Back to resultsA Study of EndoChoice's Upper&Lower Endoscopic Systems Utilizing a Full Spectrum Optical Technology (FUSE)
Primary Purpose
Gastrointestinal Diseases
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Endoscopy exploratory single arm (EndoChoice FUSE(TM) System)
Sponsored by
About this trial
This is an interventional diagnostic trial for Gastrointestinal Diseases
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
Sites / Locations
- Rambam medical center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Endoscopy exploratory single arm
Arm 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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT02143284
First Posted
May 5, 2014
Last Updated
November 2, 2016
Sponsor
EndoChoice Innovation Center, Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT02143284
Brief Title
A Study of EndoChoice's Upper&Lower Endoscopic Systems Utilizing a Full Spectrum Optical Technology
Acronym
FUSE
Official Title
Single-Center, Exploratory Study of EndoChoice's Upper&Lower Endoscopic Systems Utilizing EndoChoice's Full Spectrum Optical Technology
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
EndoChoice Innovation Center, Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrointestinal Diseases
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Endoscopy exploratory single arm
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
Endoscopy exploratory single arm (EndoChoice FUSE(TM) System)
Intervention Description
The investigational device will be applied in otherwise standard procedures (upper and lower Gastrointestinal tract endoscopy)
Primary Outcome Measure Information:
Title
Performance, usability and ease of use
Description
The performance of the device is assessed via a performance questionnaire which the recruiting (and treatment providing) physician will answer.
Time Frame
1 Year
Secondary Outcome Measure Information:
Title
Safety
Description
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.
Time Frame
1 Year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ian Gralnek, Prof.
Organizational Affiliation
Rambam Medical Center Gastroenterological institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rambam medical center
City
Haifa
ZIP/Postal Code
31096
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
A Study of EndoChoice's Upper&Lower Endoscopic Systems Utilizing a Full Spectrum Optical Technology
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