We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Improving Quality of Colonoscopy Using a 3D-imager

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00519129
First Posted: August 22, 2007
Last Update Posted: August 18, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Sorlandet Hospital HF
  Purpose
Coloscopy may be a painful procedure for the patient. This is due to a loop-formation of the coloscope. A 3D-real time imager produced by Olympus creates a real-time image of the scope while a traditional fluoroscopy device will only show instant pictures. We want to investigate whether the 3D-imager causes the patient less pain and is more time consuming than ordinary fluoroscopy

Condition Intervention Phase
Pain During Colonoscopy Device: 3D-imager Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Magnetic Endoscopic Imaging Versus Standard Colonoscopy in a Routine Colonoscopy Setting: A Randomised Controlled Trial

Resource links provided by NLM:


Further study details as provided by Sorlandet Hospital HF:

Primary Outcome Measures:
  • pain during coloscopy [ Time Frame: instant ]
  • Time used to reach the coecum [ Time Frame: instant ]

Secondary Outcome Measures:
  • coecum-intubation rate [ Time Frame: instant ]
  • level achieved when the coecum can not be reached [ Time Frame: instant ]
  • Need for assistance by a colleague [ Time Frame: instant ]
  • Need for analgetics [ Time Frame: instant ]
  • Pain during the first 24 hours after coloscopy [ Time Frame: 24 hours ]
  • Polyp detection rate [ Time Frame: instant ]

Enrollment: 800
Study Start Date: August 2007
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: 3D-imager
    3D-imager vs fluoroscopy during coloscopy
    Other Name: Skopguide
Detailed Description:
Results published in Holme et.al. Gastrointestinal Endoscopy 2011;73:1215-1222.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • All patients referred for coloscopy on an out-patient basis

Exclusion Criteria:

  • Pregnancy
  • Pacemaker
  • Lack of ability to understand information given
  • Prior resection of the colon/rectum
  • Demanding analgetics prior to start of procedure
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00519129


Locations
Norway
Sorlandet Sykehus HF
Kristiansand, Norway
Sponsors and Collaborators
Sorlandet Hospital HF
Investigators
Study Director: Geir S Hoff, PhD
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sorlandet Hospital HF
ClinicalTrials.gov Identifier: NCT00519129     History of Changes
Other Study ID Numbers: SSHF-Colon-1
First Submitted: August 21, 2007
First Posted: August 22, 2007
Last Update Posted: August 18, 2011
Last Verified: August 2011

Keywords provided by Sorlandet Hospital HF:
Pain
Patient satisfaction