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

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.

Study Overview

• Status: Unknown
• Conditions: Colon Diseases
• Intervention / Treatment: Device: Colon cleansing by hydrotherapy

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 Type: Interventional
• Enrollment (Anticipated): 160
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Strasbourg, France
    • Recruiting
    • Department of Hepato-Gastroenterology, Nouvel Hopital Civil
    • Contact: Gerard Gay, Prof.; Phone Number: +33 369 55 03 13; Email: gerard.gay@chru-strasbourg.fr
    • Contact: Michel Delvaux, Prof.; Phone Number: +33-369 55 03 13; Email: michel.delvaux@chru-strasbourg.fr
    • Principal Investigator: Gerard Gay, MD
    • Sub-Investigator: Michel Delvaux, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hydrocolonic cleansing; Subjects undergo colon cleansing by hydrotherapy with the study device	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.; Other Names: The Angel of Water™, a colon hydrotherapy system.
Active Comparator: Standard preparation solution; Subjects undergo colon cleansing by standard preparation solution	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.; Other Names: The Angel of Water™, a colon hydrotherapy system.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: novoGI
• Investigators: Study Director: Eran Choman, novoGI

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Anticipated): March 1, 2014
• Study Completion (Anticipated): March 1, 2014

Study Registration Dates

• First Submitted: June 4, 2013
• First Submitted That Met QC Criteria: June 4, 2013
• First Posted (Estimate): June 6, 2013

Study Record Updates

• Last Update Posted (Estimate): June 6, 2013
• Last Update Submitted That Met QC Criteria: June 4, 2013
• Last Verified: June 1, 2013

More Information

Terms related to this study

• Keywords: A colon hydrotherapy system; Hydrocolonic preparation; Preparation for colonoscopy
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Colonic Diseases
• Other Study ID Numbers: Hydro-Prep, CLPR-200-0101