Exploratory Study of Upper and Lower Endoscopic Fuse System

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

Study Overview

• Status: Completed
• Conditions: Gastrointestinal Diseases
• Intervention / Treatment: Device: Fuse® Colonoscope; Device: Fuse® Gastroscope

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 Type: Interventional
• Enrollment (Anticipated): 1000
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Endoscopy exploratory single arm	Device: Fuse® Colonoscope; Endoscopic diagnostic procedures for lower GI tract; Device: Fuse® Gastroscope; Endoscopic diagnostic procedures for upper GI tract

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Through study completion, estimate average of 1 year

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: EndoChoice Inc.

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (Actual): April 27, 2017
• Study Completion: April 27, 2017

Study Registration Dates

• First Submitted: January 5, 2016
• First Submitted That Met QC Criteria: January 8, 2016
• First Posted (Estimate): January 11, 2016

Study Record Updates

• Last Update Posted (Actual): April 28, 2017
• Last Update Submitted That Met QC Criteria: April 27, 2017
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Gastrointestinal Diseases; Digestive System Diseases
• Other Study ID Numbers: Exploratory study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED