Exploratory Study of Upper and Lower Endoscopic Fuse System

Gastrointestinal Diseases Clinical Trial

Official title:

Exploratory Study of Upper and Lower Endoscopic Fuse System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02651857
• Other study ID #: Exploratory study
• Status: Completed
• Phase: N/A
• First received: January 5, 2016
• Last updated: April 27, 2017
• Start date: November 2015
• Est. completion date: April 27, 2017

Study information

• Verified date: January 2016
• Source: EndoChoice Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: April 27, 2017
• Est. primary completion date: April 27, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Digestive System Diseases
• Gastrointestinal Diseases

Intervention

Device:
• Fuse® Colonoscope
Endoscopic diagnostic procedures for lower GI tract
• Fuse® Gastroscope
Endoscopic diagnostic procedures for upper GI tract

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
EndoChoice Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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