Exploratory Study of Upper and Lower Endoscopic Fuse System

EndoChoice

Status: Completed

Conditions: Gastrointestinal Diseases

Treatments: Device: Fuse® Colonoscope; Device: Fuse® Gastroscope

Study type: Interventional

Funder types: Industry

Identifiers

NCT02651857

Exploratory study

Details and patient eligibility

About

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

Full 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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

1,000 participants in 1 patient group

Endoscopy exploratory single arm

Experimental group

Treatment:

Device: Fuse® Gastroscope

Device: Fuse® Colonoscope