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

novoGI160 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Masking

SINGLE

Enrollment

160

Conditions

Colon Diseases

Interventions

Colon cleansing by hydrotherapyDEVICE

The Angel of Water™ system will be used for hydrotherapy of the colon in adult subjects scheduled for elective colonoscopy.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Department of Hepato-Gastroenterology, Nouvel Hopital Civil

Strasbourg, France

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: Per patient: the end of procedure; For study: approx. 10 months

Secondary Outcomes

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.

Time frame: Per patient: the end of procedure; For study: approx. 10 months

Central Contacts

Eran Choman

CONTACT

+972-9-860 3016 Eran.Choman@novogi.com

Data from ClinicalTrials.gov

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