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OpenTrials
Completed

NCT Number: NCT00987896

Megachannel Device for Advanced Colonoscopy

Megachannel is a newly developed colonic access system allowing rapid and multiple passes of the colonoscope to the right colon.

The investigators want to conduct a multinational study to evaluate the safety and clinical feasibility of placing a 100 cm Megachannel prototype in the right colon.

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Key information

Conditions

Multiple Polyps Right Colon Large Polyp Right Colon Suspected Polyp Right Colon

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Medical University of Vienna

Vienna, State of Vienna, 1090, Austria

About this study

Patients scheduled for colonoscopy with suspected right colonic polypoid lesions will be included. The prototype will loaded onto a 160 cm lower GI endoscope and introduced via colonoscopic guidance. Time to cecum, total investigation time, clinical feasibility and complications will be recorded.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • patients scheduled for colonoscopy with suspected large or multiple polys in the right colon

Exclusion criteria

  • previous abdominal surgery
  • history or currently diagnosed intra-abdominal cancer
  • patients presenting with unstable angina
  • drug abusers
  • pregnant women
  • patients with known colonic strictures

Treatment and study plan

Colonoscopy with Megachannel™ device loaded

Device

Before colonoscopy, megachannel is loaded on the endoscope, during colonoscopy megachannel will be inserted into the patient via the endoscope placed in the colon

Other names: Megachannel(TM), produced by Minos Medical, Irvine, CA

Primary outcomes

  1. Safety and clinical feasibility of performing colonoscopy with megachannel

    Time frame: during every single colonoscopy in the study

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study title

A Novel Endoscopic Device (Megachannel™) For Repeated Right Colonic Access During Colonoscopy

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Oct 1, 2009
Registry last updated
Oct 1, 2009

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.