Colon Irrigation Using HyGIeaCare as Prep for PillCam COLON Procedure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Effectiveness of colon irrigation
研究概览
简要总结
A prospective, single center, study to evaluate the effectiveness of the HyGIeaCare Prep when used in combination with the PillCam COLON; the hypothesis is that the HyGIeaCare Prep will be easier for the patients to tolerate, and the results will be as good as the existing oral preparation.
详细描述
Patients who agree to participate in the study will have their HyGIeaCare procedure and then will present to the PillCam COLON room, in the same suite for the PillCam COLON procedure.
The commercial preparations for the PillCam COLON procedure will be the same, except the HyGIeaCare procedure will replace the split polyethylene glycol-electrolyte solution preparation.
2-days prior:
- Normal diet
- 10 glasses of liquid
1-day prior:
- Clear liquid diet all day
- Dulcolax 2 tabs at 2pm and 2 tabs at 8pm
- Nothing by mouth after midnight
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
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
- 是
入选标准
- •Patient referred for the PillCam COLON procedure
排除标准
- •HyGIeaCare:
- •Patient has any condition that, in the opinion of the investigator, may adversely affect the compliance or safety of the patient or would limit the patient's ability to complete the study
- •Patient is treated long-term with narcotics.
- •Patient does not have any of the contraindications listed below:
- •Cardiac: Congestive heart failure (NYHA class III or IV or Ejection Fraction <50%)
- •GastrointestinaI: Intestinal perforation, carcinoma of the rectum, Fissures or fistula, Severe hemorrhoids, Abdominal hernia, recent colon or rectal surgery, abdominal surgery
- •Genitourinary: Renal insufficiency (CC < 60 ml/min/173m2), cirrhosis with ascites
- •Abdominal surgery within the last 6 months
- •PillCam COLON:
- •Subject has dysphagia or any swallowing disorder
- •Subject has congestive heart failure
- •Subject has Diabetes type I.
- •Subject has had prior abdominal surgery other than uncomplicated procedures that would be unlikely to lead to bowel obstruction based on the clinical judgment of the investigator
- •Subject has a cardiac pacemaker or other implanted electro medical device.
- •Subject has any allergy or other known contraindication to the medications used in the study
- •Subject is expected to undergo MRI examination within 7 days after ingestion of the capsule.
- •Subject with any condition believed to have an increased risk for capsule retention such as Crohn's disease, intestinal tumors, radiation enteritis, and incomplete colonoscopies due to obstructions or NSAID enteropathy.
- •Subject with gastrointestinal motility disorders
- •Subject has known delayed gastric emptying
- •Subject has any condition, which precludes compliance with study and/or device instructions.
- •Women who are either pregnant or nursing at the time of screening, or are of child-bearing potential and do not practice medically acceptable methods of contraception.
- •Subject suffers from life threatening conditions
- •Subject currently participating in another clinical study
结局指标
主要结局
Effectiveness of colon irrigation
时间窗: Immediately after colon irrigation, PillCam COLON will be administered. A video will be taken of the procedure which will be used to measure the effectiveness of the colon irrigation.
Effectiveness of the HyGIeaCare Prep will be measured using a 5-point scale to evaluate the visual quality of bowel cleanliness identified in the PillCam Colon video (Excellent, Good, Fair, Adequate, Poor).
次要结局
- Evaluation of adverse events(To be evaluated the day of the procedure)
- Evaluation of patient satisfaction(To be evaluated on the day of the procedure)