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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04873817
Recruitment Status : Active, not recruiting
First Posted : May 5, 2021
Last Update Posted : June 30, 2022
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

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.


Condition or disease Intervention/treatment
Pain Device: IonicRF Generator andcompatible accessories

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Study Type : Observational
Actual Enrollment : 180 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Real-World Outcomes Study on Subjects Treated With Radiofrequency Ablation
Actual Study Start Date : June 29, 2021
Estimated Primary Completion Date : September 30, 2022
Estimated Study Completion Date : December 31, 2022

Group/Cohort Intervention/treatment
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 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




Primary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04873817


Locations
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United States, Minnesota
Nura
Edina, Minnesota, United States, 55435
United States, Nevada
Nevada Advanced Pain Specialists
Reno, Nevada, United States, 89511
United States, New York
Ainsworth Institute of Pain Management
New York, New York, United States, 10022
United States, West Virginia
The Spine & Nerve Center of St Francis Hospital
Charleston, West Virginia, United States, 25301
Belgium
AZ Delta vzw
Roeselare, West Flanders, Belgium, 8800
France
Hôpital Privé du Confluent
Nantes, Pays De La Loire, France, 44200
Germany
Krankenhaus Neuwerk Maria von den Aposteln
Monchengladbach, N. Rhin, Germany, 41066
Universitätsmedizin Berlin - Charité Campus Mitte
Berlin, Germany, 10117
Netherlands
Stichting Rijnstate Ziekenhuis - Arnhem
Arnhem, Gelderland, Netherlands, 6815 AD
Spain
Hospital Puerta del Mar
Cadiz, Spain, 11009
Hospital Clínico Universitario de Valencia
Valencia, Spain, 46010
Sponsors and Collaborators
Abbott Medical Devices
Investigators
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Study Director: Brad Maruca Abbott
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Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT04873817    
Other Study ID Numbers: ABT-CIP-10347
First Posted: May 5, 2021    Key Record Dates
Last Update Posted: June 30, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Abbott Medical Devices:
IonicRF™ Generator
ABT-CIP-10347
Radio frequency ablation (RFA)