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

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

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)

Study Overview

• Status: Completed
• Conditions: Gastrointestinal Diseases
• Intervention / Treatment: Device: Endoscopy exploratory single arm (EndoChoice FUSE(TM) System)

Detailed Description

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
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Haifa, Israel, 31096
    • Rambam Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: Endoscopy exploratory single arm (EndoChoice FUSE(TM) System); The investigational device will be applied in otherwise standard procedures (upper and lower Gastrointestinal tract endoscopy)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: EndoChoice Innovation Center, Ltd.
• Investigators: Principal Investigator: Ian Gralnek, Prof., Rambam Medical Center Gastroenterological institute

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Actual): January 1, 2015
• Study Completion (Actual): January 1, 2015

Study Registration Dates

• First Submitted: May 5, 2014
• First Submitted That Met QC Criteria: May 20, 2014
• First Posted (Estimate): May 21, 2014

Study Record Updates

• Last Update Posted (Estimate): November 3, 2016
• Last Update Submitted That Met QC Criteria: November 2, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Gastrointestinal Diseases; Digestive System Diseases
• Other Study ID Numbers: CD-1715