Liver FailureBRIDGENCT03265249
BRIDGE Device for Post-operative Pain Control
A study testing BRIDGE device in people with Liver Failure and Liver Diseases, Alcoholic, run by Duke University at 1 site in United States.
Trial summary
Auricular neurostimulation is a potential novel and non-invasive method of pain control following liver transplantation in a growing patient population with the probability of significant impact on economics and morbidity. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Liver Failure, Liver Diseases, Alcoholic, Liver Diseases
- What is being tested?
- BRIDGE device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Feb 2018to 3 Apr 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Auricular Percutaneous Electrical Nerve Field Stimulation (PENFS) Using the BRIDGE Device for Post-Operative Pain Control in Patients Undergoing Liver Transplantation
Auricular neurostimulation is a potential novel and non-invasive method of pain control following liver transplantation in a growing patient population with the probability of significant impact on economics and morbidity. The investigators propose a pilot study to investigate the effects of auricular neurostimulation in patients receiving a liver transplantation. The investigator will investigate the effects of auricular neurostimulation with this novel device and compare it to the current standard of care for pain management following liver transplantation.
Read the detailed description
This is a prospective, randomized study to determine the efficacy of the BRIDGE device in reducing pain and opioid use in patients following liver transplantation. Subjects will be randomized in a 1:1 ration to one of the below groups:
Group 1: BRIDGE device will be placed prior to start of the surgery with standard of care pain control analgesia
Group 2: Subjects will receive the standard of care pain control analgesia
- Conditions
- Liver Failure, Liver Diseases, Alcoholic, Liver Diseases, Pain, Postoperative, Transplant; Failure, Liver, Liver Cirrhosis, Biliary
- Being tested
- BRIDGE device
- Medical subject headings
- Liver Failure, Liver Diseases, Alcoholic, Liver Diseases, Pain, Postoperative, Liver Cirrhosis, Biliary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BRIDGE deviceDevice
an externally placed, FDA-cleared device that delivers percutaneous electrical stimulation with alternating frequencies to branches of cranial nerves (V, VII, IX, and X) through the external ear via a field effect
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | BRIDGE device will be placed prior to start of the surgery with standard of care pain control analgesia Receives: Device: BRIDGE device |
| Group 2 | No intervention | Subjects will receive the standard of care pain control analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid Usage After Surgery as Measured by Total Milligrams of Morphine or Equivalent (MEQ)
Comparison between study groups (BRIDGE device vs. Standard of Care)
Measured: up to day 30
Secondary outcomes (10)
Pain Level
Evaluation of the pain score in the two groups (SOC and with device) at the end of surgery. The Numeric Pain Rating Scale (NPRS) ranges from 0-10, and higher scores indicate greater pain.
Measured: up to day 30
Reduction in Nausea Scores as Measured by a 4-item Questionnaire Response
Determination of the intensity of nausea in the two groups (SOC and with device). Clinically important PONV is defined as a total score ≥50 at any time throughout the study period. Scale is 0 to infinity.
Measured: up to day 30
Reduction in Vomiting Scores as Measured by a 4-item Questionnaire Response
Determination of the intensity of vomiting in the two groups (SOC and with device) using the Simplified Postoperative Nausea and Vomiting Impact Scale, where the choices are: No, Sometimes, Often of most of the time, and All of the time.
Measured: up to day 30
Reduction in Time for Return of Bowel Function as Measured by Length to Time of Bowel Functioning Return.
Evaluation of return of bowel function noting day of bowel movement occurrence in both groups.
Measured: up to day 5
Incidence of Post-operative Ileus Will be Measured by Number of Participants Who Need Nasogastric Decompression for >48 Hours
Determination of the presence of an ileus in the two groups (SOC and with device)
Measured: up to 48 hours
Number of Participants Who Reported Post-operative Mobility Issues as Measured by the Patient Symptom Surveys
Determination of mobility with in the two groups (SOC and with device)
Measured: up to 30 days
Average Length of Hospital Stay
Determination of length of hospital stay with in the two groups (SOC and with device)
Measured: up to 30 days
Time to Physical Function
Time to physical function measured by survey
Measured: 24 hours after device has been removed
Incidence of Complications
Complications related to pain control after the device is removed.
