NCT02143284

A Study of EndoChoice's Upper&Lower Endoscopic Systems Utilizing a Full Spectrum Optical Technology

Single-Center, Exploratory Study of EndoChoice's Upper&Lower Endoscopic Systems Utilizing EndoChoice's Full Spectrum Optical Technology

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: EndoChoice Innovation Center, Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

EndoChoice's FUSE System enables a wider view range via 1-2 additional cameras (depending on the model). These optical properties are to be examined and reviewed in this trial (mainly usability and safety)

Detailed description

EndoChoice Full Spectrum Optical Technology (FSOT) in gastrointestinal endoscopy enables a 330 degree field of view. FSOT powers EndoChoice's FDA, CE and AMAR (Israeli medical device authority) approved Endoscopic systems (Gastroscope and Colonoscope). The intent of this study is to evaluate the safety, performance and usability of additional versions of FSOT- powered gastroscopes and colonoscopes.

Conditions

• Gastrointestinal Diseases

Interventions

Type	Name	Description
DEVICE	Endoscopy exploratory single arm (EndoChoice FUSE(TM) System)	The investigational device will be applied in otherwise standard procedures (upper and lower Gastrointestinal tract endoscopy)

Timeline

• Start date: 2014-05-01
• Primary completion: 2015-01-01
• Completion: 2015-01-01
• First posted: 2014-05-21
• Last updated: 2016-11-03

Locations

1 site across 1 country: Israel