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

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01871584
• Other study ID #: Hydro-Prep, CLPR-200-0101
• Status: Recruiting
• Phase: N/A
• First received: June 4, 2013
• Last updated: June 4, 2013
• Start date: June 2013
• Est. completion date: March 2014

Study information

• Verified date: June 2013
• Source: novoGI
• Contact: Eran Choman
• Phone: +972-9-860 3016
• Email: Eran.Choman[@]novogi.com
• Is FDA regulated: No
• Health authority: France: Committee for the Protection of PersonnesFrance: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor)

Related Conditions & MeSH terms

• Colon Diseases
• Colonic Diseases

Intervention

Device:
• Colon cleansing by hydrotherapy
The Angel of Water™ system will be used for hydrotherapy of the colon in adult subjects scheduled for elective colonoscopy.

Locations

Country	Name	City	State
France	Department of Hepato-Gastroenterology, Nouvel Hopital Civil	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
novoGI

Country where clinical trial is conducted

France, 

Outcome

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