Exploratory Study of Upper and Lower Endoscopic Fuse System

Not Applicable

Completed

• Conditions: Gastrointestinal Diseases
• Interventions: Device: Fuse® Colonoscope; Device: Fuse® Gastroscope

• Registration Number: NCT02651857
• Lead Sponsor: EndoChoice Inc.

Brief Summary

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

Detailed Description

The investigational devices are EndoChoice gastrointestinal endoscopic systems that are similar in their fit, form, and functions to the corresponding commercially available models with the exception of the EndoChoice's proprietary Optical system that enhances their field of view.

Study Timeline

• Study Start: 2015-11
• Status Verified: 2016-01
• Study First Submitted: 2016-01-05
• Study First Submitted QC: 2016-01-08
• Study First Posted: 2016-01-11
• Primary Completion: 2017-04-27
• Study Completion: 2017-04-27
• Last Update Submitted: 2017-04-27
• Last Update Posted: 2017-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• Male and Female patients ages of 18-75
• The patient has been scheduled for routine screening upper or lower endoscopy, diagnostic endoscopic work up, or endoscopic surveillance.
• Signed informed consent form

Exclusion Criteria

• Patients who are currently enrolled in another clinical investigation in which the intervention might compromise the safety of the patient's participation in this study.
• Patients who are unable to consent
• Pregnant female patients of any age.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Endoscopy exploratory single arm	Fuse® Colonoscope	-
Endoscopy exploratory single arm	Fuse® Gastroscope	-

Primary Outcome Measures

Name	Time	Method
Performance, usability and ease of use (performance questionnaire)	Through study completion, estimate average of 1 year	The performance of the device is assessed via a performance questionnaire which the recruiting (and treatment providing) physician will answer

Secondary Outcome Measures

Name	Time	Method
Safety (adverse and severe adverse events)	Through study completion, estimate average of 1 year	Establish safety of the device by measure of adverse and severe adverse events, if such occur.