Clinical trial NCT01871584: A Post Marketing Study of Angel of Water™ for Colon Cleansing as Preparation for Colonoscopy
Official title: A Prospective, Single Center, Single-blinded, Randomized Study, of the Angel of Water™ for Colon Cleansing as Preparation for Colonoscopy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colon Diseases
Keywords: A colon hydrotherapy system
Hydrocolonic preparation
Preparation for colonoscopy
Lead sponsor: novoGI
Sponsor class: INDUSTRY
First posted: 2013-06-06
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

Eligibility criteria: 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

Primary outcomes:
measure: Colon Cleanliness during colonoscopy according to Boston Bowel Preparation Scale (BBPS)
timeFrame: Per patient: the end of procedure; For study: approx. 10 months
Secondary outcomes:
measure: Subject's Attitude: rating the preparation procedure with respect to ease, convenience and comfort
timeFrame: Per patient: the end of procedure; For study: approx. 10 months
Other outcomes:
measure: Duration of colonoscopy examination
timeFrame: Per patient: the end of procedure; For study: approx. 10 months
Locations:
city: Strasbourg
country: France
facility: Department of Hepato-Gastroenterology, Nouvel Hopital Civil
Study officials:
affiliation: novoGI
name: Eran Choman
role: STUDY_DIRECTOR
References: