Megachannel Device for Advanced Colonoscopy

Large Polyp Right Colon Clinical Trial

Official title:

A Novel Endoscopic Device (Megachannel™) For Repeated Right Colonic Access During Colonoscopy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00987896
• Other study ID #: megachannel
• Status: Completed
• Phase: Phase 2
• First received: September 30, 2009
• Last updated: September 30, 2009
• Start date: November 2007
• Est. completion date: October 2008

Study information

• Verified date: September 2009
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Federal Ministry for Health and Women
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: October 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

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

Intervention

Device:
• 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

Locations

Country	Name	City	State
Austria	Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and clinical feasibility of performing colonoscopy with megachannel		during every single colonoscopy in the study	Yes