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OpenTrials
Completed

NCT Number: NCT00519129

Improving Quality of Colonoscopy Using a 3D-imager

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

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Key information

Conditions

Pain During Colonoscopy Behavior Health Behavior Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Patient Satisfaction Signs and Symptoms Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Sorlandet Sykehus HF

Kristiansand, Norway

About this study

Results published in Holme et.al. Gastrointestinal Endoscopy 2011;73:1215-1222.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

3D-imager

Device

3D-imager vs fluoroscopy during coloscopy

Other names: Skopguide

Primary outcomes

  1. pain during coloscopy

    Time frame: instant

  2. Time used to reach the coecum

    Time frame: instant

Secondary outcomes

  1. coecum-intubation rate

    Time frame: instant

  2. level achieved when the coecum can not be reached

    Time frame: instant

  3. Need for assistance by a colleague

    Time frame: instant

  4. Need for analgetics

    Time frame: instant

  5. Pain during the first 24 hours after coloscopy

    Time frame: 24 hours

  6. Polyp detection rate

    Time frame: instant

Sponsors and collaborators

Lead sponsor

Sorlandet Hospital HF

Other Gov

Registry information

Official study title

Magnetic Endoscopic Imaging Versus Standard Colonoscopy in a Routine Colonoscopy Setting: A Randomised Controlled Trial

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Aug 22, 2007
Registry last updated
Aug 18, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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