Megachannel Device for Advanced Colonoscopy

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. Identifier: NCT00987896
Recruitment Status : Completed
First Posted : October 1, 2009
Last Update Posted : October 1, 2009
Information provided by:
Medical University of Vienna

Brief Summary:

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 or disease Intervention/treatment Phase
Multiple Polyps Right Colon Large Polyp Right Colon Suspected Polyp Right Colon Device: Colonoscopy with Megachannel™ device loaded Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Novel Endoscopic Device (Megachannel™) For Repeated Right Colonic Access During Colonoscopy
Study Start Date : November 2007
Actual Primary Completion Date : July 2008
Actual Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy
U.S. FDA Resources

Arm Intervention/treatment
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

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

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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

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 identifier (NCT number): NCT00987896

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

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
First Posted: October 1, 2009    Key Record Dates
Last Update Posted: October 1, 2009
Last Verified: September 2009

Keywords provided by Medical University of Vienna:

Additional relevant MeSH terms:
Pathological Conditions, Anatomical