Colon Diseases Clinical Trial
Official title:
A Prospective, Single Center, Single-blinded, Randomized Study, of the Angel of Water™ for Colon Cleansing as Preparation for Colonoscopy
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.
Status | Recruiting |
Enrollment | 160 |
Est. completion date | March 2014 |
Est. primary completion date | March 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor)
Country | Name | City | State |
---|---|---|---|
France | Department of Hepato-Gastroenterology, Nouvel Hopital Civil | Strasbourg |
Lead Sponsor | Collaborator |
---|---|
novoGI |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 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 The duration is defined as the time from insertion into the rectum to the time when the colonoscopy is withdrawn across the anus.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 | No |
Primary | 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 | No |
Secondary | 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 | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
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