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

Not Applicable

• Conditions: Colon Diseases
• Interventions: Device: Colon cleansing by hydrotherapy

• Registration Number: NCT01871584
• Lead Sponsor: novoGI

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.

Study Timeline

• Status Verified: 2013-06
• Study Start: 2013-06
• Study First Submitted: 2013-06-04
• Study First Submitted QC: 2013-06-04
• Last Update Submitted: 2013-06-04
• Study First Posted: 2013-06-06
• Last Update Posted: 2013-06-06
• Primary Completion: 2014-03
• Study Completion: 2014-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 160

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hydrocolonic cleansing	Colon cleansing by hydrotherapy	Subjects undergo colon cleansing by hydrotherapy with the study device
Standard preparation solution	Colon cleansing by hydrotherapy	Subjects undergo colon cleansing by standard preparation solution

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Department of Hepato-Gastroenterology, Nouvel Hopital Civil; 🇫🇷 Strasbourg, France