A Study of EndoChoice's Upper&Lower Endoscopic Systems Utilizing a Full Spectrum Optical Technology

Study Overview
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Brief Summary
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EndoChoice's FUSE System enables a wider view range via 1-2 additional cameras (depending on the model). These optical properties are to be examined and reviewed in this trial (mainly usability and safety)

Detailed Description
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EndoChoice Full Spectrum Optical Technology (FSOT) in gastrointestinal endoscopy enables a 330 degree field of view. FSOT powers EndoChoice's FDA, CE and AMAR (Israeli medical device authority) approved Endoscopic systems (Gastroscope and Colonoscope). The intent of this study is to evaluate the safety, performance and usability of additional versions of FSOT- powered gastroscopes and colonoscopes.

Official Title
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Single-Center, Exploratory Study of EndoChoice's Upper&Lower Endoscopic Systems Utilizing EndoChoice's Full Spectrum Optical Technology

Conditions
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Gastrointestinal Diseases

Intervention / Treatment
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* Device: Endoscopy exploratory single arm (EndoChoice FUSE(TM) System)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and Female patients ages of 18-70 The patient has been scheduled for routine screening upper or lower endoscopy, diagnostic endoscopic work up, or endoscopic surveillance. Signed informed consent Exclusion Criteria: Patients with inflammatory bowel disease; Patients with a personal history of polyposis syndrome; Patients with suspected bowel stricture potentially precluding complete endoscopy Patients with a history of diverticulitis or toxic megacolon Patients with a history of radiation therapy to neck, abdomen, pelvis; 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 with GI bleeding, that has not been corrected prior to endoscopy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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: Endoscopy exploratory single arm<br>Exploratory single arm, the system will be used in otherwise standard procedures, and will be reviewed in terms of performance, usability, ease of use and safety. | Device: Endoscopy exploratory single arm (EndoChoice FUSE(TM) System)<br>* The investigational device will be applied in otherwise standard procedures (upper and lower Gastrointestinal tract endoscopy)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Performance, usability and ease of use | The performance of the device is assessed via a performance questionnaire which the recruiting (and treatment providing) physician will answer. | 1 Year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety | The safety of the device will be assessed as a secondary outcome measure according to quantity and nature of adverse and severe adverse events, if such occur. | 1 Year |