Megachannel Device for Advanced Colonoscopy

This study has been completed.
Sponsor:
Information provided by:
Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT00987896
First received: September 30, 2009
Last updated: NA
Last verified: September 2009
History: No changes posted

September 30, 2009
September 30, 2009
November 2007
July 2008   (final data collection date for primary outcome measure)
Safety and clinical feasibility of performing colonoscopy with megachannel [ Time Frame: during every single colonoscopy in the study ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Megachannel Device for Advanced Colonoscopy
A Novel Endoscopic Device (Megachannel™) For Repeated Right Colonic Access During 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.

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.

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • Multiple Polyps Right Colon
  • Large Polyp Right Colon
  • Suspected Polyp Right Colon
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
Experimental: Megachannel Application
Colonoscopy with loaded Megachannel is performed
Intervention: Device: Colonoscopy with Megachannel™ device loaded

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
41
October 2008
July 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Austria
 
NCT00987896
megachannel
No
Arnulf Ferlitsch, MD, Medizinische Universität Wien
Medical University of Vienna
Not Provided
Principal Investigator: Arnulf Ferlitsch, MD Medical University of Vienna
Medical University of Vienna
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP