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Can a home device keep cirrhosis patients out of the hospital?

NCT ID NCT02457988

Disease control Sponsor: University of California, Los Angeles Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether a home monitoring kit (measuring blood pressure, weight, and pulse) plus care coordination could reduce hospital readmissions in people with cirrhosis. It enrolled 120 patients with serious complications like fluid buildup or confusion. The trial was terminated early, so the findings are limited.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Vivify Kit (home telemonitoring device)
What this could lead to
If successful, this approach could help manage cirrhosis at home and reduce hospital readmissions.
What could go wrong
The trial was terminated early, so results are limited. It is a small, early-phase study, and the device may not work for everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

About 120 people

The number the study aims to enrol. It can still change while the study runs.

Start date

Apr 2015

Finished

Oct 2017

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Ascites requiring paracentesis during the hospitalization 2. Hepatic encephalopathy defined as altered mental status that improves after treatment with lactulose 3. Variceal hemorrhage, defined as clinically significant gastrointestinal bleed (tachycardia, hypotension, requirement for blood transfusion, or \>2g drop in hemoglobin) and varices seen on endoscopy 4. Spontaneous bacterial peritonitis defined as \>250 polymorphonuclear cells per high-power field and/or monomicrobial culture in the ascetic fluid 5. Renal failure in the presence of ascites, defined as a rise in the serum creatinine by 0.5mg/dl (to \>1.5mg/dl), with ascites documented on physical exam or ultrasound, or admitted on diuretics for the treatment of ascites 6. Hyponatremia, defined by serum sodium \<130 on admission labs 7. Hepatocellular carcinoma as seen on arterial phase MRI or liver biopsy, if tumor is treated and fits within Milan criteria Exclusion Criteria: * Admissions for scheduled or elective procedures * Patients with a comorbid conditions with a life expectancy of less than 12 months or ones that may confound a patient's clinical course * Hepatocellular carcinoma * Hepatorenal syndrome * Hepatopulmonary syndrome * Metastatic cancer * Chronic kidney disease (pre-dialysis, dialysis) * Congestive heart failure * Diagnosed dementia * HIV/AIDS * Pregnancy or planned pregnancy during the study * Those managed by palliative care * Patients with liver transplants prior to or during the index hospitalization * Patients unable to understand study procedures/instructions/use of the home monitoring device * Patients unable to stand for \<1 minute * Patients living in nursing homes or similar institutions

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Conditions

The condition(s) this trial relates to.

cirrhosis of liver Fibrosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cirrhosis

Contacts and locations

Locations

  • UCLA Center for Inflammatory Bowel Diseases

    Los Angeles, California, 90095, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.