Trials / Completed
CompletedNCT02439502
EndoChoice's Fuse® Endoscopic System Performance In Routine Practice
Single Center, Prospective, Open Label Post Marketing Study of EndoChoice's Fuse® Endoscopic System Performance In Routine Practice
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 29 (actual)
- Sponsor
- EndoChoice Innovation Center, Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
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 FuseBox™ 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 FuseBox™ processor are indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Fuse® system | Fuse® system will be used to perform gastro and endoscopic diagnostic procedures for upper and lower GI tract. |
Timeline
- Start date
- 2015-04-01
- Primary completion
- 2016-12-01
- Completion
- 2016-12-01
- First posted
- 2015-05-08
- Last updated
- 2017-01-13
Source: ClinicalTrials.gov record NCT02439502. Inclusion in this directory is not an endorsement.