CTIS2023-503241-63-00招募中1 期
A Phase 2/3 randomized controlled semi-blinded trial to investigate safety and effectiveness in visualization of the ureters with nizaracianine triflutate, administered intravenously in up to three divided doses, in participants (18 years or older) undergoing abdominopelvic surgical procedures [TRIPHASE Trial]. - ZW800-001
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 336
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •Age = 18 years old, Scheduled to undergo a medically necessary abdominopelvic surgical procedure expected to last = 2 hours (Phase 2) or any duration (Phase 3), during which one or more ureters should be visualized during the procedure, For Phase 2, the procedure must require dissection or mobilization of one or both ureters., The planned surgical procedure is open or MIS (including robotic)., Both ureters are expected to be present and functional., Capable and willing to provide informed consent prior to study-specific procedures, Screening laboratory test results are within normal limits, or if any are outside of normal limits, they are considered by the site PI, and confirmed by the lead PI, to be clinically insignificant., Negative pregnancy test in women of childbearing potential
排除标准
- •For Phase 2 only, a prior history of abdominopelvic surgery, major abdominopelvic trauma, abdominal or pelvic radiation treatment, intraperitoneal therapy, inflammatory bowel disease, diverticular disease, endometriosis, pelvic inflammatory disease, or peritonitis., Impaired renal function defined as an eGFR < 50 mL/min/1.73m2, Impaired liver function defined as values > 1.5X the ULN for alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), and total bilirubin, or < LLN for albumin, Coagulopathy as manifested by INR > 1.3 (unless patient is on anti-coagulants), Subjects with a marked baseline prolongation of QT/QTc interval (e.g., a QTc interval > 480 msec [CTCAE grade 1] using Fridericia’s QT correction factor, History of a clinically significant allergy or anaphylaxis to a component of the IMP, The planned use of an 800 nm NIR fluorophore that is not nizaracianine (e.g., indocyanine green or pafolacianine) immediately before, during, or immediately after the planned abdominopelvic procedure., Known sensitivity to fluorescent light, Alcohol or recreational drug use that meets DSM5 criteria for moderate or severe substance use disorder, Pregnant or breastfeeding, or lack of effective contraception for at least one week post-surgery in male or female subjects with reproductive potential: for males, condom use; for females, oral contraceptives, diaphragm, or IUDs, Any condition that the investigator considers to be potentially jeopardizing to the study subject’s well-being or the study’s objectives., Participated in an interventional clinical research study within the previous 30 days., Known cardiovascular or pulmonary disease, renal or liver dysfunction, immunological disease, diabetes, or active cancer that would render the study subject unfit for surgery, The planned surgical procedure is renal transplant or nephrectomy [note: partial nephrectomy is permitted provided that estimated GFR is not expected to fall below normal age-based limits], Prior renal transplant
研究者
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