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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.
The intent of this study is to evaluate the performance and usability of Fuse in routine practice EndoChoice's Fuse system - Fuse is an FDA, CE and AMAR approved Endoscopic system (Gastroscope and Colonoscope).
Fuse® system The Fuse system is intended for diagnostic visualization of the digestive tract. The system also provides access for therapeutic interventions using standard endoscopy tools. The Fuse system consists of camera heads, endoscopes, video system, light source and other ancillary equipment.
Fuse Colonoscopes in conjunction with the FuseBoxâ„¢ processor are indicated for use within the lower digestive tract (including the anus, rectum, sigmoid colon, colon and ileocecal valve) for adult subjects.
Fuse Gastroscopes in conjunction with the FuseBoxâ„¢ processor are indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| open label | Experimental | Upper and Lower digestive tract diagnostic. The Fuse® system is intended for diagnostic visualization of the digestive tract. The system also provides access for therapeutic interventions using standard endoscopy tools. Fuse Colonoscopies are indicated for use within the lower digestive tract (including the anus, rectum, sigmoid colon, colon and ileocecal valve) for adult subjects and for the upper digestive tract (including the esophagus, stomach, and duodenum). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fuse® system | Device | Fuse® system will be used to perform gastro and endoscopic diagnostic procedures for upper and lower GI tract. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of findings (abnormal GI findings, such as polyps and tec.) per diagnostic procedure, using Fuse® system | 1 outpatient hospitalization day for subject |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jacob Dickstein, MD | Carmel Medical Center, Haifa, Israel. | Principal Investigator |
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