NCT02415348

Brief Summary

This study is designed to determine if the Fibroscan (Echosens, Paris), a non-invasive, ultrasound-based device used to estimate fibrosis in patients with chronic liver disease, interferes with implanted cardiac pacemaker and/or implantable cardioverter-defibrillators. Recruitment consists of a total of 200 outpatients undergoing routine pacemaker interrogation at a teaching-hospital pacemaker clinic.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2015

Geographic Reach
1 country

1 active site

Status
unknown

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
7 days until next milestone

First Submitted

Initial submission to the registry

April 8, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 14, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

May 17, 2016

Status Verified

May 1, 2016

Enrollment Period

1.3 years

First QC Date

April 8, 2015

Last Update Submit

May 13, 2016

Conditions

Liver Cirrhosis

Outcome Measures

Primary Outcomes (2)

  • Rate of Pacemaker/ICD malfunction

    30 min

  • Type of Pacemaker/ICD malfunction

    30 min

Study Arms (1)

Fibroscan

EXPERIMENTAL

Fibroscan under simultaneous cardiac monitoring

Device: Fibroscan

Interventions

FibroscanDEVICE
Fibroscan

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Any outpatient undergoing routine pacemaker interrogation at pacemaker clinic

You may not qualify if:

  • Pregnancy
  • BMI\>35
  • Person with active implantable medical devices other than cardiac pacemaker and/or ICD
  • Person who are unable to tolerate lying flat for the FibroScan examination.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal University Hospital

Saskatoon, Saskatchewan, S7N 0W8, Canada

Location

MeSH Terms

Conditions

Liver Cirrhosis

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Lawrence Worobetz, MD

    University of Saskatchewan

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

April 8, 2015

First Posted

April 14, 2015

Study Start

April 1, 2015

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

May 17, 2016

Record last verified: 2016-05

Locations

CA(1)