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Megachannel Device for Advanced Colonoscopy

This study has been completed.
Information provided by:
Medical University of Vienna Identifier:
First received: September 30, 2009
Last updated: NA
Last verified: September 2009
History: No changes posted

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.

Condition Intervention Phase
Multiple Polyps Right Colon Large Polyp Right Colon Suspected Polyp Right Colon Device: Colonoscopy with Megachannel™ device loaded Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: A Novel Endoscopic Device (Megachannel™) For Repeated Right Colonic Access During Colonoscopy

Resource links provided by NLM:

Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • Safety and clinical feasibility of performing colonoscopy with megachannel [ Time Frame: during every single colonoscopy in the study ]

Enrollment: 41
Study Start Date: November 2007
Study Completion Date: October 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Megachannel Application
Colonoscopy with loaded Megachannel is performed
Device: Colonoscopy with Megachannel™ device loaded
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 Name: Megachannel(TM), produced by Minos Medical, Irvine, CA

Detailed Description:
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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00987896

Medical University of Vienna
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
Principal Investigator: Arnulf Ferlitsch, MD Medical University of Vienna
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Arnulf Ferlitsch, MD, Medizinische Universität Wien Identifier: NCT00987896     History of Changes
Other Study ID Numbers: megachannel
Study First Received: September 30, 2009
Last Updated: September 30, 2009

Keywords provided by Medical University of Vienna:

Additional relevant MeSH terms:
Pathological Conditions, Anatomical processed this record on August 16, 2017