NCT02143284

Brief Summary

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)

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

May 1, 2014

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

May 5, 2014

Completed
16 days until next milestone

First Posted

Study publicly available on registry

May 21, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

November 3, 2016

Status Verified

November 1, 2016

Enrollment Period

8 months

First QC Date

May 5, 2014

Last Update Submit

November 2, 2016

Conditions

Gastrointestinal Diseases

Outcome Measures

Primary Outcomes (1)

  • Performance, usability and ease of use

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

    1 Year

Secondary Outcomes (1)

  • Safety

    1 Year

Study Arms (1)

Endoscopy exploratory single arm

EXPERIMENTAL

Exploratory single arm, the system will be used in otherwise standard procedures, and will be reviewed in terms of performance, usability, ease of use and safety.

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

Interventions

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)

Endoscopy exploratory single arm

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rambam medical center

Haifa, Israel, 31096, Israel

Location

MeSH Terms

Conditions

Gastrointestinal Diseases

Interventions

Drug Delivery Systems

Condition Hierarchy (Ancestors)

Digestive System Diseases

Intervention Hierarchy (Ancestors)

Drug TherapyTherapeutics

Study Officials

  • Ian Gralnek, Prof.

    Rambam Medical Center Gastroenterological institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 5, 2014

First Posted

May 21, 2014

Study Start

May 1, 2014

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

November 3, 2016

Record last verified: 2016-11

Locations

IL(1)