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

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: 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.

Tracking Information
First Submitted Date  ICMJE May 5, 2014
First Posted Date  ICMJE May 21, 2014
Last Update Posted Date November 3, 2016
Study Start Date  ICMJE May 2014
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of EndoChoice's Upper&Lower Endoscopic Systems Utilizing a Full Spectrum Optical Technology
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Gastrointestinal Diseases
Intervention  ICMJE 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  ICMJE 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 2, 2016)
30
Original Estimated Enrollment  ICMJE
 (submitted: May 20, 2014)
280
Actual Study Completion Date  ICMJE January 2015
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02143284
Other Study ID Numbers  ICMJE CD-1715
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party EndoChoice Innovation Center, Ltd.
Study Sponsor  ICMJE EndoChoice Innovation Center, Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ian Gralnek, Prof. Rambam Medical Center Gastroenterological institute
PRS Account EndoChoice Innovation Center, Ltd.
Verification Date November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP