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

NCT01871584 | Unknown

• 1 other identifier: Hydro-Prep, CLPR-200-0101
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Colon Diseases

Keywords

A colon hydrotherapy system; Hydrocolonic preparation; Preparation for colonoscopy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Other Outcomes (1)

• Duration of colonoscopy examination

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

Study Arms (2)

Hydrocolonic cleansing

EXPERIMENTAL

Subjects undergo colon cleansing by hydrotherapy with the study device

Device: Colon cleansing by hydrotherapy

Standard preparation solution

ACTIVE COMPARATOR

Subjects undergo colon cleansing by standard preparation solution

Device: Colon cleansing by hydrotherapy

Interventions

Colon cleansing by hydrotherapy DEVICE

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

Also known as: The Angel of Water™, a colon hydrotherapy system.

Hydrocolonic cleansing; Standard preparation solution

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is \>= 18 and ≤ 80 years old, referred to colonoscopy
• Subject is able and agrees to sign the informed consent and follow the study requirements

You may not qualify if:

• Myocardial infarction within the last 3 months
• Symptomatic congestive heart failure
• Established renal failure (serum creatinine \> 2.0 mg/dL)
• Previous abdominal surgery, colectomy, or recent colon or rectal surgery
• Abdominal hernia
• Partial or complete intestinal obstruction
• Acute exacerbation of inflammatory bowel disease
• Intestinal perforation
• Fissures or fistula
• Grade III or IV hemorrhoids
• Carcinoma of the rectum
• Distal rectal anastomosis
• Cirrhosis
• Hypokalemia
• Pregnancy

Sponsors & Collaborators

• novoGI: lead

Study Sites (1)

Department of Hepato-Gastroenterology, Nouvel Hopital Civil

Strasbourg, France

RECRUITING

MeSH Terms

Conditions

Colonic Diseases

Condition Hierarchy (Ancestors)

Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Eran Choman

  novoGI

  STUDY DIRECTOR

Central Study Contacts

Eran Choman

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2013
• First Posted: June 6, 2013
• Study Start: June 1, 2013
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: June 6, 2013

Record last verified: 2013-06

Locations

FR (1)