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

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

Study Description
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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)

Condition or disease Intervention/treatment Phase
Gastrointestinal Diseases Device: Endoscopy exploratory single arm (EndoChoice FUSE(TM) System) Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Single-Center, Exploratory Study of EndoChoice's Upper&Lower Endoscopic Systems Utilizing EndoChoice's Full Spectrum Optical Technology
Study Start Date : May 2014
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

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
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.
 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)


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02143284


Locations
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Israel
Rambam medical center
Haifa, Israel, 31096
Sponsors and Collaborators
EndoChoice Innovation Center, Ltd.
Investigators
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Principal Investigator: Ian Gralnek, Prof. Rambam Medical Center Gastroenterological institute
More Information
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Responsible Party: EndoChoice Innovation Center, Ltd.
ClinicalTrials.gov Identifier: NCT02143284    
Other Study ID Numbers: CD-1715
First Posted: May 21, 2014    Key Record Dates
Last Update Posted: November 3, 2016
Last Verified: November 2016
Additional relevant MeSH terms:
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Gastrointestinal Diseases
Digestive System Diseases