IS-001 Injection in Patients Undergoing Robotic-Assisted Colorectal Surgery
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: filricianine.
- Кому может быть актуально
- Состояния в реестре: Ureter Injury. Базовые параметры: 16 лет — 75 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
A Phase 3 Multi-Center Efficacy Study of Filricianine Injection in Patients Undergoing Robotic-Assisted Colorectal Surgery Using the da Vinci Surgical System With Firefly® Fluorescence Imaging
Обзор
This study evaluates the safety and efficacy of intravenous injection of IS-001 to aid in intraoperative ureter structure delineation
Подробное описание
Injury to the ureter, the duct by which urine passes from the kidney into the bladder, is a well-known and serious complication of pelvic and abdominal surgery that frequently goes unrecognized intraoperatively. This study seeks to evaluate the safety and efficacy of intravenous IS-001 injection to improve surgeon ureter visualization during robotic-assisted colorectal surgery with the da Vinci® Surgical System and Firefly® imaging.
Вмешательства
- Препарат filricianine
IV injection of IS-001 filricianine with near infrared (NIR) imaging
Первичные конечные точки
- Independent reader assessment of ureter visualization by 1-5 Likert visualization rating scale from 1 not visible, 2 questionably visible, 3 low visibility, 4 visible, 5 clearly visible. [Срок оценки: 10 minutes after first injection]
Вторичные конечные точки (12)
- Independent reader assessment of ureter length delineation by line drawing on recorded frame measured in arbitrary unit length [Срок оценки: 30 minutes after the first injection]
- Independent reader assessment of ureter visualization by 1-5 Likert visualization rating scale from 1 not visible, 2 questionably visible, 3 low visibility, 4 visible, 5 clearly visible [Срок оценки: 30 miinutes after second injection]
- Independent reader assessment of ureter length delineation by line drawing on recorded frame measured in arbitrary unit length [Срок оценки: 30 minutes after second injection]
- Ureter visualization based on intraoperative surgeon's rating by 1-5 Likert visualization rating scale from 1 not visible, 2 questionably visible, 3 low visibility, 4 visible, 5 clearly visible [Срок оценки: 30 minutes after first IS-001 injection]
- Independent reader assessment of ureter visualization by 1-5 Likert visualization rating scale from 1 not visible, 2 questionably visible, 3 low visibility, 4 visible, 5 clearly visible. [Срок оценки: 45 minutes after first injection]
- Independent reader assessment of ureter visualization by 1-5 Likert visualization rating scale from 1 not visible, 2 questionably visible, 3 low visibility, 4 visible, 5 clearly visible [Срок оценки: 45 minutes after second injection]
- Concordance of ureter visualization between independent readers [Срок оценки: 10 minutes after first injection]
- Concordance of ureter visualization between independent readers [Срок оценки: 30 minutes after first injection]
- Concordance of ureter visualization between independent readers [Срок оценки: 45 minutes after first injection]
- Concordance of ureter visualization between independent readers [Срок оценки: 10 minutes after second injection]
- Concordance of ureter visualization between independent readers [Срок оценки: 30 minutes after second injection]
- Concordance of ureter visualization between independent readers [Срок оценки: 45 minutes after second injection]
Критерии участия
Критерии включения
- Male and female participants between the ages of 16 and 75, inclusive
- Participant is scheduled to undergo robotic-assisted colectomy using the da Vinci X/Xi Surgical System with SFF Fluorescence Imaging Exclusion Criteria
1\. Participant is pregnant or nursing 2. Participant has known current acute or chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) infection 3. Participant has any of the following screening laboratory values: eGFR < 30 mL/min/1.73 m2
- Aspartate aminotransferase (AST) ≥ 2.5 × ULN
- Alanine aminotransferase (ALT) ≥ 2.5 × ULN
- Total Bilirubin > 2mg/dL 4. Participant has any concomitant non-colorectal cancer 5. Participant has any circumstances that, in the judgment of the Investigator, might make them not a suitable candidate for the study 6. Participants have already been enrolled in another investigational drug or device study within the past 6 months 7. Participants with known or suspected hypersensitivity to indocyanine green (ICG) or any components of the formulation used 8. Participant is expected to receive or has received other methods for ureter identification during the surgery (e.g., ureteral stent placement, illuminated catheters, retrograde ICG injections) before the administration of IS-001 9. The duration of the surgery is expected to be less than 90 minutes as determined during preoperative planning.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Не применимо
- Модель
- Одна группа
- Маскирование
- Открытое
- Основная цель
- Профилактика
Центры проведения
США · 9 центров
- Hoag Memorial Hospital Presbyterian — Newport Beach
- Yale New Haven Hospital — New Haven
- Orlando Health — Orlando
- Mountain View Hospital — Las Vegas
- The Ohio State Unversity — Columbus
- Kettering Health — Kettering
- St David's North Austin Medical Center — Austin
- HCA Houston Healthcare Medical Center — Houston
- … и ещё 1 центр
Идентификаторы
NCT: NCT07346066 · ISI-124804-CR-3