Gastrointestinal Diseases
Conditions
Brief summary
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
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.
Interventions
DEVICEEndoscopy exploratory single arm (EndoChoice FUSE(TM) System)
The investigational device will be applied in otherwise standard procedures (upper and lower Gastrointestinal tract endoscopy)
Sponsors
EndoChoice Innovation Center, Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Performance, usability and ease of use | 1 Year | The performance of the device is assessed via a performance questionnaire which the recruiting (and treatment providing) physician will answer. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety | 1 Year | 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. |
Countries
Israel
Outcome results
None listed