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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hydrocolonic cleansing | Experimental | Subjects undergo colon cleansing by hydrotherapy with the study device |
|
| Standard preparation solution | Active Comparator | Subjects undergo colon cleansing by standard preparation solution |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Colon cleansing by hydrotherapy | Device | The Angel of Waterâ„¢ system will be used for hydrotherapy of the colon in adult subjects scheduled for elective colonoscopy. |
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of colonoscopy examination | The duration of the colonoscopy procedure will be recorded for each subject. The duration is defined as the time from insertion into the rectum to the time when the colonoscopy is withdrawn across the anus. | Per patient: the end of procedure; For study: approx. 10 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eran Choman | Contact | +972-9-860 3016 | Eran.Choman@novogi.com |
| Name | Affiliation | Role |
|---|---|---|
| Eran Choman | novoGI | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Hepato-Gastroenterology, Nouvel Hopital Civil | Recruiting | Strasbourg | France |
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| ID | Term |
|---|---|
| D003108 | Colonic Diseases |
| ID | Term |
|---|---|
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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