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

Gastrointestinal Diseases Clinical Trial

— FUSE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02143284
• Other study ID #: CD-1715
• Status: Completed
• Phase: N/A
• First received: May 5, 2014
• Last updated: November 2, 2016
• Start date: May 2014
• Est. completion date: January 2015

Study information

• Verified date: November 2016
• Source: EndoChoice Innovation Center, Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Digestive System Diseases
• Gastrointestinal Diseases

Intervention

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)

Locations

Country	Name	City	State
Israel	Rambam medical center	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
EndoChoice Innovation Center, Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	Yes