Trial Outcomes & Findings for BRIDGE Device for Post-operative Pain Control (NCT NCT03265249)
NCT ID: NCT03265249
Last Updated: 2023-03-08
Results Overview
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
27 participants
Primary outcome timeframe
up to day 30
Results posted on
2023-03-08
Participant Flow
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
| 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
| 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
|
|---|---|---|---|
|
Age, Continuous
|
56.81 years
STANDARD_DEVIATION 10.17 • n=99 Participants
|
55.98 years
STANDARD_DEVIATION 10.57 • n=107 Participants
|
56.40 years
STANDARD_DEVIATION 10.37 • n=206 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
12 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: up to day 30Outcome 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 30Evaluation of the pain score in the two groups (SOC and with device) at the end of surgery
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to day 30Determination of the intensity of nausea in the two groups (SOC and with device)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to day 30Determination of the intensity of vomiting in the two groups (SOC and with device)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to day 30Evaluation of return of bowel function noting day of bowel movement occurrence in both groups.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 30 daysDetermination of the presence of an ileus in the two groups (SOC and with device)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 30 daysDetermination of mobility with in the two groups (SOC and with device)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 30 daysDetermination of length of hospital stay with in the two groups (SOC and with device)
Outcome measures
Outcome data not reported
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place