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Sponsor decision
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bridge device | Experimental | The active Bridge device delivers electrical stimulation to the cranial and occipital nerves. |
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| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bridge device | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day of surgery to Day 5 (120 hours) post-op |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15232 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Bridge Device | The active Bridge device delivers electrical stimulation to the cranial and occipital nerves. Bridge device: 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. |
| FG001 | Sham Device | 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 Sham device: 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Bridge Device | The active Bridge device delivers electrical stimulation to the cranial and occipital nerves. Bridge device: 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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. | Posted | Number | doses | Day of surgery to Day 5 (120 hours) post-op |
|
Day of surgery to post-operative day 5
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Bridge Device | The active Bridge device delivers electrical stimulation to the cranial and occipital nerves. Bridge device: 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chelsea Frank | Masimo Corporation | 949-297-7000 | clinicalresearchdept@masimo.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 24, 2022 | Nov 17, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| Sham device | Device | 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. |
|
| 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). | 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. | 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. | Day of surgery to post-operative day 30. |
| Sham Device |
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 Sham device: 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG001 | Sham Device | 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 Sham device: 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. |
|
|
| Secondary | 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). | 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 have been reported. Further data reporting would be statistically inappropriate due to the sample size. | Posted | Number | score on a scale | Day of surgery to Day 5 (120 hours) post-op |
|
|
|
| Secondary | 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). | 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 have been reported. Further data reporting would be statistically inappropriate due to the sample size. | Posted | Number | score on a scale | Day of surgery to Day 5 (120 hours) post-op |
|
|
|
| Secondary | 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. | No data was collected for this outcome measure. 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 have been reported. | Posted | Day of surgery to post-operative day 30. |
|
|
| Secondary | 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. | No data was collected for this outcome measure. 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 have been reported. | Posted | Day of surgery to post-operative day 30. |
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|
| 0 |
| 2 |
| 0 |
| 2 |
| 0 |
| 2 |
| EG001 | Sham Device | 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 Sham device: 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. | 0 | 3 | 0 | 3 | 0 | 3 |
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| 12 hours post-op |
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| 18 hours post-op |
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| Day 1 (24 hours) post-op |
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| Day 2 (48 hours) post-op |
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| Day 3 (72 hours) post-op |
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| Day 4 (96 hours) post-op |
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| Day 5 (120 hours) post-op |
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| 12 hours post-op |
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| 18 hours post-op |
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| Day 1 (24 hours) post-op |
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| Day 2 (48 hours) post-op |
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| Day 3 (72 hours) post-op |
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| Day 4 (96 hours) post-op |
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| Day 5 (120 hours) post-op |
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