Colon Diseases
Conditions
Keywords
A colon hydrotherapy system, Hydrocolonic preparation, Preparation for colonoscopy
Brief summary
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
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.
Interventions
DEVICEColon cleansing by hydrotherapy
The Angel of Water™ system will be used for hydrotherapy of the colon in adult subjects scheduled for elective colonoscopy.
Sponsors
novoGI
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Subject is \>= 18 and ≤ 80 years old, referred to colonoscopy 2. Subject is able and agrees to sign the informed consent and follow the study requirements
Exclusion criteria
1. Myocardial infarction within the last 3 months 2. Symptomatic congestive heart failure 3. Established renal failure (serum creatinine \> 2.0 mg/dL) 4. Previous abdominal surgery, colectomy, or recent colon or rectal surgery 5. Abdominal hernia 6. Partial or complete intestinal obstruction 7. Acute exacerbation of inflammatory bowel disease 8. Intestinal perforation 9. Fissures or fistula 10. Grade III or IV hemorrhoids 11. Carcinoma of the rectum 12. Distal rectal anastomosis 13. Cirrhosis 14. Hypokalemia 15. Pregnancy 16. Subject's weight \> 400 lbs. /182 kg 17. Participation in another study that may affect the results of this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Colon Cleanliness during colonoscopy according to Boston Bowel Preparation Scale (BBPS) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Each subject will be asked to answer post cleansing questionnaire and a score will be calculated. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Duration of colonoscopy examination | Per patient: the end of procedure; For study: approx. 10 months | 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. |
Countries
France
Contacts
Primary ContactEran Choman
Outcome results
None listed