Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2026-03-03 @ 3:54 PM
Study NCT ID:
NCT02439502
Status:
COMPLETED
Last Update Posted:
2017-01-13
First Post:
2015-04-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
EndoChoice's Fuse® Endoscopic System Performance In Routine Practice
Sponsor:
EndoChoice Innovation Center, Ltd.
Organization:
Study Overview
Official Title:
Single Center, Prospective, Open Label Post Marketing Study of EndoChoice's Fuse® Endoscopic System Performance In Routine Practice
Status:
COMPLETED
Status Verified Date:
2017-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Fuse®
Brief 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).
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).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: