positive serum pregnancy test",{"count":71,"type":21},10,[73],"PHASE1","The goal of this clinical trial is to learn if Lumitrace and the KARL STORZ POWER LED BLUE System can be used for anatomic visualization of the ureters in participants undergoing laparoscopic abdominopelvic surgery.\n\nThe main questions it aims to answer are:\n\n* To evaluate the feasibility and clinical utility of Lumitrace to provide ureter visualization when used in tandem with the KARL STORZ POWER LED BLUE System during laparoscopic abdominopelvic surgery\n* To evaluate the safety and tolerability of a single intravenous dose of Lumitrace in participants undergoing laparoscopic abdominopelvic surgery\n\nParticipants will participate in a Screening visit that will take place within 28 days of the scheduled administration of Lumitrace.\n\nUp to 10 participants will be enrolled and will receive a single intravenous 130 mg dose of Lumitrace. Within 30 minutes of injection, the ureter visualization will be captured by the KARL STORZ POWER LED BLUE System using white light and fluorescence and the surgeon will rate ureter visualization for each illumination mode based on qualitative Likert Scales.\n\nA safety follow-up visit will occur within 14 ±7 days of Lumitrace administration.",[76],"Ureter Injury",[29,30],"RECRUITING",{"date":34,"type":35},{"date":81,"type":35},"2026-01-30",{"date":83,"type":21},"2026-12",{"name":41,"class":42},{"id":86,"slug":87,"hasResults":11,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":4,"eligibilityCriteria":91,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":92,"targetDuration":4,"studyType":22,"phases":93,"briefSummary":95,"conditions":96,"keywords":101,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":109,"locationsCount":43},"100363123","early-phase-1-feasibility-and-safety-of-mb-102-in-ocular-angiography-as-compared-to-fluorescein-sodium-100363123","NCT04008121","Feasibility and Safety of MB-102 in Ocular Angiography as Compared to Fluorescein Sodium","A Pilot Study to Assess the Feasibility and Safety of MB-102 in Ocular Angiography as Compared to Fluorescein Sodium","Inclusion Criteria:\n\n* Age \\> 18 years - male or female\n\n  1. Eligible female non-pregnant participants who are either not of child-bearing potential or willing to utilize adequate contraception during the trial\n  2. Males must be willing to practice abstinence or utilize adequate contraception from MB-102 dosing day to at least 7 days post dose\n* Participants willing to comply with study requirements\n* Participants who have signed an informed consent form\n\nAt least 5 participants will have a current history of retinal or choroidal vascular diseases.\n\nExclusion Criteria:\n\n* Women who are pregnant, lactating or planning to become pregnant during the study, or women who are of childbearing potential unwilling to utilize adequate contraception\n* Participation in another interventional trial within 30 days of treatment or concurrently enrolled in any other medical research study which could impact the results of the study\n* History of drug or alcohol abuse within the past year\n* History of severe allergic hypersensitivity reactions (unacceptable adverse events) or anaphylactoid reaction to any allergen including drugs, MB-102 and fluorescein sodium or other related products (intolerance to a drug is not considered a drug allergy).\n* Prior history of seizures\n* Current visually significant cataracts or other ophthalmic conditions that would limit appropriate collection of fundus photographs\n* Site personnel immediately associated with the study or their immediate family members\n* Unable to tolerate ophthalmologic imaging\n* Any characteristics which, in the opinion of the investigator, makes the participant a poor candidate for participation in the clinical trial (e.g. unstable medical condition including cardiovascular disease, or other conditions considered clinically significant or unstable by the Principal Investigator)\n* Prior enrollment and dosing in this study",{"count":71,"type":21},[94],"EARLY_PHASE1","The objective of this study is to evaluate the safety and image quality of the investigational dye, MB-102, compared to the control dye (fluorescein sodium) in healthy and diseased eyes using fluorescent angiography for retinal vascular disease diagnosis and monitoring.",[97,98,99,100],"Retinopathy","Retinal Vein Occlusion","Diabetic Retinopathy","Macular Degeneration",[102],"Fluorescein angiography","2026-02-02",{"date":105,"type":35},"2026-02-04",{"date":107,"type":35},"2025-11-06",{"date":83,"type":21},{"name":41,"class":42},""]