NCT07490080终止不适用
Multi-centre, Open-label, First-in-man Study With Dehisgel Used in Adult Patients Undergoing Colorectal Anastomosis Due to Rectal Cancer.
Contipro Pharma a.s.1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年10月23日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Incidence of anastomotic leak
研究概览
简要总结
A two-phase, multicenter, open-label, "first-in-human" prospective study evaluating the product's safety and efficacy in a pivotal phase.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Patients with histologically confirmed rectal adenocarcinoma (< 15 cm from the anal margin) following rectal resection with colorectal anastomosis
- •Patients with or without neoadjuvant therapy
- •Patients willing and able to provide written informed consent
- •Patients able to communicate effectively with the investigator in the local language and to understand and comply with the study requirements.
排除标准
- •Age < 18 years
- •Pregnant or breastfeeding women
- •Patients in the terminal stage of life
- •Subjects with known hypersensitivity or allergy to any component of the investigational product or to the administered antibiotics
- •Acute surgery
- •Preventive ostomy
- •Other malignancies
- •Incomplete data
结局指标
主要结局
Incidence of anastomotic leak
时间窗: 30 days
(Grade B, C according to the International Study Group of Rectal Cancer)
次要结局
未报告次要终点
研究者
研究点 (1)
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