EndoChoice's Fuse® Endoscopic System Performance In Routine Practice
NCT02439502 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 29
Last updated 2017-01-13
Summary
The intent of this study is to evaluate the performance and usability of Fuse in routine practice. The participants are indicated for upper (gastroscopy) and lower (colonoscopy) gastrointestinal endoscopy procedures. The study is open label, prospective and Post Marketing study.
Conditions
- Miscellaneous Gastroenterology and Urology Devices Associated With Adverse Incidents, Not Elsewhere Classified
Interventions
- DEVICE
-
Fuse® system
Fuse® system will be used to perform gastro and endoscopic diagnostic procedures for upper and lower GI tract.
Sponsors & Collaborators
-
EndoChoice Innovation Center, Ltd.
lead INDUSTRY
Principal Investigators
-
Jacob Dickstein, MD · Carmel Medical Center, Haifa, Israel.
Study Design
- Allocation
- NA
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-04-30
- Primary Completion
- 2016-12-31
- Completion
- 2016-12-31
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