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Ear device aims to cut opioid use after liver transplant

NCT ID NCT03265249

Symptom relief Sponsor: Duke University 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a small device worn on the ear that uses mild electrical pulses to help control pain after a liver transplant. The goal was to see if it could reduce the need for strong painkillers like opioids. The study was stopped early and included 27 adults waiting for a liver transplant.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

27 people

The number who actually took part.

Started

Feb 2018

Finished

Apr 2020

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 to 70 years

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: * Inclusion criteria: * ≥18 years of age but \<70 years of age * Actively listed for isolated liver transplantation * Subject or legally authorized representative able to sign informed consent * Not currently treated with opioids or any medications that may interact with opioids * English speaking * Willing and able to participate and consent to this study Exclusion Criteria: * Diagnosis of acute liver failure or primary sclerosing cholangitis (PSC) * Anticipated that the subject will require a new roux-en-y hepaticojejunostomy * Current use of opioid use or other substance abuse. * Chronic pain disorders * Need for regional anesthesia (regional nerve blocks or epidurals) * Adhesive allergy/sensitivity * Subject admitted to the ICU at the time of transplant

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Conditions

The condition(s) this trial relates to.

alcoholic liver disease liver disorder liver failure Pain, Postoperative primary biliary cholangitis

As listed by the trial registrant

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

Liver cirrhosis, biliary Liver diseases Liver diseases, alcoholic Liver failure Pain, postoperative Transplant; failure, liver

Contacts and locations

Locations

  • Duke University

    Durham, North Carolina, 27705, United States

More trials for these conditions

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