Prospective, Single-center, Single-arm, Open-label Observational PMCF Study - Evaluation of Performance and Safety of Colonic Irrigation With the Colon Hydromat as a Non-oral Bowel Preparation for Colonoscopy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Quality of bowel preparation (Colonic Cleanliness), evaluated through the Boston Bowel Preparation Scale (BBPS).
研究概览
简要总结
This is a clinical study with a medical device that bears the CE mark (approval for marketing in the EU) and is applied within its intended use. It is a prospective, single-centre, single-arm, open-label, observational post-market clinical follow-up (PMCF) study using the "Colon Hydromat" system for bowel preparation prior to colonoscopy. The patients will be treated according to the clinical routine and in accordance with the current IFU.
Aim of the study is to confirm safety and performance (effectiveness) of colon hydrotherapy as bowel preparation for colonoscopy. Colonic irrigation is regarded as a substitute for standard oral colonic purgative solutions for colonoscopy preparation, especially for patients, who cannot tolerate oral preparations or want to have alternatives because they have experienced the current oral preparations as a burdensome process.
详细描述
This observational study is intended to answer the question, if the colon hydrotherapy (colonic irrigation with the "Colon Hydromat") works in real-life practice.
Colonic irrigation is regarded as a substitute for standard oral colonic purgative solutions for colonoscopy preparation. The advantage of colonic irrigation is that there is no unpleasant taste, it avoids the discomfort of diarrheic episode and there is no need to drink a large volume of water or fluids. The patient will receive the bowel irrigation with the "Colon Hydromat" directly before colonoscopy, at the same day. Aim of this study is to confirm performance (effectiveness), in terms of an adequate bowel preparation and safety of the "Colon-Hydromat", as alternative bowel cleansing device prior to colonoscopy. The primary performance (effectiveness) endpoint for this study is the colonic cleanliness, defined as overall quality of bowel cleansing as measured by the Boston Bowel Preparation Scale (BBPS). The primary safety endpoints for this study are adverse device events (ADE) and serious adverse device effects (SADE), product and procedure related.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •Patients with an indication of colonoscopy: inclusion is considered if patients require a colonoscopy and
- •desire an alternative bowel preparation method to standard of oral polyethylene glycol or other orally taken purgatives, or do not tolerate the oral preparations, or had an inadequate colon cleansing following traditional oral preparation, in order to complete the colonoscopy at the same day.
- •Adult patients (≥ 18 years old) having signed the informed consent.
- •Being able to respond to the self-administered questionnaire.
排除标准
- •Psychiatric conditions and inability to provide informed consent
- •Emergency colonoscopy
- •Off-label use (application is not within the IFU)
- •Pregnancy and lactation period
- •The patient has one of the contraindications listed in the IFU.
结局指标
主要结局
Quality of bowel preparation (Colonic Cleanliness), evaluated through the Boston Bowel Preparation Scale (BBPS).
时间窗: day 1
Quality of bowel preparation validated by numerical scale for bowel cleanse (0-9 best)
Adverse device events (ADE) and collection of SADE (device or procedure related).
时间窗: day 1
Assessment of ADE: Patients will be asked in questionnaires, if they had any adverse events, especially nausea, vomiting, pain/cramps, dizziness and headache and rate of patients where colonic irrigation had to be aborted. Assessment of SADE: will be assessed at end of colonoscopy by investigator.
次要结局
- BBPS for each segment.(day 1)
- Patient satisfaction.(day 1)
- User satisfaction and usability.(day 1)
- Details to colonic irrigation.(day 1)
- Colonoscopic findings.(day 1)
- Rate of colonoscopy termination.(day 1)
- Procedure time of colonoscopy.(day 1)
- Withdrawal time.(day 1)
- Cecal intubation rate.(day 1)
- Runway time.(day 1)