[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Palette Life Sciences, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":72},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,49],{"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":34,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100658230","trial-of-nasha-dx-urethral-bulking-system-100658230",false,"NCT07850804","Trial of NASHA Dx Urethral Bulking System","Trial of NASHA Dx Urethral Bulking System to Treat Stress Urinary Incontinence and Stress Predominant Mixed Urinary Incontinence","NASHA-DX","Inclusion Criteria:\n\n1. 1\\. Female, ≥ 18 years of age\n2. All women of childbearing potential must have a negative urine pregnancy test result documented prior to inclusion into the trial at Screening.\n3. SUI or stress predominant mixed urinary incontinence due to intrinsic sphincter deficiency (ISD) for at least 6 months\n4. Failed conservative therapy for stress urinary incontinence\n5. Documentation of at least 3 stress urinary incontinence episodes measured over 3 days\n6. Baseline 24-hr. pad weight test ≥ 5 g\n7. Intrinsic sphincter deficiency stress urinary incontinence defined as a urodynamic assessment in the past 6 months with Valsalva leak-point pressure (VLPP) \\\u003C 60 cm H2O and\u002For a maximal urethral closure pressure (MUCP) 20 cm H2O\n8. Clinical laboratory values such as white blood cell count, hemoglobin, AST\u002FALT, Creatinine, Bilirubin, blood glucose are within normal limits, or if abnormal, considered and documented as not clinically significant by the investigator\n9. Cleared for surgery by anesthesiologist preoperatively\n10. Life expectancy of more than 2 years\n11. Been informed of, and be able to perform, the study treatments and procedures, and signed an informed consent form.\n12. Provided authorization to use and disclose information for research purposes \\[HIPAA (Health Insurance Portability and Accountability Act of 1996; US sites) or country-specific requirement\\]\n\nExclusion Criteria:\n\n1. 1\\. Urgency Predominant Mixed urinary incontinence, confirmed by 3-day bladder diary. (greater than 50% of incontinence episodes due to urge or less than 50% of incontinence episodes due to stress).\n2. Negative cough test or lack of leakage with valsalva maneuver on physical exam\n3. Historical Detrusor overactivity as determined by urodynamic assessment within the past year\n4. Significant urethral hypermobility (e.g. vaginal swab \\> 30° from horizontal bladder neck)\n5. History of urethral bulking, artificial urinary sphincters and previous urethral surgery for incontinence or non-incontinence related indications (eg. fistulas or diverticula) are not permitted\n6. Patient may not have undergone a Mid-Urethral Sling (MUS), retropubic colpo or pubovaginal sling less than 6 months from screening\n7. Polyuria (≥ 3 L\u002F24 hrs.)\n8. Three or more culture proven bacterial UTIs in the last 12 months or 2 culture proven bacterial UTIs in the last 6 months\n9. Current urogenital infection: urethritis, cystitis, urinary tract infection or vaginitis\n10. Unevaluated hematuria\n11. No prolapse through the introitus at screening visit\n12. Body mass index (BMI) \\> 35 kg\u002Fm2\n13. Currently taking or has taken within 4 weeks prior to the screening\u002Fbaseline visit, pharmacological treatment for Overactive Bladder (OAB) (including but not limited to anti-cholinergics or beta adrenergics)\n14. Allergy to hyaluronic acid-based products or dextran or history of severe allergies or anaphylaxis including hypersensitivity to local anesthetics such as lidocaine or antibiotics used for treating urinary tract infections\n15. Active autoimmune diseases (e.g., connective tissue diseases) that could affect or confound treatment outcome\n16. Systemic corticosteroids - currently taking, or has taken, within 3 months prior to the initial treatment visit\n17. Currently has cancer or has a history of cancer within the past 5 years. Subjects with a history of skin cancer with no evidence of skin malignancy for less than 2 years, will be excluded. Note: basal cell carcinoma is not an exclusion criterion\n18. Any unstable or severe cardio-vascular disease\n19. Uncontrolled diabetes defined as HbA1c greater than 8% within the prior 6 months or at screening. Note: Patients with suspected or known diabetes mellitus type II who lack an HbA1c result within the past 6 months will have a random glucose test at screening and a HbA1c test at screening. Patients with blood glucose \\>180 mg\u002FdL will be excluded or HbA1c of 8% or greater will be excluded\n20. Active herpes genitalis (lesion, prodrome, symptoms)\n21. Currently participating in any other clinical trial or has participated in another clinical trial within 3 months prior to the screening\u002Fbaseline visit, where the outcome measures may overlap.