Real-World Outcomes Study on Subjects Treated With Radiofrequency Ablation

Pain Clinical Trial

— ROSTRA  

Official title:

Real-World Outcomes Study on Subjects Treated With Radiofrequency Ablation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04873817
• Other study ID #: ABT-CIP-10347
• Status: Completed
• Start date: June 29, 2021
• Est. completion date: June 30, 2023

Study information

• Verified date: May 2023
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 184
• Est. completion date: June 30, 2023
• Est. primary completion date: March 8, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• 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

Locations

Country	Name	City	State
Belgium	AZ Delta vzw	Roeselare	West Flanders
France	Hôpital Privé du Confluent	Nantes	Pays De La Loire
Germany	Universitätsmedizin Berlin - Charité Campus Mitte	Berlin
Germany	Krankenhaus Neuwerk Maria von den Aposteln	Monchengladbach	N. Rhin
Netherlands	Stichting Rijnstate Ziekenhuis - Arnhem	Arnhem	Gelderland
Spain	Hospital Puerta del Mar	Cadiz
Spain	Hospital Clínico Universitario de Valencia	Valencia
United States	The Spine & Nerve Center of St Francis Hospital	Charleston	West Virginia
United States	Nura	Edina	Minnesota
United States	Ainsworth Institute of Pain Management	New York	New York
United States	Nevada Advanced Pain Specialists	Reno	Nevada

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Countries where clinical trial is conducted

United States,  Belgium,  France,  Germany,  Netherlands,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Baseline to 3 months
Primary	Primary Safety Endpoint: Incidence of device- and procedure-related serious adverse events	The device- and procedure-related serious adverse events will be summarized as frequency, proportion and number of events per patient years of follow-up.	At 3 months