EndoChoice's Fuse® Endoscopic System Performance In Routine Practice

Study Overview
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Brief Summary
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The intent of this study is to evaluate the performance and usability of Fuse in routine practice. The participants are indicated for upper (gastroscopy) and lower (colonoscopy) gastrointestinal endoscopy procedures. The study is open label, prospective and Post Marketing study.

Detailed Description
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The intent of this study is to evaluate the performance and usability of Fuse in routine practice EndoChoice's Fuse system - Fuse is an FDA, CE and AMAR approved Endoscopic system (Gastroscope and Colonoscope). Fuse® system The Fuse system is intended for diagnostic visualization of the digestive tract. The system also provides access for therapeutic interventions using standard endoscopy tools. The Fuse system consists of camera heads, endoscopes, video system, light source and other ancillary equipment. Fuse Colonoscopes in conjunction with the FuseBox™ processor are indicated for use within the lower digestive tract (including the anus, rectum, sigmoid colon, colon and ileocecal valve) for adult subjects. Fuse Gastroscopes in conjunction with the FuseBox™ processor are indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum).

Official Title
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Single Center, Prospective, Open Label Post Marketing Study of EndoChoice's Fuse® Endoscopic System Performance In Routine Practice

Conditions
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Miscellaneous Gastroenterology and Urology Devices Associated With Adverse Incidents, Not Elsewhere Classified

Intervention / Treatment
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* Device: Fuse® system


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female subjects ages 18 at least The subject has been scheduled for routine screening upper or lower endoscopy, diagnostic work up, or endoscopic surveillance. Signed informed consent Exclusion Criteria: Subjects who are currently enrolled in another clinical study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: open label<br>Upper and Lower digestive tract diagnostic. The Fuse® system is intended for diagnostic visualization of the digestive tract. The system also provides access for therapeutic interventions using standard endoscopy tools. Fuse Colonoscopies are indicated for use within the lower digestive tract (including the anus, rectum, sigmoid colon, colon and ileocecal valve) for adult subjects and for the upper digestive tract (including the esophagus, stomach, and duodenum). | Device: Fuse® system<br>* Fuse® system will be used to perform gastro and endoscopic diagnostic procedures for upper and lower GI tract.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of findings (abnormal GI findings, such as polyps and tec.) per diagnostic procedure, using Fuse® system |  | 1 outpatient hospitalization day for subject |