NCT07696793招募中4 期
Efficacy and Tolerability of a Simethicone-containing Evacuating Solution for Colorectal Cancer Screening Colonoscopy: a Randomized Parallel Comparative Trial CLEAN+
Fundacion Clinic per a la Recerca Biomédica1 个研究点 分布在 1 个国家目标入组 818 人开始时间: 2026年5月18日最近更新:
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 818
- 试验地点
- 1
- 主要终点
- Adenoma detection rate
研究概览
简要总结
Study to evaluate the efficacy and tolerability of a simethicone-containing evacuating solution for colorectal cancer screening colonoscopy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Investigator)
盲法说明
blind endoscopist, unblinded nurse and patient
入排标准
- 年龄范围
- 50 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women aged 50 to
- •Have participated in the early detection program for colorectal cancer.
- •Positive result in the fecal occult blood test (≥20 μg Hb/g feces).
- •Scheduled screening colonoscopy at Hospital Clínic de Barcelona.
- •Signed informed consent form.
排除标准
- •Severe renal failure (grade IV or V) (Annex 6, Stages of Renal Impairment) and/or congestive heart failure (New York Heart Association Scale Class III and IV) (Annex 7, NYHA Scale).
- •Colonoscopy within the last year.
- •Barthel Index of <20 (Annex 5, Barthel Index) and who also meet the Rome IV Criteria for the diagnosis of functional constipation (Annex 8, Rome IV Criteria).
- •Mental disability or severe mental disorder (schizophrenia and other psychotic disorders, recurrent severe major depressive disorders, severe obsessive-compulsive disorder, severe personality disorders, and bipolar disorders).
- •Do not understand spoken or written Catalan or Spanish.
- •Partial or total colon resection.
- •Personal history of CRC or colorectal pathology that requires specific follow-up (ulcerative colitis, Crohn's disease, or colorectal adenomas).
- •Terminal illness or serious illness/disability that contraindicates subsequent colon study.
- •Gastrointestinal disorders that contraindicate the use of study products (gastric emptying disorders, gastrointestinal perforation or obstruction, ileus, toxic megacolon).
- •Hypermagnesemia.
- •Rhabdomyolysis.
- •Phenylketonuria.
- •Glucose-6-phosphate dehydrogenase deficiency.
- •Hypersensitivity to the active ingredients of excipients.
- •Pregnancy or breastfeeding.
结局指标
主要结局
Adenoma detection rate
时间窗: week 2 (Colonoscopy visit)
Adenoma detection rate, defined as the proportion of patients with at least one adenoma in relation to the total number of subjects in each study group (Clensia® Group (Group A); Citrafleet® Group (Group B)).
次要结局
- Lesion detection rate(week 2 (Colonoscopy visit))
- Adenomas per colonoscopy(week 2 (Colonoscopy visit))
- Presence of foam(week 2 (Colonoscopy visit))
- Presence of bubbles(week 2 (Colonoscopy visit))
- Quality of colon cleansing(week 2 (Colonoscopy visit))
- Need for washing tools during colonoscopy(week 2 (Colonoscopy visit))
- Cecal intubation rate(week 2 (Colonoscopy visit))
- Cecal intubation time(week 2 (Colonoscopy visit))
- Endoscope removal time(week 2 (Colonoscopy visit))
- Requires repeat colonoscopy due to poor preparation(week 2 (Colonoscopy visit))
- Adherence to the intake of the preparation(week 2 (Colonoscopy visit))
- Ease of taking the preparation(week 2 (Colonoscopy visit))
- Palatability of the preparation(week 2 (Colonoscopy visit))
- Willingness to repeat the intake of the preparation(week 2 (Colonoscopy visit))
- Overall satisfaction with the intake of the preparation(week 2 (Colonoscopy visit))
- Endoscopist's satisfaction with the cleaning of faecal remains and bubbles(week 2 (Colonoscopy visit))
- Rate of adverse events(week 2 (Colonoscopy visit) and week 4 (visit 2))
研究者
研究点 (1)
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