Skip to main content
OpenTrials
Completed

NCT Number: NCT02439502

EndoChoice's Fuse® Endoscopic System Performance In Routine Practice

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this 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 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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fuse® system

Device

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

Primary outcomes

  1. Number of findings (abnormal GI findings, such as polyps and tec.) per diagnostic procedure, using Fuse® system

    Time frame: 1 outpatient hospitalization day for subject

Sponsors and collaborators

Lead sponsor

EndoChoice Innovation Center, Ltd.

Industry

Registry information

Official study title

Single Center, Prospective, Open Label Post Marketing Study of EndoChoice's Fuse® Endoscopic System Performance In Routine Practice

Acronym: Fuse®

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
May 8, 2015
Registry last updated
Jan 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.