EUCTR2019-004374-25-IT进行中(未招募)1 期
Thoracic duct identification with Indocyanine green fluorescence during minimally invasive esophagectomy with patient in prone position - VERDEDT
AZIENDA OSPEDALIERO-UNIVERSITARIA UDINE0 个研究点目标入组 49 人开始时间: 2021年5月24日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 49
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Patients aged 18 or over
- •2. American Society of Anesthesiologists’ (ASA) class I, II or III;
- •3. Elective surgery patients;
- •4. Patients’ written acceptance to be included in the study.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 49
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 49
排除标准
- •1. Class IV-V of the American Society of Anesthesiologists (ASA)
- •2. Patients with hyperthyroidism and / or autoimmune adenomas of the thyroid
- •3. Allergy to contrast medium, hypersensitivity to iodine, indocyanine green or sodium iodide.
- •4. Patients who cannot undergo transthoracic esophagectomy
- •5. Pregnancy or breastfeeding or positive pregnancy test (to be performed in potentially fertile women)
- •6. Severe kidney failure (estimated GFR <30 mL / min / 1.73 m2 at the time of screening)
- •7. Participation in a clinical study in which an experimental drug was administered within 30 days or 5 half-lives of the study drug
- •8. Any clinical condition that in the investigator's judgment would make the patient unsuitable for the study
- •9. Patients who refuse to give their written consent to participate in the study
研究者
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