Viewing Study NCT02243930



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Last Modification Date: 2024-10-26 @ 11:30 AM
Study NCT ID: NCT02243930
Status: COMPLETED
Last Update Posted: 2014-09-18
First Post: 2014-09-12

Brief Title: Cap-assisted Sigmoidoscopy - Influence on Pain Duration and Rate of Success
Sponsor: Zealand University Hospital
Organization: Zealand University Hospital

Study Overview

Official Title: Cap-assisted Sigmoidoscopy - Reduction in Pain Reduction in Investigation Time and Increased Rate of Success When Examined by the Less-experienced Endoscopist A Prospective Randomized Clinical Trial
Status: COMPLETED
Status Verified Date: 2014-09
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: The purpose of this study is to investigate the attachment of a transparent hood cap on the sigmoidoscope The investigators hypothesis is that this will reduce pain reduce investigation time and increases the success rate of the sigmoidoscopy The study focus on the less-experienced endoscopist
Detailed Description: The investigators randomize study subject to sigmoidoscopy - the attachment of the cap

Using a 100mm VAS scale the investigators record pain when the sigmoidoscopy reaches its intubation end-point 60cm from anus The investigators also register the time spent to this point and the rate of examinations not achieving this endpoint

Study Oversight

Has Oversight DMC: None
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?: None
Secondary IDs
Secondary ID Type Domain Link
41580 OTHER The regional committee of health research ethics None