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Exploratory Study of Upper and Lower Endoscopic Fuse System

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02651857
Recruitment Status : Completed
First Posted : January 11, 2016
Last Update Posted : April 28, 2017
Sponsor:
Information provided by (Responsible Party):
EndoChoice Inc.

Study Description
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Brief Summary:
Single-Center, Exploratory Study of EndoChoice's Upper and Lower Gastrointestinal Endoscopic Systems Utilizing EndoChoice's Full Spectrum Optical Technology

Condition or disease Intervention/treatment Phase
Gastrointestinal Diseases Device: Fuse® Colonoscope Device: Fuse® Gastroscope Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Exploratory Study of Upper and Lower Endoscopic Fuse System
Study Start Date : November 2015
Actual Primary Completion Date : April 27, 2017
Study Completion Date : April 27, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Arms and Interventions
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Arm Intervention/treatment
Experimental: Endoscopy exploratory single arm Device: Fuse® Colonoscope
Endoscopic diagnostic procedures for lower GI tract

Device: Fuse® Gastroscope
Endoscopic diagnostic procedures for upper GI tract


Outcome Measures
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Primary Outcome Measures :
  1. Performance, usability and ease of use (performance questionnaire) [ Time Frame: Through study completion, estimate average of 1 year ]
    The performance of the device is assessed via a performance questionnaire which the recruiting (and treatment providing) physician will answer


Secondary Outcome Measures :
  1. Safety (adverse and severe adverse events) [ Time Frame: Through study completion, estimate average of 1 year ]
    Establish safety of the device by measure of adverse and severe adverse events, if such occur.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: EndoChoice Inc.
ClinicalTrials.gov Identifier: NCT02651857    
Other Study ID Numbers: Exploratory study
First Posted: January 11, 2016    Key Record Dates
Last Update Posted: April 28, 2017
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Gastrointestinal Diseases
Digestive System Diseases