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Colonic Irrigation for Colonoscopy Preparation

NCT02647229 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2016-09-28

No results posted yet for this study

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.

Conditions

  • Colonoscopy

Interventions

OTHER

Isosmotic bowel cleansing preparation

Isosmotic Preps contain polyethylene glycol (PEG) and are osmotically balanced, high-volume, nonabsorbable, and nonfermentable electrolyte solutions.

OTHER

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

Sponsors & Collaborators

Principal Investigators

  • Basil Lucak · New York University Medical School

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2016-10-31
Completion
2016-10-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02647229 on ClinicalTrials.gov