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

EndoChoice Innovation Center, Ltd.30 enrolled

Overview

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)

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Gastrointestinal Diseases

Interventions

Endoscopy exploratory single arm (EndoChoice FUSE(TM) System)DEVICE

The investigational device will be applied in otherwise standard procedures (upper and lower Gastrointestinal tract endoscopy)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

Rambam medical center

Haifa, Israel, Israel

Outcomes

Primary Outcomes

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.

Time frame: 1 Year

Secondary Outcomes

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.

Time frame: 1 Year

Data from ClinicalTrials.gov

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