Back to resultsExploratory Study of Upper and Lower Endoscopic Fuse System
Primary Purpose
Gastrointestinal Diseases
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Fuse® Colonoscope
Fuse® Gastroscope
Sponsored by
About this trial
This is an interventional other trial for Gastrointestinal Diseases
Eligibility Criteria
Inclusion Criteria:
- Male and Female patients ages of 18-75
- The patient has been scheduled for routine screening upper or lower endoscopy, diagnostic endoscopic work up, or endoscopic surveillance.
- Signed informed consent form
Exclusion Criteria:
- 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 who are unable to consent
- Pregnant female patients of any age.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Endoscopy exploratory single arm
Arm Description
Outcomes
Primary Outcome Measures
Performance, usability and ease of use (performance questionnaire)
The performance of the device is assessed via a performance questionnaire which the recruiting (and treatment providing) physician will answer
Secondary Outcome Measures
Safety (adverse and severe adverse events)
Establish safety of the device by measure of adverse and severe adverse events, if such occur.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02651857
Brief Title
Exploratory Study of Upper and Lower Endoscopic Fuse System
Official Title
Exploratory Study of Upper and Lower Endoscopic Fuse System
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
November 2015 (undefined)
Primary Completion Date
April 27, 2017 (Actual)
Study Completion Date
April 27, 2017 (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
EndoChoice Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Single-Center, Exploratory Study of EndoChoice's Upper and Lower Gastrointestinal Endoscopic Systems Utilizing EndoChoice's Full Spectrum Optical Technology
Detailed Description
The investigational devices are EndoChoice gastrointestinal endoscopic systems that are similar in their fit, form, and functions to the corresponding commercially available models with the exception of the EndoChoice's proprietary Optical system that enhances their field of view.
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
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Endoscopy exploratory single arm
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Fuse® Colonoscope
Intervention Description
Endoscopic diagnostic procedures for lower GI tract
Intervention Type
Device
Intervention Name(s)
Fuse® Gastroscope
Intervention Description
Endoscopic diagnostic procedures for upper GI tract
Primary Outcome Measure Information:
Title
Performance, usability and ease of use (performance questionnaire)
Description
The performance of the device is assessed via a performance questionnaire which the recruiting (and treatment providing) physician will answer
Time Frame
Through study completion, estimate average of 1 year
Secondary Outcome Measure Information:
Title
Safety (adverse and severe adverse events)
Description
Establish safety of the device by measure of adverse and severe adverse events, if such occur.
Time Frame
Through study completion, estimate average of 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male and Female patients ages of 18-75
The patient has been scheduled for routine screening upper or lower endoscopy, diagnostic endoscopic work up, or endoscopic surveillance.
Signed informed consent form
Exclusion Criteria:
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 who are unable to consent
Pregnant female patients of any age.
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Exploratory Study of Upper and Lower Endoscopic Fuse System
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