\n22. History of drug\u002Falcohol abuse, mental dysfunction health condition, or other factors limiting her ability to cooperate fully\n23. Pregnant, lactating, or not practicing adequate contraception (refer to inclusion criteria), was intending to become pregnant, or to lactate for the duration of this study (approximately 12 months)\n24. Not physically able to perform study procedures\n25. Bladder dysfunction in the setting of known neurologic disease that negatively impacts bladder function (including but not limited to stroke, multiple sclerosis, and Parkinson's disease) or known neurologic pathology that in the opinion of the investigator contributes to bladder dysfunction\n26. Post Void Residual (PVR) \\> 150 ml on at least 2 occasions\n27. Uncontrolled bleeding disorders\n28. Impassable urethral strictures\n29. Vaginal delivery or Cesarean section within 3 months prior to the screening\u002Fbaseline visit\n30. Any other condition, which, in the opinion of the investigator, would make the subject not a suitable candidate for the study","FEMALE","18 Years",{"count":20,"type":21},314,"ESTIMATED","INTERVENTIONAL",[24],"NA","Prospective, randomized, single-blind study to evaluate the safety and efficacy of NASHA Dx investigational device compared to controlled device Bulkamid in adult women with mild, moderate and intrinsic sphincter deficiency (ISD).",[27,28,29,30,31,32,33],"Urinary Incontinence","Urinary Incontinence (UI)","Urinary Incontinence , Stress","Urinary Incontinence Due to Urethral Sphincter Incompetence","Urethral Sphincter Activity","Intrinsic Sphincter Deficiency","Pelvic Floor Dysfunction",[35],"Urethral Bulking Agents","NOT_YET_RECRUITING","2026-09-23",{"date":39,"type":40},"2026-09-30","ACTUAL",{"date":42,"type":21},"2026-09",{"date":44,"type":21},"2028-09",{"name":46,"class":47},"Palette Life Sciences, Inc.","INDUSTRY",5,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":56,"minAge":18,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":22,"phases":59,"briefSummary":60,"conditions":61,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":71},"100554220","barrigel-pprt-post-prostatectomy-radiation-therapy-trial-100554220","NCT06496256","Barrigel® PPRT (Post-Prostatectomy Radiation Therapy) Trial","Randomized Trial of Barrigel® to Increase Distance Between the Rectum and Prostate Bed to Decrease Rectal Dose in Patients Receiving Moderately Hypofractionated Radiation Therapy Who Have Had Recurrence of Prostate Cancer After Prostatectomy","Inclusion Criteria:\n\n1. Age ≥ 18 years\n2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n3. Prostatectomy surgeon notes specifying successful bilateral nerve Sparing procedure\n4. Documentation of an intra or interfascial radical prostatectomy\n5. Confirmed diagnosis of adenocarcinoma of the prostate treated primarily with radical prostatectomy with pN0 or pNX pathologic stage\n6. No radiographic evidence of local, regional, or distant metastatic disease via PSMA PET or Axumin fluciclovine F18 scan\n7. Prostate specific antigen (PSA) 0.1 ng\u002FmL or higher\n8. Intent to receive definitive radiation therapy to the prostate bed\n9. Written informed consent for study participation prior to study enrollment\n\nExclusion Criteria:\n\n1. Known allergy to hyaluronic acid\n2. Pathologic T4 disease\n3. Prior local prostate cancer therapy including cryotherapy or brachytherapy.\n4. Prior post-prostatectomy or pelvic radiation therapy\n5. Planned elective pelvic lymph node radiation therapy\n6. Prior anorectal surgery (e.g. low anterior resection, abdominoperineal resection, absence of a rectum)\n7. Inflammatory bowel disease requiring treatment with steroids (e.g. Crohn's disease, ulcerative colitis)\n8. Active connective tissue disorder including lupus or scleroderma\n9. Any urogenital abnormality that could limit the ability to access the Barrigel injection site\n10. White blood cell count \\\u003C4000\u002FuL or \\>12,000\u002FuL.\n11. Hemoglobin \\\u003C10 g\u002FdL (transfusion or other intervention to achieve this is acceptable).\n12. Active bleeding disorder or clinically significant coagulopathy defined as PTT \\>35 seconds or INR \\>1.4 or platelet count \\\u003C100,000\u002Fmm3.\n13. Serum AST\u002FALT \\>2.5 times the institutional upper limit of normal\n14. Creatinine \\>2.0 mg\u002FdL\n15. Bilirubin \\>2.0 mg\u002FdL\n16. History of chronic renal failure.\n17. History of uncontrolled diabetes (e.g. symptomatic hyperglycemia that is not controlled with medical management; fasting blood glucose \\>300 mg\u002FdL).\n18. History of acquired immunodeficiency syndrome (AIDS). Patients with controlled HIV infection (CD4+ T-cell counts ≥ 350 cells\u002FµL) and no history of AIDS-defining opportunistic infections may be included.\n19. Contraindication to having an MRI or PSMA\u002FPET scan (e.g. non-MRI compatible device).\n20. Presence of bilateral hip implants, although unilateral hip implant may be permissible if the implant is MRI compatible and does not produce artifact that interferes with any requirements of the study protocol\n21. Subject unable or unwilling to comply with study requirements\n22. Any condition that in the investigator's opinion would prevent administration or completion of study therapy","MALE",{"count":58,"type":21},84,[24],"Barrigel is intended to temporarily position the anterior rectal wall away from the prostate or prostate bed during radiotherapy treatment for prostate cancer and, in creating this space, it is the intent of Barrigel to reduce the radiation dose delivered to the anterior rectum.",[62],"Prostate Cancer","RECRUITING",{"date":65,"type":40},"2026-09-28",{"date":67,"type":40},"2024-10-31",{"date":69,"type":21},"2028-12-31",{"name":46,"class":47},13,""]