Overview

This trial is active, not recruiting.

Condition gastrointestinal diseases
Treatments fuse® colonoscope, fuse® gastroscope
Sponsor EndoChoice Inc.
Start date November 2015
End date November 2018
Trial size 1000 participants
Trial identifier NCT02651857, Exploratory study

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Arm
(Experimental)
fuse® colonoscope
Endoscopic diagnostic procedures for lower GI tract
fuse® gastroscope
Endoscopic diagnostic procedures for upper GI tract

Primary Outcomes

Measure
Performance, usability and ease of use (performance questionnaire)
time frame: Through study completion, estimate average of 1 year

Secondary Outcomes

Measure
Safety (adverse and severe adverse events)
time frame: Through study completion, estimate average of 1 year

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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.

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by EndoChoice Inc..