Feasibility and Effectiveness of Colonic Irrigation

NCT ID: NCT02826967

Last Updated: 2020-07-01

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

TERMINATED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2020-06-08

Brief Summary

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This study will allow investigators to determine whether colonic irrigation may allow for a non-oral, same-day alternative to traditional oral bowel prep regimens. This in turn could lead to more persons able to undergo screening colonoscopy for colorectal cancer and thus increased cancer prevention and early detection.

Detailed Description

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The primary endpoints for this study are:

* Overall quality of bowel cleansing for each of the three segments of the colon (ascending, transverse, and descending) as measured by the Boston Bowel Preparation Score (BBPS), a validated numerical scale for bowel cleanse (0-3 for each colon segment; 0-9 total score) (6).
* Patient satisfaction, as measured by a questionnaire administered by a study investigator via follow-up phone call after completion of the colonic irrigation and subsequent colonoscopy.

Conditions

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Colonic Irrigation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Colonic Irrigation

A designated health professional will administer to the patient the colonic irrigation procedure -using the Hydro-San Plus colon therapy system, an FDA approved and ISO certified device for colonic irrigation and cleansing before endoscopic procedures (FDA #2027347).

Group Type EXPERIMENTAL

Colonic Irrigation

Intervention Type PROCEDURE

Interventions

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Colonic Irrigation

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Outpatients age 50-84 years old, who require a screening or surveillance colonoscopy
* Ability to give consent

Exclusion Criteria

* Pregnancy
* History of ulcerative colitis or Crohn's disease
* History of surgical ostomy
* History of colorectal surgery
Minimum Eligible Age

50 Years

Maximum Eligible Age

84 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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Mark Pochapin, MD

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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16-00578

Identifier Type: -

Identifier Source: org_study_id

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