Exploratory Study of Upper and Lower Endoscopic Fuse System

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02651857

Enrollment

1000

Registered

2016-01-11

Start date

2015-11-30

Completion date

2017-04-27

Last updated

2017-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastrointestinal Diseases

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.

Interventions

DEVICEFuse® Colonoscope

Endoscopic diagnostic procedures for lower GI tract

DEVICEFuse® Gastroscope

Endoscopic diagnostic procedures for upper GI tract

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026