Use of a Colon Irrigation Device as a Preparation for a Colon Visualization Procedure

Study Overview
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Brief Summary
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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.

Detailed Description
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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 Day of Procedure: 6am- Dulcolax 2 tabs 8am- HyGIeaCare Procedure 9am- ingest PillCam Colon 10am- ingest Reglan At small bowel detection, drink 10oz SUPREP and 32oz water 3hrs later- drink 10oz SUPREP and 32oz water 2hrs later- insert suppository 2hrs later- light meal

Official Title
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Colon Irrigation Using HyGIeaCare as Prep for PillCam COLON Procedure

Conditions
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Screening Colonoscopy

Intervention / Treatment
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* Device: HyGIeaCare colon irrigation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient referred for the PillCam COLON procedure Exclusion Criteria: - 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 Pregnancy 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Interventional Model Description: HyGIeaCare colon irrigation procedure and PillCam COLON procedure
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HyGIeaCare and PillCam COLON<br>Patient will receive the HyGIeaCare colon irrigation prior to their PillCam COLON procedure | Device: HyGIeaCare colon irrigation<br>* PillCam COLON for visualization of bowel lining<br>* Other names: PillCam COLON;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness of 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). | 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. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of adverse events | The CTCAE tool will be used to evaluate outcomes | To be evaluated the day of the procedure | 
| Evaluation of patient satisfaction | A standardized questionnaire will be used to measure outcomes | To be evaluated on the day of the procedure |