Megachannel Device for Advanced Colonoscopy

NCT ID: NCT00987896

Last Updated: 2009-10-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-11-30
• Study Completion Date: 2008-10-31

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Megachannel Application

Colonoscopy with loaded Megachannel is performed

Group Type: EXPERIMENTAL

Colonoscopy with Megachannel™ device loaded

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: DEVICE

Other Intervention Names

Megachannel(TM), produced by Minos Medical, Irvine, CA

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Vienna

OTHER

Sponsor Role: lead

Responsible Party

Medizinische Universität Wien

Principal Investigators

Arnulf Ferlitsch, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Vienna

Locations

Medical University of Vienna

Vienna, Vienna, Austria

Countries

Austria

References

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.

Reference Type: BACKGROUND

PMID: 18455170 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 20438892 (View on PubMed)

Other Identifiers

megachannel

Identifier Type: -

Identifier Source: org_study_id