Real-World Outcomes Study on Subjects Treated With Radiofrequency Ablation (ROSTRA)

• ClinicalTrials.gov Identifier: NCT04873817
• Recruitment Status: Active, not recruiting
• First Posted: May 5, 2021
• Last Update Posted: March 24, 2023
• Sponsor: Abbott Medical Devices
• Information provided by (Responsible Party): Abbott Medical Devices

Tracking Information

• First Submitted Date: May 4, 2021
• First Posted Date: May 5, 2021
• Last Update Posted Date: March 24, 2023
• Actual Study Start Date: June 29, 2021
• Actual Primary Completion Date: March 8, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 4, 2021)

• 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.
• Primary Safety Endpoint: Incidence of device- and procedure-related serious adverse events [ Time Frame: At 3 months ]
  The device- and procedure-related serious adverse events will be summarized as frequency, proportion and number of events per patient years of follow-up.

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Real-World Outcomes Study on Subjects Treated With Radiofrequency Ablation
• Official Title: Real-World Outcomes Study on Subjects Treated With Radiofrequency Ablation

Brief 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.

The study will enroll up to 180 subjects at up to 10 sites in Europe and the United States.

The total duration of the study is expected to be 19 months, including enrollment, data collection from all subjects, and study closeout.

• Detailed Description: Not Provided
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: Subjects of all genders from the general chronic pain population referring to the participating pain clinics will be enrolled in the study.
• Condition: Pain

Intervention

Device: IonicRF Generator andcompatible accessories

Participants will recieve IonicRFRF lesion generator, along with any country-specific market-released accessory (i.e. electrode,cannula, grounding pad, and adaptor cable) compatible with theIonicRF Generator

Study Groups/Cohorts

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.

Intervention: Device: IonicRF Generator andcompatible accessories

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: January 3, 2023): 184
• Original Estimated Enrollment (submitted: May 4, 2021): 400
• Estimated Study Completion Date: April 21, 2023
• Actual Primary Completion Date: March 8, 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

A. All candidate subjects

1. Subject must provide written informed consent prior to any clinical investigation-related procedure
2. Subject is ≥ 18 years of age
3. Subject has chronic pain > 6 months and was unresponsive to conservative management
4. Subject has pain on an NRS scale of ≥ 6
5. Subject is scheduled for an RFA procedure with the IonicRF generator within 30 days of baseline
6. Subject has stable chronic pain medication use for 30 days
7. Subject is willing and able to comply with the prescribed follow-up evaluations

B. Candidate subjects with facet joint pain (lumbar or cervical)

1. Subject has unilateral or bilateral pain on para-spinal palpation
2. Subject has facet joint pain confirmed by at least 1 positive medial branch block with 0.5 mL or less of anesthetics achieving at least 50% pain relief, with real-time injection of radiographic contrast under fluoroscopic guidance

C. Candidate subjects with sacroiliac joint pain

1. Subject has sacroiliac joint pain confirmed by an infiltration (with bony contact on 3 vertebral levels) of local anesthetics in the posterior part of the sacroiliac joint achieving at least 50% pain relief

D. Candidate subjects with radicular pain

1. Subject has radicular pain confirmed by sensory mapping across at least 1 vertebral level

E. Candidate subjects with trigeminal neuralgia

1. Subject has trigeminal pain elicited using a provocation test (e.g. contact with toothbrush)
2. Subject has sudden, non-continuous pain
3. Subject did not have any mass effect or stroke causing trigeminal pain confirmed by MRI
4. Subject has attempted anti-neuropathic medication with no improvement of symptoms

F. Candidate subjects with knee or hip pain

1. Subject has radiographically confirmed osteoarthritis of the hip or knee, or has chronic pain following joint arthroplasty
2. Subject has knee or hip pain confirmed by sensory mapping and/or diagnostic block(s)

Exclusion Criteria:

A. All candidate subjects

1. Subject is currently participating in another clinical investigation that may confound the results of this study.
2. Ongoing systemic or local infection in the area of the procedure.
3. Recent use of anticoagulants or subject with coagulopathy.
4. Primary complaint of deafferentation pain.
5. 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.
6. Subject's opioid usage is > 90 morphine equivalents per day.

B. Candidate subjects with trigeminal neuralgia

1. Subject has sensory problems

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Belgium, France, Germany, Netherlands, Spain, United States

Administrative Information

• NCT Number: NCT04873817
• Other Study ID Numbers: ABT-CIP-10347
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Abbott Medical Devices
• Original Responsible Party: Same as current
• Current Study Sponsor: Abbott Medical Devices
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Abbott Medical Devices
• Verification Date: March 2023