A Post Marketing Study of Angel of Water™ for Colon Cleansing as Preparation for Colonoscopy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Prospective, Single Center, Single-blinded, Randomized Study, of the Angel of Water™ for Colon Cleansing as Preparation for Colonoscopy

Conditions
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Colon Diseases

Intervention / Treatment
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* Device: Colon cleansing by hydrotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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 Cirrhosis Hypokalemia Pregnancy Subject's weight > 400 lbs. /182 kg Participation in another study that may affect the results of this 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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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hydrocolonic cleansing<br>Subjects undergo colon cleansing by hydrotherapy with the study device | Device: Colon cleansing by hydrotherapy<br>* The Angel of Water™ system will be used for hydrotherapy of the colon in adult subjects scheduled for elective colonoscopy.<br>* Other names: The Angel of Water™, a colon hydrotherapy system.;|
| Active Comparator: Standard preparation solution<br>Subjects undergo colon cleansing by standard preparation solution | Device: Colon cleansing by hydrotherapy<br>* The Angel of Water™ system will be used for hydrotherapy of the colon in adult subjects scheduled for elective colonoscopy.<br>* Other names: The Angel of Water™, a colon hydrotherapy system.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Colon Cleanliness during colonoscopy according to Boston Bowel Preparation Scale (BBPS) | 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. | Per patient: the end of procedure; For study: approx. 10 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject's Attitude: rating the preparation procedure with respect to ease, convenience and comfort | Each subject will be asked to answer post cleansing questionnaire and a score will be calculated. | Per patient: the end of procedure; For study: approx. 10 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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A colon hydrotherapy system, Hydrocolonic preparation, Preparation for colonoscopy