Trial Outcomes & Findings for BRIDGE Device for Post-operative Pain Control (NCT NCT03265249)

Results Overview

Comparison between study groups (BRIDGE device vs. Standard of Care)

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

27 participants

Primary outcome timeframe

up to day 30

Results posted on

2026-05-29

Participant Flow

Participant milestones

Participant milestones
Measure	BRIDGE Device BRIDGE device will be placed prior to start of the surgery with standard of care pain control analgesia BRIDGE device: 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	Standard of Care Subjects will receive the standard of care pain control analgesia
Overall Study STARTED	12	15
Overall Study COMPLETED	12	14
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	BRIDGE Device BRIDGE device will be placed prior to start of the surgery with standard of care pain control analgesia BRIDGE device: 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	Standard of Care Subjects will receive the standard of care pain control analgesia
Overall Study Withdrawal by Subject	0	1

Baseline Characteristics

BRIDGE Device for Post-operative Pain Control

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	BRIDGE Device n=12 Participants BRIDGE device will be placed prior to start of the surgery with standard of care pain control analgesia BRIDGE device: 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	Standard of Care n=15 Participants Subjects will receive the standard of care pain control analgesia	Total n=27 Participants Total of all reporting groups
Region of Enrollment United States	12 Participants n=51 Participants	15 Participants n=14 Participants	27 Participants n=65 Participants
Age, Continuous	56.81 years STANDARD_DEVIATION 10.17 • n=51 Participants	55.98 years STANDARD_DEVIATION 10.57 • n=14 Participants	56.40 years STANDARD_DEVIATION 10.37 • n=65 Participants
Sex: Female, Male Female	5 Participants n=51 Participants	4 Participants n=14 Participants	9 Participants n=65 Participants
Sex: Female, Male Male	7 Participants n=51 Participants	11 Participants n=14 Participants	18 Participants n=65 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=51 Participants	0 Participants n=14 Participants	1 Participants n=65 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	11 Participants n=51 Participants	15 Participants n=14 Participants	26 Participants n=65 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=51 Participants	0 Participants n=14 Participants	0 Participants n=65 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=51 Participants	0 Participants n=14 Participants	0 Participants n=65 Participants
Race (NIH/OMB) Asian	0 Participants n=51 Participants	0 Participants n=14 Participants	0 Participants n=65 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=51 Participants	0 Participants n=14 Participants	0 Participants n=65 Participants
Race (NIH/OMB) Black or African American	3 Participants n=51 Participants	0 Participants n=14 Participants	3 Participants n=65 Participants
Race (NIH/OMB) White	9 Participants n=51 Participants	15 Participants n=14 Participants	24 Participants n=65 Participants
Race (NIH/OMB) More than one race	0 Participants n=51 Participants	0 Participants n=14 Participants	0 Participants n=65 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=51 Participants	0 Participants n=14 Participants	0 Participants n=65 Participants

PRIMARY outcome

Timeframe: up to day 30

Comparison between study groups (BRIDGE device vs. Standard of Care)

Outcome measures

Outcome measures
Measure	BRIDGE Device n=12 Participants BRIDGE device will be placed prior to start of the surgery with standard of care pain control analgesia BRIDGE device: 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	Standard of Care n=15 Participants Subjects will receive the standard of care pain control analgesia
Opioid Usage After Surgery as Measured by Total Milligrams of Morphine or Equivalent (MEQ)	51.1 milligrams morphine or equivalent (MEQ) Interval 36.6 to 65.6	45.4 milligrams morphine or equivalent (MEQ) Interval 32.4 to 58.3

SECONDARY outcome

Timeframe: up to day 30

Population: Due to the study terminating, no statistical analyses were performed.

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.

Outcome measures

Outcome measures
Measure	BRIDGE Device n=12 Participants BRIDGE device will be placed prior to start of the surgery with standard of care pain control analgesia BRIDGE device: 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	Standard of Care n=15 Participants Subjects will receive the standard of care pain control analgesia
Pain Level	6.6 units on a scale Interval 0.0 to 10.0	5.0 units on a scale Interval 0.0 to 10.0

SECONDARY outcome

Timeframe: up to day 30

Population: Analysis population is participants who completed the PONV surveys and reported nausea at more than one time point.

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.

