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to evaluate the effectiveness of cooled radiotherapy denervation of the sacroiliac region using the sinergy system by comparing a treatment group to a placebo group
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Treatment with Sinergy system |
|
| 2 | Placebo Comparator | placebo controlled |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sinergy | Device | radiofrequency denervation |
| |
| Placebo sham |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Status Change for Sacroiliac Joint Pain Intensity | Scale ranges from 0 to 10. A score of 0 represents no pain and a score of 10 represents the highest level of pain. | Baseline and 3 months |
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| Measure | Description | Time Frame |
|---|---|---|
| Pain Status Change for Sacroiliac Joint Pain Intensity | Scale ranges from 0 to 10. A score of 0 represents no pain and a score of 10 represents the highest level of pain. | Baseline and 6 Months |
| Pain Status Change for Sacroiliac Joint Pain Intensity |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nileshkumar Patel, MD | Coastal Orthopedics & Sports Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Coastal Orthopedics & Sports Medicine | Bradenton | Florida | 34209 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Lateral Branch Neurotomy | The lateral branch neurotomy procedure involved the ablation of the S1-S3 lateral branches and the L5 dorsal ramus using cooled radiofrequency electrodes. The procedure was completed one time within 60 days of enrollment. |
| FG001 | Sham Procedure | The sham procedure was identical to the active treatment procedure but without the delivery of radiofrequency energy. The sham procedure was completed one time within 60 days of enrollment. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline to 3 Months |
| |||||||||||||
| 3 Months to 6 Months |
| |||||||||||||
| 6 Month to 9 Months |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Lateral Branch Neurotomy | |
| BG001 | Sham Procedure | |
| BG002 | Total |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| 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 Status Change for Sacroiliac Joint Pain Intensity | Scale ranges from 0 to 10. A score of 0 represents no pain and a score of 10 represents the highest level of pain. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 3 months |
|
|
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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 | Lateral Branch Neurotomy |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Meghal Khakhar, Director of Regulatory and Scientific Affairs | Baylis Medical | 9056024875 | mkhakhar@baylismedical.com |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Device |
sham procedure |
|
Scale ranges from 0 to 10. A score of 0 represents no pain and a score of 10 represents the highest level of pain.
| Baseline and 9 Months |
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|
| NOT COMPLETED |
|
Total of all reporting groups
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Sacroiliac Joint Pain Intensity | Scale ranges from 0 to 10. A score of 0 represents no pain and a score of 10 represents the highest level of pain. | Mean | Standard Deviation | Units on a scale |
|
|
|
| Other Pre-specified | Pain Status Change for Sacroiliac Joint Pain Intensity | Scale ranges from 0 to 10. A score of 0 represents no pain and a score of 10 represents the highest level of pain. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 6 Months |
|
|
|
| Other Pre-specified | Pain Status Change for Sacroiliac Joint Pain Intensity | Scale ranges from 0 to 10. A score of 0 represents no pain and a score of 10 represents the highest level of pain. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 9 Months |
|
|
|
| 0 |
| 34 |
| 0 |
| 34 |
| EG001 | Sham Procedure | 0 | 17 | 0 | 17 |
The results communications must be provided to the Sponsor for review 30 days prior to public release. The Sponsor has the right to review materials for the purposes of preserving confidentiality of Sponsor's proprietary information, which may be removed at the Sponsor's request, and for identification of patentable inventions. The Investigator has no obligation to address any additional comments provided during the review and has final control and approval of publication content.