Megachannel Device for Advanced Colonoscopy

Medical University of Vienna

Status and phase: Completed; Phase 2

Conditions: Multiple Polyps Right Colon; Suspected Polyp Right Colon; Large Polyp Right Colon

Treatments: Device: Colonoscopy with Megachannel™ device loaded

Study type: Interventional

Funder types: Other

Identifiers

NCT00987896

megachannel

Details and patient eligibility

About

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.

Full 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.

Enrollment: 41 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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41 participants in 1 patient group

Megachannel Application

Experimental group

Description:

Colonoscopy with loaded Megachannel is performed

Treatment:

Device: Colonoscopy with Megachannel™ device loaded