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EndoChoice's Fuse® Endoscopic System Performance In Routine Practice (Fuse®)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02439502
Recruitment Status : Completed
First Posted : May 8, 2015
Last Update Posted : January 13, 2017
Sponsor:
Information provided by (Responsible Party):
EndoChoice Innovation Center, Ltd.

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.

Condition or disease Intervention/treatment Phase
Miscellaneous Gastroenterology and Urology Devices Associated With Adverse Incidents, Not Elsewhere Classified Device: Fuse® system Phase 4

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Single Center, Prospective, Open Label Post Marketing Study of EndoChoice's Fuse® Endoscopic System Performance In Routine Practice
Study Start Date : April 2015
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Arm Intervention/treatment
Experimental: open label
Upper and Lower digestive tract diagnostic. The Fuse® system is intended for diagnostic visualization of the digestive tract. The system also provides access for therapeutic interventions using standard endoscopy tools. Fuse Colonoscopies are indicated for use within the lower digestive tract (including the anus, rectum, sigmoid colon, colon and ileocecal valve) for adult subjects and for the upper digestive tract (including the esophagus, stomach, and duodenum).
Device: Fuse® system
Fuse® system will be used to perform gastro and endoscopic diagnostic procedures for upper and lower GI tract.




Primary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02439502


Sponsors and Collaborators
EndoChoice Innovation Center, Ltd.
Investigators
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Principal Investigator: Jacob Dickstein, MD Carmel Medical Center, Haifa, Israel.
Additional Information:
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Responsible Party: EndoChoice Innovation Center, Ltd.
ClinicalTrials.gov Identifier: NCT02439502    
Other Study ID Numbers: CD 1978
First Posted: May 8, 2015    Key Record Dates
Last Update Posted: January 13, 2017
Last Verified: January 2017