Feasibility of Bridge for Post-Operative Pain Management in Hip Arthroplasty

A study testing Bridge device in people with Pain, Postoperative, run by Masimo Corporation at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

The aim of this research study is to gather data regarding the feasibility of the Bridge system for the management of pain following total hip arthroplasty (THA). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Pain, Postoperative
What is being tested?: Bridge device
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 5 participants
Where: 1 siteUnited States
Study dates: 26 Apr 2022to 24 May 2023
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subject is 18 years of age or older
Subject scheduled for elective primary unilateral total hip arthroplasty (THA)
Subject opioid use is less than 60 milligram morphine equivalent for the last 30 days
Subject has given written informed consent to participate in the study

Who cannot join

Subjects who are pregnant or breastfeeding
Subjects with cardiac pacemakers or other implanted devices (e.g. vagal nerve simulators), hemophilia or psoriasis vulgaris
Subjects with a history of active depression, anxiety or catastrophizing
Subjects with active alcoholism or drug abuse
Subjects with severe chronic pain condition that requires daily preoperative opioid dependence
Subjects deemed not suitable for the study at the discretion of the principal investigator
Subjects who are concurrently participating in any other research study

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15232

Other trials in United States

About this study

The aim of this research study is to gather data regarding the feasibility of the Bridge system for the management of pain following total hip arthroplasty (THA).

Conditions: Pain, Postoperative
Being tested: Bridge device, Sham device
Medical subject headings: Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Bridge deviceDevice
Bridge is a percutaneous nerve field stimulation device which uses alternating currents of stimulation over a large field and with higher voltage in order to influence central pain areas.
Sham deviceDevice
The sham device has the same appearance and will require the same placement technique as the Bridge (active) device but will not deliver electrical impulses.

Study groups in NCT05017701
Study group	Role	What they receive
Bridge device	Experimental	The active Bridge device delivers electrical stimulation to the cranial and occipital nerves. Receives: Device: Bridge device
Sham device	Sham comparator	The sham device has the same appearance and will require the same placement technique as the Bridge (active) device but will not deliver electrical impulses Receives: Device: Sham device

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Total Opioid Consumption Between Active and Sham Arms.
The sample size is well below the threshold needed to reliably assess outcomes and perform statistical comparisons. As a result, we have provided the raw data for comparison of opioid consumption between the two groups.
Measured: Day of surgery to Day 5 (120 hours) post-op

Secondary outcomes (4)

Change in Pain Between Active and Sham Arms as Measured Using the Numeric Rating Scale.
Pain scores using a numerical scale will be collected at rest and movement and will be obtained prior to surgery, in the recovery room, prior to leaving the recovery room, every 6 hours during the first 24 hrs, and at 48, 72, 96 and 120 hours post-operatively. Subjects will use a 0-10 numeric scale (0 indicating no pain and 10 indicating extreme pain).
Measured: Day of surgery to Day 5 (120 hours) post-op
Change in Postoperative Nausea Between Active and Sham Arms as Measured Using a Postoperative Nausea and Vomiting Rating Scale.
Postoperative nausea and vomiting will be evaluated from immediately after surgery through postoperative day 5, using a 0-10 scale (0 indicating no nausea and 10 indicating extreme nausea).
Measured: Day of surgery to Day 5 (120 hours) post-op
Change in Functional Recovery Between Active and Sham Arms Assessed Using the Timed Up and Go (TUG) Assessment Collected on Post-Op Day 30
Functional recovery will be assessed daily from day of surgery to post-op day 5, using the Timed Up and Go assessment to assess mobility.
Measured: Day of surgery to post-operative day 30.
Change in Functional Recovery Between Active and Sham Arms Assessed Using the 12-Item Short Form Survey (SF-12) Collected on Post-Op Day 30
Subjects will also complete the 12-Item Short Form Survey (SF-12) on Post-Op day 30 to evaluate quality of recovery.
Measured: Day of surgery to post-operative day 30.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 Apr 202224 May 2023

First posted24 Aug 2021
Study start26 Apr 2022
Primary completion19 Nov 2022
Study completion24 May 2023

