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Completed

NCT Number: NCT02143284

A Study of EndoChoice's Upper&Lower Endoscopic Systems Utilizing a Full Spectrum Optical Technology

EndoChoice's FUSE System enables a wider view range via 1-2 additional cameras (depending on the model). These optical properties are to be examined and reviewed in this trial (mainly usability and safety)

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Key information

Conditions

Gastrointestinal Diseases Digestive System Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rambam medical center

Haifa, Israel, 31096

About this study

EndoChoice Full Spectrum Optical Technology (FSOT) in gastrointestinal endoscopy enables a 330 degree field of view. FSOT powers EndoChoice's FDA, CE and AMAR (Israeli medical device authority) approved Endoscopic systems (Gastroscope and Colonoscope). The intent of this study is to evaluate the safety, performance and usability of additional versions of FSOT- powered gastroscopes and colonoscopes.

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 18-70
  • The patient has been scheduled for routine screening upper or lower endoscopy, diagnostic endoscopic work up, or endoscopic surveillance.
  • Signed informed consent

Exclusion criteria

  • Patients with inflammatory bowel disease;
  • Patients with a personal history of polyposis syndrome;
  • Patients with suspected bowel stricture potentially precluding complete endoscopy
  • Patients with a history of diverticulitis or toxic megacolon
  • Patients with a history of radiation therapy to neck, abdomen, pelvis;
  • 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 with GI bleeding, that has not been corrected prior to endoscopy

Treatment and study plan

Endoscopy exploratory single arm (EndoChoice FUSE(TM) System)

Device

The investigational device will be applied in otherwise standard procedures (upper and lower Gastrointestinal tract endoscopy)

Primary outcomes

  1. Performance, usability and ease of use

    Time frame: 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

    Time frame: 1 Year

    The safety of the device will be assessed as a secondary outcome measure according to quantity and nature of adverse and severe adverse events, if such occur.

Sponsors and collaborators

Lead sponsor

EndoChoice Innovation Center, Ltd.

Industry

Registry information

Official study title

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

Acronym: FUSE

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
May 21, 2014
Registry last updated
Nov 3, 2016

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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