NCT02439502

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Apr 2015

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

April 16, 2015

Completed
22 days until next milestone

First Posted

Study publicly available on registry

May 8, 2015

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

January 13, 2017

Status Verified

January 1, 2017

Enrollment Period

1.7 years

First QC Date

April 16, 2015

Last Update Submit

January 12, 2017

Conditions

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

Outcome Measures

Primary Outcomes (1)

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

    1 outpatient hospitalization day for subject

Study Arms (1)

open label

EXPERIMENTAL

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

Interventions

Fuse® systemDEVICE

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

open label

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Subjects who are currently enrolled in another clinical study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

Study Officials

  • Jacob Dickstein, MD

    Carmel Medical Center, Haifa, Israel.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 16, 2015

First Posted

May 8, 2015

Study Start

April 1, 2015

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

January 13, 2017

Record last verified: 2017-01