Megachannel Device for Advanced Colonoscopy
Primary Purpose
Multiple Polyps Right Colon, Large Polyp Right Colon, Suspected Polyp Right Colon
Status
Completed
Phase
Phase 2
Locations
Austria
Study Type
Interventional
Intervention
Colonoscopy with Megachannel™ device loaded
Sponsored by
About this trial
This is an interventional diagnostic trial for Multiple Polyps Right Colon focused on measuring colonoscopy, polypectomy, NOTES
Eligibility 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
Sites / Locations
- Medical University of Vienna
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Megachannel Application
Arm Description
Colonoscopy with loaded Megachannel is performed
Outcomes
Primary Outcome Measures
Safety and clinical feasibility of performing colonoscopy with megachannel
Secondary Outcome Measures
Full Information
NCT ID
NCT00987896
First Posted
September 30, 2009
Last Updated
September 30, 2009
Sponsor
Medical University of Vienna
1. Study Identification
Unique Protocol Identification Number
NCT00987896
Brief Title
Megachannel Device for Advanced Colonoscopy
Official Title
A Novel Endoscopic Device (Megachannel™) For Repeated Right Colonic Access During Colonoscopy
Study Type
Interventional
2. Study Status
Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
October 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Medical University of Vienna
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Polyps Right Colon, Large Polyp Right Colon, Suspected Polyp Right Colon
Keywords
colonoscopy, polypectomy, NOTES
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
41 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Megachannel Application
Arm Type
Experimental
Arm Description
Colonoscopy with loaded Megachannel is performed
Intervention Type
Device
Intervention Name(s)
Colonoscopy with Megachannel™ device loaded
Other Intervention Name(s)
Megachannel(TM), produced by Minos Medical, Irvine, CA
Intervention Description
Before colonoscopy, megachannel is loaded on the endoscope, during colonoscopy megachannel will be inserted into the patient via the endoscope placed in the colon
Primary Outcome Measure Information:
Title
Safety and clinical feasibility of performing colonoscopy with megachannel
Time Frame
during every single colonoscopy in the study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arnulf Ferlitsch, MD
Organizational Affiliation
Medical University of Vienna
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria
12. IPD Sharing Statement
Citations:
PubMed Identifier
18455170
Citation
Silberhumer GR, Birsan T, Noda W, Unger E, Mayr W, Lang S, Prager G, Gasche C. Design and instrumentation of new devices for performing appendectomy at colonoscopy (with video). Gastrointest Endosc. 2008 Jul;68(1):139-45. doi: 10.1016/j.gie.2008.02.024. Epub 2008 May 2.
Results Reference
background
PubMed Identifier
20438892
Citation
Ferlitsch A, Silberhumer GR, Noda W, Birsan T, Desai D, Kumar A, Rao GV, Khakar A, Gomez NA, Gasche C. A novel endoscopic device for repeated right-side colonic access during colonoscopy (with video). Gastrointest Endosc. 2010 May;71(6):1052-5. doi: 10.1016/j.gie.2009.12.059.
Results Reference
derived
Learn more about this trial
Megachannel Device for Advanced Colonoscopy
We'll reach out to this number within 24 hrs