Megachannel Device for Advanced Colonoscopy

Medical University of Vienna41 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Multiple Polyps Right Colon Large Polyp Right Colon Suspected Polyp Right Colon

Interventions

Colonoscopy with Megachannel™ device loadedDEVICE

Before colonoscopy, megachannel is loaded on the endoscope, during colonoscopy megachannel will be inserted into the patient via the endoscope placed in the colon

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Medical University of Vienna

Vienna, State of Vienna, Austria

Outcomes

Primary Outcomes

Safety and clinical feasibility of performing colonoscopy with megachannel

Time frame: during every single colonoscopy in the study

Data from ClinicalTrials.gov

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