- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02647229
Colonic Irrigation for Colonoscopy Preparation
September 27, 2016 updated by: NYU Langone Health
Measuring the Effectiveness and Utility of Colonic Irrigation for Bowel Preparation in Patients Undergoing Screening or Surveillance Colonoscopy
The purpose of this physician blinded, randomized study is to determine the utility, effectiveness, and feasibility of using colonic irrigation as a substitute for standard oral colonic purgative solutions for colonoscopy preparation.
Patients will be randomized to receive either oral isosmotic solution (PEG) or colonic irrigation using the Hydro San Plus Colon therapy system, an FDA approved and isosmotic (ISO) certified device for colonic irrigation and cleansing before endoscopic procedures.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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New York
-
New York, New York, United States, 10016
- New York University School Of Medicine
-
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Consecutive adult patients (>18 years old) who require screening or surveillance colonoscopy
- Ability to give consent
Exclusion Criteria:
- Inability to obtain informed consent
- Pregnant patients
- Patients under the age of 18
- Active ulcerative colitis or crohn's disease flare
- Prisoners
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Isosmotic bowel cleansing preparation
Isosmotic solution ingested prior to colonoscopy
|
Isosmotic Preps contain polyethylene glycol (PEG) and are osmotically balanced, high-volume, nonabsorbable, and nonfermentable electrolyte solutions.
|
Active Comparator: Colonic Hyrdrotherapy
Colonic hydrotherapy is an FDA approved method of colon cleansing using constant warm water lavage with a contained temperature and pressure controlled device administered by a trained technician.2
There
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FDA approved method of colon cleansing using constant warm water lavage with a contained temperature and pressure controlled device administered by a trained technician
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Comparison of Boston Bowel Prep Score (BBPS)
Time Frame: 1 Day
|
Quality of bowel preparations validated by numerical scale for bowel cleanse (0-9 best)
|
1 Day
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Difference in Adenoma Detection Rate (ADR)
Time Frame: 1 Day
|
1 Day
|
Difference in the number of follow ups needed after colonoscopy
Time Frame: 1 Day
|
1 Day
|
Difference in overall comfort and convenience between Colonic Hydrotherapy and Isosmotic Irrigation using Boston Bowel Preparation Score (BBPS)
Time Frame: 1 Day
|
1 Day
|
preferences regarding type of bowel prep for future colonoscopy based on difference in score between Colonic Hydrotherapy and Isosmotic Irrigation using Boston Bowel Preparation Score (BBPS)
Time Frame: 1 Day
|
1 Day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Basil Lucak, New York University Medical School
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2014
Primary Completion (Anticipated)
October 1, 2016
Study Completion (Anticipated)
October 1, 2016
Study Registration Dates
First Submitted
December 22, 2015
First Submitted That Met QC Criteria
January 4, 2016
First Posted (Estimate)
January 6, 2016
Study Record Updates
Last Update Posted (Estimate)
September 28, 2016
Last Update Submitted That Met QC Criteria
September 27, 2016
Last Verified
September 1, 2016
More Information
Terms related to this study
Other Study ID Numbers
- 14-01351
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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