NCT02826967

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 6, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 11, 2016

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 8, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 8, 2020

Completed
Last Updated

July 1, 2020

Status Verified

June 1, 2020

Enrollment Period

4 years

First QC Date

July 6, 2016

Last Update Submit

June 29, 2020

Conditions

Colonic Irrigation

Keywords

Hydro-San Plus colonic irrigation systemScreening colonoscopy

Outcome Measures

Primary Outcomes (2)

  • 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)

    Boston Bowel Preparation Score (BBPS), a validated numerical scale for bowel cleanse (0-3 for each colon segment; 0-9 total score)

    15 Minutes

  • 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.

    15 Minutes

Study Arms (1)

Colonic Irrigation

EXPERIMENTAL

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).

Procedure: Colonic Irrigation

Interventions

Colonic IrrigationPROCEDURE
Colonic Irrigation

Eligibility Criteria

Age50 Years - 84 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Pregnancy
  • History of ulcerative colitis or Crohn's disease
  • History of surgical ostomy
  • History of colorectal surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

Study Officials

  • Mark Pochapin, MD

    New York University Medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2016

First Posted

July 11, 2016

Study Start

June 1, 2016

Primary Completion

June 8, 2020

Study Completion

June 8, 2020

Last Updated

July 1, 2020

Record last verified: 2020-06

Locations

US(1)