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

EndoChoice

Status: Completed

Conditions: Gastrointestinal Diseases

Treatments: Device: Endoscopy exploratory single arm (EndoChoice FUSE(TM) System)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02143284

CD-1715

Details and patient eligibility

About

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)

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Endoscopy exploratory single arm

Experimental group

Description:

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.

Treatment:

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