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
|Condition or disease||Intervention/treatment||Phase|
|Gastrointestinal Diseases||Device: Endoscopy exploratory single arm (EndoChoice FUSE(TM) System)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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)
- 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.
- 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.
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
|Rambam medical center|
|Haifa, Israel, 31096|
|Principal Investigator:||Ian Gralnek, Prof.||Rambam Medical Center Gastroenterological institute|