Outcome measures

Outcome measures
Measure	BRIDGE Device n=1 Participants BRIDGE device will be placed prior to start of the surgery with standard of care pain control analgesia BRIDGE device: 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	Standard of Care n=1 Participants Subjects will receive the standard of care pain control analgesia
Reduction in Nausea Scores as Measured by a 4-item Questionnaire Response 6-12 hours post-op	3 score on a scale	0 score on a scale
Reduction in Nausea Scores as Measured by a 4-item Questionnaire Response 12-24 hours post-op	—	275 score on a scale
Reduction in Nausea Scores as Measured by a 4-item Questionnaire Response 24-48 hours post-op	0 score on a scale	0 score on a scale
Reduction in Nausea Scores as Measured by a 4-item Questionnaire Response Baseline	—	96 score on a scale
Reduction in Nausea Scores as Measured by a 4-item Questionnaire Response Day 30 post-op	—	1 score on a scale

SECONDARY outcome

Timeframe: up to day 30

Population: Due to the study terminating and missing data, no statistical analyses were performed.

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.

Outcome measures

Outcome measures
Measure	BRIDGE Device n=12 Participants BRIDGE device will be placed prior to start of the surgery with standard of care pain control analgesia BRIDGE device: 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	Standard of Care n=15 Participants Subjects will receive the standard of care pain control analgesia
Reduction in Vomiting Scores as Measured by a 4-item Questionnaire Response	2 participants	1 participants

SECONDARY outcome

Timeframe: up to day 5

Population: Analysis population includes participants still on study at return of bowel function

Evaluation of return of bowel function noting day of bowel movement occurrence in both groups.

Outcome measures

Outcome measures
Measure	BRIDGE Device n=12 Participants BRIDGE device will be placed prior to start of the surgery with standard of care pain control analgesia BRIDGE device: 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	Standard of Care n=11 Participants Subjects will receive the standard of care pain control analgesia
Reduction in Time for Return of Bowel Function as Measured by Length to Time of Bowel Functioning Return.	3 Days post-surgery Standard Deviation 1.65	2 Days post-surgery Standard Deviation 1.51

SECONDARY outcome

Timeframe: up to 48 hours

Determination of the presence of an ileus in the two groups (SOC and with device)

Outcome measures

Outcome measures
Measure	BRIDGE Device n=12 Participants BRIDGE device will be placed prior to start of the surgery with standard of care pain control analgesia BRIDGE device: 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	Standard of Care n=15 Participants Subjects will receive the standard of care pain control analgesia
Incidence of Post-operative Ileus Will be Measured by Number of Participants Who Need Nasogastric Decompression for >48 Hours	0 Participants	0 Participants

SECONDARY outcome

Timeframe: up to 30 days

Population: Due to the study terminating and missing data, no statistical analyses were performed.

Determination of mobility with in the two groups (SOC and with device)

Outcome measures

Outcome measures
Measure	BRIDGE Device n=12 Participants BRIDGE device will be placed prior to start of the surgery with standard of care pain control analgesia BRIDGE device: 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	Standard of Care n=15 Participants Subjects will receive the standard of care pain control analgesia
Number of Participants Who Reported Post-operative Mobility Issues as Measured by the Patient Symptom Surveys	2 Participants	7 Participants

SECONDARY outcome

Timeframe: up to 30 days

Determination of length of hospital stay with in the two groups (SOC and with device)

Outcome measures

Outcome measures
Measure	BRIDGE Device n=12 Participants BRIDGE device will be placed prior to start of the surgery with standard of care pain control analgesia BRIDGE device: 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	Standard of Care n=15 Participants Subjects will receive the standard of care pain control analgesia
Average Length of Hospital Stay	7.7 days Interval 4.0 to 13.0	8 days Interval 5.0 to 15.0

SECONDARY outcome

Timeframe: 24 hours after device has been removed

Population: "Physical function" was not clearly defined in the protocol and none of the collected survey data provide that information. Due to the Principal Investigator leaving, the study terminating and undefined data, no data were collected or no data will ever be reported for this outcome, and no statistical analyses were performed.

Time to physical function measured by survey

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 hours after device has been removed

Population: This outcome only applies to the BRIDGE device cohort

Complications related to pain control after the device is removed.

Outcome measures

Outcome measures
Measure	BRIDGE Device n=12 Participants BRIDGE device will be placed prior to start of the surgery with standard of care pain control analgesia BRIDGE device: 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	Standard of Care Subjects will receive the standard of care pain control analgesia
Incidence of Complications	0 Participants	—

SECONDARY outcome

Timeframe: up to 30 days

Outcome measures

Outcome measures
Measure	BRIDGE Device n=12 Participants BRIDGE device will be placed prior to start of the surgery with standard of care pain control analgesia BRIDGE device: 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	Standard of Care n=15 Participants Subjects will receive the standard of care pain control analgesia
Number of Participants Who Were Re-hospitalized	3 Participants	1 Participants

Adverse Events

BRIDGE Device

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard of Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Alisha Mavis, M.D.

Duke University

Phone: 919-684-5068

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place