DRKS00024869已完成3 期
Cap Assisted Upper Endoscopy versus side viewing endoscopy for examination ofthe Major Duodenal Papilla in patients with familial adenomatous polyposis: A Randomized, Blinded, Controlled Crossover Study (CAPFAP Study) - 201901_CAPFAP
Rheinische Friedrich-Wilhelms-Universität Bonnvertreten durch die Medizinische Fakultät der Universität Bonnvertreten durch den Dekan der Medizinischen FakultätVenusberg-Campus 153127 Bonn0 个研究点目标入组 72 人开始时间: 2021年7月20日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 72
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •Age =18 years
- •- Written informed consent of the subject for voluntary participation in the study.
- •- Subjects with the ability to follow study instructions and likely to attend and complete all required visits
- •Indication-specific inclusion criteria:
- •Proven presence of a pathogenic germline variant in the APC-gene (familial adenomatous polyposis)
排除标准
- •- Subject unable to understand the nature, scope, significance and consequences of this clinical trial
- •- Patients with a physical or psychiatric condition/ a systemic disease which at the investigator’s discretion may compromise safety of the subject, may confound the trial results, may interfere with the subject’s participation in this clinical trial or may prevent sufficient compliance
- •- Simultaneously participation in another clinical trial or participation in any clinical trial involving administration of an investigational medicinal product within 30 days prior to clinical trial beginning
- •- Known or persistent abuse of medication, drugs or alcohol within 365 days prior to screening
- •Exclusion criteria regarding special restrictions for females:
- •- Current or planned pregnancy or nursing women
- •- Females of child-bearing potential, who are not using and not willing to use medically reliable methods of contraception for the entire study duration (such as oral, injectable, or implantable contracep- tives, or intrauterine contraceptive devices) unless they are surgically sterilized / hysterectomized, sexually abstinent.
- •Indication specific exclusion criteria:
- •Patients with previous upper gastrointestinal tract surgery (e. g. Whipple procedure, panceas-sparing duodenectomy)
研究者
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