Measured: 24 hours after device has been removed
Number of Participants Who Were Re-hospitalized
Measured: up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2017
- Study start12 Feb 2018
- Primary completion3 Apr 2020
- Study completion3 Apr 2020
Why it stopped: slow enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Liver FailureStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two groups where randomization is either to device or SOC (standard of care)
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alicia Mavis, MD, Principal investigator, Duke Universtity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03265249
- Sponsor's protocol ID
- Pro00084620
- Acronym
- BRIDGE
- Status last verified
- Jan 2023
- First submitted
- 22 Aug 2017
- Last updated
- 29 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Auricular Percutaneous Electrical Nerve Field Stimulation (PENFS) Using the BRIDGE Device for Post-Operative Pain Control in Patients Undergoing Liver Transplantation
- ClinicalTrials.gov ID
- NCT03265249
- Acronym / sponsor ID
- BRIDGE / Pro00084620
- Conditions
- Liver Failure, Liver Diseases, Alcoholic, Liver Diseases, Pain, Postoperative, Transplant; Failure, Liver, Liver Cirrhosis, Biliary
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: slow enrollment
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 12 Feb 2018 (actual)
- Primary completion
- 3 Apr 2020 (actual)
- Study completion
- 3 Apr 2020 (actual)
- First posted
- 29 Aug 2017 (actual)
- Results
- Posted 8 Mar 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Auricular neurostimulation is a potential novel and non-invasive method of pain control following liver transplantation in a growing patient population with the probability of significant impact on economics and morbidity. The investigators propose a pilot study to investigate the effects of auricular neurostimulation in patients receiving a liver transplantation. The investigator will investigate the effects of auricular neurostimulation with this novel device and compare it to the current standard of care for pain management following liver transplantation.
Detailed description
This is a prospective, randomized study to determine the efficacy of the BRIDGE device in reducing pain and opioid use in patients following liver transplantation. Subjects will be randomized in a 1:1 ration to one of the below groups:
Group 1: BRIDGE device will be placed prior to start of the surgery with standard of care pain control analgesia
Group 2: Subjects will receive the standard of care pain control analgesia
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two groups where randomization is either to device or SOC (standard of care)
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Device: BRIDGE deviceBRIDGE device will be placed prior to start of the surgery with standard of care pain control analgesia |
| Group 2 | No intervention | –Subjects will receive the standard of care pain control analgesia |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BRIDGE devicean externally placed, FDA-cleared device that delivers percutaneous electrical stimulation with alternating frequencies to branches of cranial nerves (V, VII, IX, and X) through the external ear via a field effect | Device | Group 1 |
Primary outcome
Opioid Usage After Surgery as Measured by Total Milligrams of Morphine or Equivalent (MEQ)
Time frame: up to day 30
Comparison between study groups (BRIDGE device vs. Standard of Care)
10 secondary outcomes
Pain Level
Time frame: up to day 30
Reduction in Nausea Scores as Measured by a 4-item Questionnaire Response
Time frame: up to day 30
Reduction in Vomiting Scores as Measured by a 4-item Questionnaire Response
Time frame: up to day 30
Reduction in Time for Return of Bowel Function as Measured by Length to Time of Bowel Functioning Return.
Time frame: up to day 5
Incidence of Post-operative Ileus Will be Measured by Number of Participants Who Need Nasogastric Decompression for >48 Hours
Time frame: up to 48 hours
Number of Participants Who Reported Post-operative Mobility Issues as Measured by the Patient Symptom Surveys
Time frame: up to 30 days
Average Length of Hospital Stay
Time frame: up to 30 days
Time to Physical Function
Time frame: 24 hours after device has been removed
Incidence of Complications
Time frame: 24 hours after device has been removed
Number of Participants Who Were Re-hospitalized
Time frame: up to 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Liver Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alicia Mavis, MD principal investigator
Duke Universtity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BRIDGE device in people with Liver Failure and Liver Diseases, Alcoholic, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Opioid Usage After Surgery as Measured by Total Milligrams of Morphine or Equivalent (MEQ) (time frame: up to day 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026.