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

NCT ID: NCT02143284

Last Updated: 2016-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2015-01-31

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.

Conditions

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Gastrointestinal Diseases

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Endoscopy exploratory single arm

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.

Group Type EXPERIMENTAL

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

Intervention Type DEVICE

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

Interventions

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

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

Intervention Type DEVICE

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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EndoChoice Innovation Center, Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ian Gralnek, Prof.

Role: PRINCIPAL_INVESTIGATOR

Rambam Medical Center Gastroenterological institute

Locations

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Rambam medical center

Haifa, Israel, Israel

Site Status

Countries

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Israel

Other Identifiers

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CD-1715

Identifier Type: -

Identifier Source: org_study_id