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OpenTrials
Completed

NCT Number: NCT02651857

Exploratory Study of Upper and Lower Endoscopic Fuse System

Single-Center, Exploratory Study of EndoChoice's Upper and Lower Gastrointestinal Endoscopic Systems Utilizing EndoChoice's Full Spectrum Optical Technology

Completed

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Key information

Conditions

Gastrointestinal Diseases Digestive System Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

The investigational devices are EndoChoice gastrointestinal endoscopic systems that are similar in their fit, form, and functions to the corresponding commercially available models with the exception of the EndoChoice's proprietary Optical system that enhances their field of view.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male and Female patients ages of 18-75
  • The patient has been scheduled for routine screening upper or lower endoscopy, diagnostic endoscopic work up, or endoscopic surveillance.
  • Signed informed consent form

Exclusion criteria

  • Patients who are currently enrolled in another clinical investigation in which the intervention might compromise the safety of the patient's participation in this study.
  • Patients who are unable to consent
  • Pregnant female patients of any age.

Treatment and study plan

Fuse® Colonoscope

Device

Endoscopic diagnostic procedures for lower GI tract

Fuse® Gastroscope

Device

Endoscopic diagnostic procedures for upper GI tract

Primary outcomes

  1. Performance, usability and ease of use (performance questionnaire)

    Time frame: Through study completion, estimate average of 1 year

    The performance of the device is assessed via a performance questionnaire which the recruiting (and treatment providing) physician will answer

Secondary outcomes

  1. Safety (adverse and severe adverse events)

    Time frame: Through study completion, estimate average of 1 year

    Establish safety of the device by measure of adverse and severe adverse events, if such occur.

Sponsors and collaborators

Lead sponsor

EndoChoice Inc.

Industry

Registry information

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jan 11, 2016
Registry last updated
Apr 28, 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.

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