Exploratory Study of Upper and Lower Endoscopic Fuse System

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2017-04-27

Brief Summary

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

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Detailed Description

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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.

Conditions

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Gastrointestinal Diseases

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Endoscopy exploratory single arm

Group Type EXPERIMENTAL

Fuse® Colonoscope

Intervention Type DEVICE

Endoscopic diagnostic procedures for lower GI tract

Fuse® Gastroscope

Intervention Type DEVICE

Endoscopic diagnostic procedures for upper GI tract

Interventions

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Fuse® Colonoscope

Endoscopic diagnostic procedures for lower GI tract

Intervention Type DEVICE

Fuse® Gastroscope

Endoscopic diagnostic procedures for upper GI tract

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No