Why it stopped: Sponsor decision

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 Pain, PostoperativeStudies of the same condition, open and under way.
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
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 5 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05017701
Sponsor's protocol ID: CHEL0001
Status last verified: Oct 2025
First submitted: 30 Jul 2021
Last updated: 21 Oct 2025
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Pain, Postoperative trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Feasibility of Bridge for Post-Operative Pain Management in Hip Arthroplasty
ClinicalTrials.gov ID: NCT05017701
Acronym / sponsor ID: CHEL0001
Conditions: Pain, Postoperative
Study type: Interventional
Recruitment status: TerminatedReason stopped: Sponsor decision
Enrolment: 5 participants (actual)
Lead sponsor: Masimo CorporationIndustry (pharma, biotech, devices)
Study start: 26 Apr 2022 (actual)
Primary completion: 19 Nov 2022 (actual)
Study completion: 24 May 2023 (actual)
First posted: 24 Aug 2021 (actual)
Results: Posted 21 Oct 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The aim of this research study is to gather data regarding the feasibility of the Bridge system for the management of pain following total hip arthroplasty (THA).

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Bridge device	Experimental	Device: Bridge deviceThe active Bridge device delivers electrical stimulation to the cranial and occipital nerves.
Sham device	Sham comparator	Device: Sham deviceThe sham device has the same appearance and will require the same placement technique as the Bridge (active) device but will not deliver electrical impulses

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Subject is 18 years of age or older
Subject scheduled for elective primary unilateral total hip arthroplasty (THA)
Subject opioid use is less than 60 milligram morphine equivalent for the last 30 days
Subject has given written informed consent to participate in the study

Key exclusion criteria (7 listed)

Subjects who are pregnant or breastfeeding
Subjects with cardiac pacemakers or other implanted devices (e.g. vagal nerve simulators), hemophilia or psoriasis vulgaris
Subjects with a history of active depression, anxiety or catastrophizing
Subjects with active alcoholism or drug abuse
Subjects with severe chronic pain condition that requires daily preoperative opioid dependence

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 deviceBridge is a percutaneous nerve field stimulation device which uses alternating currents of stimulation over a large field and with higher voltage in order to influence central pain areas.	Device	Bridge device
Sham deviceThe sham device has the same appearance and will require the same placement technique as the Bridge (active) device but will not deliver electrical impulses.	Device	Sham device

Primary outcome

Change in Total Opioid Consumption Between Active and Sham Arms.
Time frame: Day of surgery to Day 5 (120 hours) post-op
The sample size is well below the threshold needed to reliably assess outcomes and perform statistical comparisons. As a result, we have provided the raw data for comparison of opioid consumption between the two groups.

4 secondary outcomes

Change in Pain Between Active and Sham Arms as Measured Using the Numeric Rating Scale.
Time frame: Day of surgery to Day 5 (120 hours) post-op
Change in Postoperative Nausea Between Active and Sham Arms as Measured Using a Postoperative Nausea and Vomiting Rating Scale.
Time frame: Day of surgery to Day 5 (120 hours) post-op
Change in Functional Recovery Between Active and Sham Arms Assessed Using the Timed Up and Go (TUG) Assessment Collected on Post-Op Day 30
Time frame: Day of surgery to post-operative day 30.
Change in Functional Recovery Between Active and Sham Arms Assessed Using the 12-Item Short Form Survey (SF-12) Collected on Post-Op Day 30
Time frame: Day of surgery to post-operative day 30.

Results and safety

Results posted to the registry on 21 Oct 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Bridge Device	2	2
Sham Device	3	3

Primary outcome: Change in Total Opioid Consumption Between Active and Sham Arms.

Time frame: Day of surgery to Day 5 (120 hours) post-op. Number. Unit: doses

Measure	Bridge Device n = 2	Sham Device n = 3
Oxycodone 5mg	1	33
Tramadol 50mg	0	5
Meloxicam 15mg	0	7

Population analysed: The study was terminated prematurely due to sponsor decision, with no clinical rationale for the termination. This was a feasibility study and the test device was deemed "end-of-life" by the manufacturer. Only 5 subjects were enrolled out of the 60 anticipated -2 with active devices and 3 with sham devices. All available demographic and outcome measure data from the limited sample size have been reported. Further data reporting would be statistically inappropriate due to the sample size.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Day of surgery to post-operative day 5. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Bridge Device	0 of 2 (0%)	0 of 2 (0%)	0 of 2
Sham Device	0 of 3 (0%)	0 of 3 (0%)	0 of 3

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

The record lists no contact. Use the official record to reach the sponsor.

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 Pain, Postoperative, run by Masimo Corporation 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 4 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 21 Oct 2025. 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. Some participants in this study may receive a placebo. 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 21 Oct 2025). 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?

Change in Total Opioid Consumption Between Active and Sham Arms. (time frame: Day of surgery to Day 5 (120 hours) post-op). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05017701.

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 21 Oct 2025.