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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2013 by novoGI.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01871584
First Posted: June 6, 2013
Last Update Posted: June 6, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
novoGI
  Purpose

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.


Condition Intervention
Colon Diseases Device: Colon cleansing by hydrotherapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Official Title: A Prospective, Single Center, Single-blinded, Randomized Study, of the Angel of Water™ for Colon Cleansing as Preparation for Colonoscopy

Resource links provided by NLM:


Further study details as provided by novoGI:

Primary Outcome Measures:
  • Colon Cleanliness during colonoscopy according to Boston Bowel Preparation Scale (BBPS) [ Time Frame: 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:
  • Subject's Attitude: rating the preparation procedure with respect to ease, convenience and comfort [ Time Frame: 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.


Other Outcome Measures:
  • Duration of colonoscopy examination [ Time Frame: Per patient: the end of procedure; For study: approx. 10 months ]
    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.


Estimated Enrollment: 160
Study Start Date: June 2013
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: The Angel of Water™, a colon hydrotherapy system.

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01871584


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

Locations
France
Department of Hepato-Gastroenterology, Nouvel Hopital Civil Recruiting
Strasbourg, France
Contact: Gerard Gay, Prof.    +33 369 55 03 13    gerard.gay@chru-strasbourg.fr   
Contact: Michel Delvaux, Prof.    +33-369 55 03 13    michel.delvaux@chru-strasbourg.fr   
Principal Investigator: Gerard Gay, MD         
Sub-Investigator: Michel Delvaux, MD         
Sponsors and Collaborators
novoGI
Investigators
Study Director: Eran Choman novoGI
  More Information

Responsible Party: novoGI
ClinicalTrials.gov Identifier: NCT01871584     History of Changes
Other Study ID Numbers: Hydro-Prep, CLPR-200-0101
First Submitted: June 4, 2013
First Posted: June 6, 2013
Last Update Posted: June 6, 2013
Last Verified: June 2013

Keywords provided by novoGI:
A colon hydrotherapy system
Hydrocolonic preparation
Preparation for colonoscopy

Additional relevant MeSH terms:
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases