NCT04415294

Brief Summary

There is a great unmet clinical need for improved screening for MHE in patients with cirrhosis. We will demonstrate that the Flicker-App can be used in clinic as well as at home by patients with cirrhosis to measure CFF, a proven screening test for MHE. We will optimize the protocol, software, and hardware of the Flicker-App to create a product appropriate for production and distribution to patients

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
75

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2019

Typical duration for all trials

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

October 22, 2019

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 29, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 4, 2020

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

January 11, 2022

Status Verified

January 1, 2022

Enrollment Period

3.6 years

First QC Date

May 29, 2020

Last Update Submit

January 7, 2022

Conditions

Hepatic Encephalopathy

Outcome Measures

Primary Outcomes (1)

  • CFF Agreement

    Level of agreement between Flicker App CFF and gold-standard device

    1 day

Interventions

Critical flicker frequencyDIAGNOSTIC_TEST

Measure the critical flicker frequency as a screening test for hepatic encephalopathy using a portable self administered device

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Cirrhosis patients without Grade III or IV OHE

You may qualify if:

  • Cirrhosis (standard criteria)
  • Chronic liver disease

You may not qualify if:

  • Grade III or IV hepatic encephalopathy
  • Mini-mental state examination score ≤25 (suggestive of dementia)
  • alcohol or illicit drug use within 3 months
  • current use of benzodiazepines
  • antiepileptics or psychotropic drugs
  • color blindness
  • severe vision impairment (blindness, macular degeneration).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Washington Medical Center

Seattle, Washington, 98104, United States

RECRUITING

MeSH Terms

Conditions

Hepatic Encephalopathy

Condition Hierarchy (Ancestors)

Liver FailureHepatic InsufficiencyLiver DiseasesDigestive System DiseasesBrain Diseases, MetabolicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • George N Ioannou, MD, MS

    University of Washington

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Yacoub

CONTACT

2067443402yacoum@washington.medicine.edu

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, School of Medicine

Study Record Dates

First Submitted

May 29, 2020

First Posted

June 4, 2020

Study Start

October 22, 2019

Primary Completion

May 31, 2023

Study Completion

June 30, 2023

Last Updated

January 11, 2022

Record last verified: 2022-01

Locations

US(1)