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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT02647229
Other study ID # 14-01351
Secondary ID
Status Withdrawn
Phase N/A
First received December 22, 2015
Last updated September 27, 2016
Start date October 2014
Est. completion date October 2016

Study information

Verified date September 2016
Source New York University School of Medicine
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date October 2016
Est. primary completion date October 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
Isosmotic bowel cleansing preparation
Isosmotic Preps contain polyethylene glycol (PEG) and are osmotically balanced, high-volume, nonabsorbable, and nonfermentable electrolyte solutions.
Colonic Hyrdrotherapy
FDA approved method of colon cleansing using constant warm water lavage with a contained temperature and pressure controlled device administered by a trained technician

Locations

Country Name City State
United States New York University School of Medicine New York New York

Sponsors (1)

Lead Sponsor Collaborator
New York University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Comparison of Boston Bowel Prep Score (BBPS) Quality of bowel preparations validated by numerical scale for bowel cleanse (0-9 best) 1 Day No
Secondary Difference in Adenoma Detection Rate (ADR) 1 Day No
Secondary Difference in the number of follow ups needed after colonoscopy 1 Day No
Secondary Difference in overall comfort and convenience between Colonic Hydrotherapy and Isosmotic Irrigation using Boston Bowel Preparation Score (BBPS) 1 Day No
Secondary 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) 1 Day No
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