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

• ClinicalTrials.gov Identifier: NCT02143284
• Recruitment Status: Completed
• First Posted: May 21, 2014
• Last Update Posted: November 3, 2016
• Sponsor: EndoChoice Innovation Center, Ltd.
• Information provided by (Responsible Party): EndoChoice Innovation Center, Ltd.

Tracking Information

• First Submitted Date: May 5, 2014
• First Posted Date: May 21, 2014
• Last Update Posted Date: November 3, 2016
• Study Start Date: May 2014
• Actual Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 20, 2014)

Performance, usability and ease of use [ Time Frame: 1 Year ]

The performance of the device is assessed via a performance questionnaire which the recruiting (and treatment providing) physician will answer.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: May 20, 2014)

Safety [ Time Frame: 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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study of EndoChoice's Upper&Lower Endoscopic Systems Utilizing a Full Spectrum Optical Technology
• Official Title: Single-Center, Exploratory Study of EndoChoice's Upper&Lower Endoscopic Systems Utilizing EndoChoice's Full Spectrum Optical Technology
• 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.
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Diagnostic
• Condition: 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)

Study Arms

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.

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

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: November 2, 2016): 30
• Original Estimated Enrollment (submitted: May 20, 2014): 280
• Actual Study Completion Date: January 2015
• Actual Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Israel

Administrative Information

• NCT Number: NCT02143284
• Other Study ID Numbers: CD-1715
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: EndoChoice Innovation Center, Ltd.
• Study Sponsor: EndoChoice Innovation Center, Ltd.
• Collaborators: Not Provided

Investigators

• Principal Investigator: Ian Gralnek, Prof.; Rambam Medical Center Gastroenterological institute

• PRS Account: EndoChoice Innovation Center, Ltd.
• Verification Date: November 2016