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The study is an open-label, non-controlled study of the safety and effectiveness of investigator determined Provant therapy in subjects with pain and/or edema from various pain etiologies. Information collected in the study will be entered into a registry database.
This is an open-label, non-controlled trial in subjects with various pain etiologies at multiple centers in the US. Eligible subjects will include those ≥ 22 years of age that have been deemed appropriate for treatment with Provant by the study investigator (prescriber). Subjects will treat based on the treatment prescribed (location, frequency, duration) by the study investigator.
Data from assessments administered as part of standard of practice will be obtained at baseline and, at a minimum, at the end of treatment. If the investigator administers additional assessments during the course of treatment, the data will be collected.
Safety will be assessed during office visits and through review of AE reports and concomitant treatments and medications. All concomitant drug or non-drug treatments used during the study will be recorded.
Information collected in the study will be entered into a registry database.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Treatment Arm | Experimental | Treatment with Provant Therapy System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Provant Therapy System | Device | Treatment with the Provant Therapy System |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain Intensity Assessment | Change in Pain from Baseline/Pre-treatment to End of Treatment/Last Available Observation. Pain captured using NPRS, 0-10 scale were 0 = no pain and 10 = worst pain, given to subjects as part of a daily diary. | Pain scores collected daily, up to 20 weeks. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AOC-Research, LLC | Birmingham | Alabama | 35209 | United States | ||
| Coolbody Contours |
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| ID | Title | Description |
|---|---|---|
| FG000 | Active Treatment Arm | Treatment with Provant Therapy System Provant Therapy System: Treatment with the Provant Therapy System |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Active Treatment Arm | Treatment with Provant Therapy System Provant Therapy System: Treatment with the Provant Therapy System |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Pain Intensity Assessment | Change in Pain from Baseline/Pre-treatment to End of Treatment/Last Available Observation. Pain captured using NPRS, 0-10 scale were 0 = no pain and 10 = worst pain, given to subjects as part of a daily diary. | Subjects recording both a Baseline and End of Study score were included in the NPRS analysis. | Posted | Mean | Standard Deviation | score on a scale | Pain scores collected daily, up to 20 weeks. |
|
|
Through end of treatment, up to 20 weeks.
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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 | Active Treatment Arm | Treatment with Provant Therapy System Provant Therapy System: Treatment with the Provant Therapy System |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Operations Manager | Regenesis Biomedical | 602-428-7041 | heather.vanderploeg@regenesisbio.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol: Study Protocol | Jan 18, 2017 | Apr 2, 2020 | Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 30, 2016 | Apr 3, 2020 | SAP_003.pdf |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Scottsdale |
| Arizona |
| 85251 |
| United States |
| Scottsdale Center for Women's Health | Scottsdale | Arizona | 85258 | United States |
| Coastal Orthopedics & Sports Medicine | Bradenton | Florida | 34209 | United States |
| Injury Care Research, LLC | Boise | Idaho | 83713 | United States |
| Exodus Pain Clinic | Meridian | Idaho | 83642 | United States |
| Biogenesis Group, LLC | Ypsilanti | Michigan | 48197 | United States |
| Spokane Joint Replacement Center | Spokane | Washington | 99218 | United States |
| Participants |
|
| Age, Continuous | Mean | Full Range | Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
|
| Participants |
|
|
| 0 |
| 180 |
| 0 |
| 180 |
| 0 |
| 180 |
Publication Rights. Independent analysis and/or publication of data generated or arising from the performance of this Agreement is not permitted without the prior written consent of Regenesis. Such consent may be contingent on Regenesis' review and approval of any proposed analysis and manuscript. Institution will retain the right to review and analyze the database created from this study for its own scientific purposes so long as such scientific purposes are non-commercial in nature.