Megachannel Device for Advanced Colonoscopy

Phase 2

Completed

• Conditions: Multiple Polyps Right Colon; Large Polyp Right Colon; Suspected Polyp Right Colon
• Interventions: Device: Colonoscopy with Megachannel™ device loaded

• Registration Number: NCT00987896
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2007-11
• Primary Completion: 2008-07
• Study Completion: 2008-10
• Status Verified: 2009-09
• Study First Submitted: 2009-09-30
• Study First Submitted QC: 2009-09-30
• Last Update Submitted: 2009-09-30
• Study First Posted: 2009-10-01
• Last Update Posted: 2009-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Megachannel Application	Colonoscopy with Megachannel™ device loaded	Colonoscopy with loaded Megachannel is performed

Primary Outcome Measures

Name	Time	Method
Safety and clinical feasibility of performing colonoscopy with megachannel	during every single colonoscopy in the study

Trial Locations

Locations (1)

Medical University of Vienna; 🇦🇹 Vienna, Austria