Colonic Irrigation for Colonoscopy Preparation

NCT ID: NCT02647229

Last Updated: 2016-09-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2016-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Colonoscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Isosmotic bowel cleansing preparation

Isosmotic solution ingested prior to colonoscopy

Group Type ACTIVE_COMPARATOR

Isosmotic bowel cleansing preparation

Intervention Type OTHER

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

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

Group Type ACTIVE_COMPARATOR

Colonic Hyrdrotherapy

Intervention Type OTHER

FDA approved method of colon cleansing using constant warm water lavage with a contained temperature and pressure controlled device administered by a trained technician

Interventions

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Isosmotic bowel cleansing preparation

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

Intervention Type 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

Intervention Type OTHER

Other Intervention Names

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Hydro San Plus Colon therapy system

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Basil Lucak

Role: PRINCIPAL_INVESTIGATOR

New York University Medical School

Locations

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New York University School of Medicine

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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14-01351

Identifier Type: -

Identifier Source: org_study_id

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