Real-World Outcomes Study on Subjects Treated With Radiofrequency Ablation

NCT04873817 | Completed Results FDA Device

• 1 other identifier: ABT-CIP-10347
• Study Type: observational
• Target: 184
• Locations: 6 countries
• Sites: 11

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.

Conditions

Pain

Keywords

IonicRF™ Generator; ABT-CIP-10347; Radio frequency ablation (RFA); Chronic pain

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

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.

Device: IonicRF Generator and compatible accessories

Interventions

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

IonicRF Generator and compatible accessories

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• A. 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
• Subject has stable chronic pain medication use for 30 days
• Subject is willing and able to comply with the prescribed follow-up evaluations
• B. 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
• C. 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
• D. Candidate subjects with radicular pain

You may not qualify if:

• A. 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.
• Subject's opioid usage is \> 90 morphine equivalents per day.
• B. Candidate subjects with trigeminal neuralgia
• \. Subject has sensory problems

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (11)

Nura

Edina, Minnesota, 55435, United States

Location

Nevada Advanced Pain Specialists

Reno, Nevada, 89511, United States

Location

Ainsworth Institute of Pain Management

New York, New York, 10022, United States

Location

The Spine & Nerve Center of St Francis Hospital

Charleston, West Virginia, 25301, United States

Location

AZ Delta vzw

Roeselare, West Flanders, 8800, Belgium

Location

Hôpital Privé du Confluent

Nantes, Pays de la Loire Region, 44200, France

Location

Krankenhaus Neuwerk Maria von den Aposteln

Mönchengladbach, N. RHIN, 41066, Germany

Location

Universitätsmedizin Berlin - Charité Campus Mitte

Berlin, 10117, Germany

Location

Stichting Rijnstate Ziekenhuis - Arnhem

Arnhem, Gelderland, 6815 AD, Netherlands

Location

Hospital Puerta del Mar

Cadiz, 11009, Spain

Location

Hospital Clínico Universitario de Valencia

Valencia, 46010, Spain

Location

MeSH Terms

Conditions

Pain; Chronic Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Devyani Nanduri, Sr. Director, Clinical and Regulatory Affairs
• Organization: Abbott

Devyani.Nanduri@abbott.com

+16698329450

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2021
• First Posted: May 5, 2021
• Study Start: June 29, 2021
• Primary Completion: December 16, 2022
• Study Completion: March 8, 2023
• Last Updated: November 20, 2024
• Results First Posted: November 20, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1); NL (1); ES (2); US (4); BE (1); DE (2)