Exploratory Study of Upper and Lower Endoscopic Fuse System

EndoChoice Inc.1,000 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

1,000

Conditions

Gastrointestinal Diseases

Interventions

Fuse® ColonoscopeDEVICE

Endoscopic diagnostic procedures for lower GI tract

Fuse® GastroscopeDEVICE

Endoscopic diagnostic procedures for upper GI tract

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Performance, usability and ease of use (performance questionnaire)

The performance of the device is assessed via a performance questionnaire which the recruiting (and treatment providing) physician will answer

Time frame: Through study completion, estimate average of 1 year

Secondary Outcomes

Safety (adverse and severe adverse events)

Establish safety of the device by measure of adverse and severe adverse events, if such occur.

Time frame: Through study completion, estimate average of 1 year

Data from ClinicalTrials.gov

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