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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
  Purpose

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: Endpoint Classification: Safety/Efficacy Study
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:

MedlinePlus related topics: Colonoscopy
U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00987896

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

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Arnulf Ferlitsch, MD, Medizinische Universität Wien
ClinicalTrials.gov Identifier: NCT00987896     History of Changes
Other Study ID Numbers: megachannel
Study First Received: September 30, 2009
Last Updated: September 30, 2009
Health Authority: Austria: Federal Ministry for Health and Women

Keywords provided by Medical University of Vienna:
colonoscopy
polypectomy
NOTES

Additional relevant MeSH terms:
Polyps
Colorectal Neoplasms
Nasopharyngeal Neoplasms
Pathological Conditions, Anatomical
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
 Colonic Diseases
Intestinal Diseases
Rectal Diseases
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on May 16, 2013