Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2026-01-06 @ 4:45 AM
Study NCT ID:
NCT02826967
Status:
TERMINATED
Last Update Posted:
2020-07-01
First Post:
2016-07-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility and Effectiveness of Colonic Irrigation
Sponsor:
NYU Langone Health
Organization:
Study Overview
Official Title:
Feasibility and Effectiveness of Colonic Irrigation as a Non-oral, Same-day Bowel Preparation Option in Patients Undergoing Screening or Surveillance Colonoscopy
Status:
TERMINATED
Status Verified Date:
2020-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
COVID-19 institutional restrictions on screening colonoscopies
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Detailed Description:
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.
* 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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: