A Prospective, Single Center, Single-blinded, Randomized Study, of the Angel of Water™ for Colon Cleansing as Preparation for Colonoscopy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Colon Cleanliness during colonoscopy according to Boston Bowel Preparation Scale (BBPS)
研究概览
简要总结
The aim of this study is to demonstrate the efficacy of the hydrocolonic lavage method in order to prepare the colon prior to performing a colonoscopy, by comparison the hydrotherapy to standard preparation solution.
Hypothesis: Colon cleansing by hydrotherapy is as good as colon cleansing by standard preparation solution.
详细描述
Colonoscopy is the current standard method for evaluation of the colon. It has an indispensable place in the diagnosis and treatment of colon diseases. Diagnostic accuracy and therapeutic safety of colonoscopy depends on the quality of the colonic cleansing or preparation. Good preparation of the bowel is necessary prior to colonoscopy, to allow clear visualization of the bowel wall and any pathology within. The proposed study is a post-marketing study in which the study device, the Angel of Water system will be used for hydrotherapy of the colon in adult subjects scheduled for elective colonoscopy, instead of standard preparation solution. The effectiveness of the hydrotherapy in comparison to the standard preparation will be defined by evaluating colon cleanliness, subject's attitude and the duration of colonoscopy procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is >= 18 and ≤ 80 years old, referred to colonoscopy
- •Subject is able and agrees to sign the informed consent and follow the study requirements
排除标准
- •Myocardial infarction within the last 3 months
- •Symptomatic congestive heart failure
- •Established renal failure (serum creatinine > 2.0 mg/dL)
- •Previous abdominal surgery, colectomy, or recent colon or rectal surgery
- •Abdominal hernia
- •Partial or complete intestinal obstruction
- •Acute exacerbation of inflammatory bowel disease
- •Intestinal perforation
- •Fissures or fistula
- •Grade III or IV hemorrhoids
- •Carcinoma of the rectum
- •Distal rectal anastomosis
- •Hypokalemia
- •Subject's weight > 400 lbs. /182 kg
- •Participation in another study that may affect the results of this study
结局指标
主要结局
Colon Cleanliness during colonoscopy according to Boston Bowel Preparation Scale (BBPS)
时间窗: Per patient: the end of procedure; For study: approx. 10 months
The primary study outcome is the Boston Bowel Preparation Scale (BBPS) score evaluating during colonoscopy. The BBPS is a valid scale for measuring bowel preparation as well as colonoscopy outcomes, as it reflects the colon's cleanliness during the inspection phase of the procedure.
次要结局
- Subject's Attitude: rating the preparation procedure with respect to ease, convenience and comfort(Per patient: the end of procedure; For study: approx. 10 months)