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ROSTRA is an international, prospective, non-randomized, single-arm, multi-center, and post-market study to collect real-world safety and effectiveness data on Abbott's IonicRF™Generator and compatible RFA accessories. This post-market study is intended to satisfy EU MDR requirements.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IonicRF Generator and compatible accessories | IonicRF Radiofrequency Generator, along with any country-specific market-released accessory (i.e. electrode, cannula, grounding pad, and adaptor cable) compatible with the IonicRF Generator will be used. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IonicRF Generator and compatible accessories | Device | Participants will receive IonicRF lesion generator, along with any country-specific market-released accessory (i.e. electrode, cannula, grounding pad, and adaptor cable) compatible with the IonicRF Generator |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Effectiveness Endpoint: Relative Change in Numeric Rating Scale (NRS) From Baseline to 3 Months Follow-up Visit | The pain NRS consists of 1 question that will be asked by interviewing the subjects. Patients will be asked to rate, from 0 (no pain) to 10 (worst imaginable pain), their average pain over the past 24 hours specific to the area(s) of chronic pain being treated. A higher score indicates greater pain intensity. The presented outcome denotes the mean relative change in NRS score, which was defined as (Baseline score - 3-month follow-up visit score)/ Baseline score*100%. Higher scores indicate greater relative pain relief. Minimum value is 0% and maximum value is 100%. | Baseline to 3 months |
| Primary Safety Endpoint: Incidence of Device- and Procedure-related Serious Adverse Events | Number of participants with Device- and Procedure-related Serious Adverse Events. | At 3 months |
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Inclusion Criteria:
A. All candidate subjects
B. Candidate subjects with facet joint pain (lumbar or cervical)
C. Candidate subjects with sacroiliac joint pain
D. Candidate subjects with radicular pain
E. Candidate subjects with trigeminal neuralgia
F. Candidate subjects with knee or hip pain
Exclusion Criteria:
A. All candidate subjects
B. Candidate subjects with trigeminal neuralgia
1. Subject has sensory problems
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Subjects of all genders from the general chronic pain population referring to the participating pain clinics will be enrolled in the study.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nura | Edina | Minnesota | 55435 | United States | ||
| Nevada Advanced Pain Specialists |
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The study has enrolled 184 subjects at 11 clinical sites in EU and the US. The total duration of the study is expected to be 20 months, including enrollment, data collection from all subjects, and study closeout.
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| ID | Title | Description |
|---|---|---|
| FG000 | IonicRF Generator and Compatible Accessories | IonicRF Radiofrequency Generator, along with any country-specific market-released accessory (i.e. electrode, cannula, grounding pad, and adaptor cable) compatible with the IonicRF Generator will be used. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Subjects who received RF treatment. A total of five enrolled subjects did not receive RF treatment and were considered deregistered.
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| ID | Title | Description |
|---|---|---|
| BG000 | IonicRF Generator and Compatible Accessories | IonicRF Radiofrequency Generator, along with any country-specific market-released accessory (i.e. electrode, cannula, grounding pad, and adaptor cable) compatible with the IonicRF Generator will be used. |
| 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 | Primary Effectiveness Endpoint: Relative Change in Numeric Rating Scale (NRS) From Baseline to 3 Months Follow-up Visit | The pain NRS consists of 1 question that will be asked by interviewing the subjects. Patients will be asked to rate, from 0 (no pain) to 10 (worst imaginable pain), their average pain over the past 24 hours specific to the area(s) of chronic pain being treated. A higher score indicates greater pain intensity. The presented outcome denotes the mean relative change in NRS score, which was defined as (Baseline score - 3-month follow-up visit score)/ Baseline score*100%. Higher scores indicate greater relative pain relief. Minimum value is 0% and maximum value is 100%. | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | Mean | Standard Deviation | score on a scale | Baseline to 3 months |
|
3 Months
The safety endpoints were evaluated at 3 months follow-up. A total of 162 patients completed 3-month follow-up.
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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 | IonicRF Generator and Compatible Accessories | IonicRF Radiofrequency Generator, along with any country-specific market-released accessory (i.e. electrode, cannula, grounding pad, and adaptor cable) compatible with the IonicRF Generator will be used. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Devyani Nanduri, Sr. Director, Clinical and Regulatory Affairs | Abbott | +16698329450 | Devyani.Nanduri@abbott.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 | Jun 4, 2021 | Aug 21, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 30, 2021 | Aug 21, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Reno |
| Nevada |
| 89511 |
| United States |
| Ainsworth Institute of Pain Management | New York | New York | 10022 | United States |
| The Spine & Nerve Center of St Francis Hospital | Charleston | West Virginia | 25301 | United States |
| AZ Delta vzw | Roeselare | West Flanders | 8800 | Belgium |
| Hôpital Privé du Confluent | Nantes | Pays de la Loire Region | 44200 | France |
| Krankenhaus Neuwerk Maria von den Aposteln | Mönchengladbach | N. RHIN | 41066 | Germany |
| Universitätsmedizin Berlin - Charité Campus Mitte | Berlin | 10117 | Germany |
| Stichting Rijnstate Ziekenhuis - Arnhem | Arnhem | Gelderland | 6815 AD | Netherlands |
| Hospital Puerta del Mar | Cadiz | 11009 | Spain |
| Hospital Clínico Universitario de Valencia | Valencia | 46010 | Spain |
| Additional Chronic Pain Treatment for The Same Anatomical Region |
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| Other Reasons |
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| years |
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| 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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| Duration of Chronic Pain (Years) | Mean | Standard Deviation | years |
|
| Number of diagnostic blocks provided to participants prior to therapy implementation | A diagnostic block is an injection of a local anesthetic near the area of pain prior to therapy implementation. A favorable response to the diagnostic block (≥50% pain relief) indicates that the nerve is suitable for RF treatment. | Count of Participants | Participants |
|
| Pain Relief after the first diagnostic block | Minimum is 0% and Maximum is 100%. | Mean | Standard Deviation | units on a scale |
|
| Pain Relief after second diagnostic block | Minimum is 0% and Maximum is 100%. | Mean | Standard Deviation | units on a scale |
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IonicRF Radiofrequency Generator, along with any country-specific market-released accessory (i.e. electrode, cannula, grounding pad, and adaptor cable) compatible with the IonicRF Generator will be used.
|
|
|
| Primary | Primary Safety Endpoint: Incidence of Device- and Procedure-related Serious Adverse Events | Number of participants with Device- and Procedure-related Serious Adverse Events. | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | Count of Participants | Participants | At 3 months |
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| 0 |
| 162 |
| 0 |
| 162 |
| 0 |
| 162 |