We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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 : January 4, 2023
Sponsor:
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 January 4, 2023
Actual Study Start Date June 29, 2021
Actual Primary Completion Date December 31, 2022   (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
Change History
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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
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 30, 2023
Actual Primary Completion Date December 31, 2022   (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
Removed Location Countries  
 
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 January 2023