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

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02439502

Acronym

Fuse®

Enrollment

Registered

2015-05-08

Start date

2015-04-30

Completion date

2016-12-31

Last updated

2017-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Miscellaneous Gastroenterology and Urology Devices Associated With Adverse Incidents, Not Elsewhere Classified

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).

Interventions

DEVICEFuse® system

Fuse® system will be used to perform gastro and endoscopic diagnostic procedures for upper and lower GI tract.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Male and female subjects ages 18 at least * The subject has been scheduled for routine screening upper or lower endoscopy, diagnostic work up, or endoscopic surveillance. * Signed informed consent

Exclusion criteria

* Subjects who are currently enrolled in another clinical study

Design outcomes

Primary

Measure	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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026