PainROSTRANCT04873817
Real-World Outcomes Study on Subjects Treated With Radiofrequency Ablation
An observational study of Pain, run by Abbott Medical Devices at 11 sites in 6 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain
- What is being tested?
- IonicRF Generator and compatible accessories
- Type of treatment
- Medical device
- How many people
- 184 participants
- Where
- 11 sitesin 6 countries
- Study dates
- 29 Jun 2021to 8 Mar 2023
- Phase
- Observational
- 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
Study population: Subjects of all genders from the general chronic pain population referring to the participating pain clinics will be enrolled in the study.
Who may be able to join
- All candidate subjects
- Subject must provide written informed consent prior to any clinical investigation-related procedure
- Subject is ≥ 18 years of age
- Subject has chronic pain > 6 months and was unresponsive to conservative management
- Subject has pain on an NRS scale of ≥ 6
- Subject is scheduled for an RFA procedure with the IonicRF generator within 30 days of baseline to treat chronic pain at one anatomical region
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- Subject has stable chronic pain medication use for 30 days
- Subject is willing and able to comply with the prescribed follow-up evaluations
- Candidate subjects with facet joint pain (lumbar or cervical)
- Subject has unilateral or bilateral pain on para-spinal palpation and localized pain with extension/lateral bending
- Subject has facet joint pain confirmed by at least 1 positive medial branch block with 0.5 mL or less of anesthetics (across at least 3 vertebral levels) achieving at least 50% pain relief, with real-time injection of radiographic contrast under fluoroscopic guidance
- Candidate subjects with sacroiliac joint pain
- Subject has sacroiliac joint pain based on medical history and physical exam
- Subject has sacroiliac joint pain confirmed by an infiltration of local anesthetics in the posterior part of the sacroiliac joint achieving at least 50% pain relief
- Candidate subjects with radicular pain
- Subject has radicular pain based on medical history and physical exam
- Subject has radicular pain confirmed by dermatomal mapping corresponding to at least 1 nerve root level
- Candidate subjects with trigeminal neuralgia
- Subject has trigeminal pain based on medical history and physical exam
- Subject did not have any mass effect or stroke causing trigeminal pain confirmed by MRI
- Subject is ≥ 60 years of age in case of a neurovascular conflict
- Candidate subjects with knee or hip pain
- Subject has knee or hip pain based on medical history and physical exam
- Subject has radiographically confirmed osteoarthritis of the hip or knee, or has chronic pain following joint arthroplasty
Who cannot join
- All candidate subjects
- Subject is currently participating in another clinical investigation that may confound the results of this study.
- Ongoing systemic or local infection in the area of the procedure.
- Recent use of anticoagulants or subject with coagulopathy.
- Primary complaint of deafferentation pain.
- Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements of the clinical investigation results.
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- Subject's opioid usage is > 90 morphine equivalents per day.
- Candidate subjects with trigeminal neuralgia
- 1. Subject has sensory problems
Trial locations and contacts
11 sites in 6 countries.
11 sites in 6 countries
United States4 sites
The Spine & Nerve Center of St Francis Hospital
Charleston, West Virginia, 25301
Nura
Edina, Minnesota, 55435
Ainsworth Institute of Pain Management
New York, New York, 10022
Nevada Advanced Pain Specialists
Reno, Nevada, 89511
Germany2 sites
Universitätsmedizin Berlin - Charité Campus Mitte
Berlin, 10117
Krankenhaus Neuwerk Maria von den Aposteln
Mönchengladbach, N. RHIN, 41066
Spain2 sites
Hospital Puerta del Mar
Cadiz, 11009
Hospital Clínico Universitario de Valencia
Valencia, 46010
Netherlands1 site
Stichting Rijnstate Ziekenhuis - Arnhem
Arnhem, Gelderland, 6815 AD
About this study
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.
- Conditions
- Pain
- Being tested
- IonicRF Generator and compatible accessories
- Keywords
- IonicRF™ Generator, ABT-CIP-10347, Radio frequency ablation (RFA), Chronic pain
- Medical subject headings
- Pain, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IonicRF Generator and compatible accessoriesDevice
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: IonicRF Generator and compatible accessories |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%.
Measured: 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.
Measured: At 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2021
- Study start29 Jun 2021
- Primary completion16 Dec 2022
- Study completion8 Mar 2023
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 PainStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 184 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04873817
- Sponsor's protocol ID
- ABT-CIP-10347
- Acronym
- ROSTRA
- Status last verified
- Sep 2024
- First submitted
- 4 May 2021
- Last updated
- 20 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-World Outcomes Study on Subjects Treated With Radiofrequency Ablation
- ClinicalTrials.gov ID
- NCT04873817
- Acronym / sponsor ID
- ROSTRA / ABT-CIP-10347
- Conditions
- Pain
- Keywords
- IonicRF™ Generator, ABT-CIP-10347, Radio frequency ablation (RFA), Chronic pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 184 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- 29 Jun 2021 (actual)
- Primary completion
- 16 Dec 2022 (actual)
- Study completion
- 8 Mar 2023 (actual)
- First posted
- 5 May 2021 (actual)
- Results
- Posted 20 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IonicRF Generator and compatible accessories | – | Device: IonicRF Generator and compatible accessoriesIonicRF 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects of all genders from the general chronic pain population referring to the participating pain clinics will be enrolled in the study.
Key inclusion criteria (24 listed)
- All candidate subjects
- Subject must provide written informed consent prior to any clinical investigation-related procedure
- Subject is ≥ 18 years of age
- Subject has chronic pain > 6 months and was unresponsive to conservative management
- Subject has pain on an NRS scale of ≥ 6
Key exclusion criteria (9 listed)
- All candidate subjects
- Subject is currently participating in another clinical investigation that may confound the results of this study.
- Ongoing systemic or local infection in the area of the procedure.
- Recent use of anticoagulants or subject with coagulopathy.
- Primary complaint of deafferentation pain.
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 |
|---|---|---|
| IonicRF Generator and compatible accessoriesParticipants 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 | Device | IonicRF Generator and compatible accessories |
Primary outcome
Primary Effectiveness Endpoint: Relative Change in Numeric Rating Scale (NRS) From Baseline to 3 Months Follow-up Visit
Time frame: Baseline to 3 months
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%.
Primary Safety Endpoint: Incidence of Device- and Procedure-related Serious Adverse Events
Time frame: At 3 months
Number of participants with Device- and Procedure-related Serious Adverse Events.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
11 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, run by Abbott Medical Devices at 11 sites in 6 countries.
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 24 inclusion and 9 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: finished, as of the sponsor's last update on 20 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States, Germany, Spain, Belgium, France and 1 more country. 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. 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 20 Nov 2024). 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?
Primary Effectiveness Endpoint: Relative Change in Numeric Rating Scale (NRS) From Baseline to 3 Months Follow-up Visit (time frame: Baseline to 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Nov 2024.