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

Sponsor
Abbott Medical Devices (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04873817
Collaborator
(none)
180
11
18.1
16.4
0.9

Study Details

Study Description

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 Phase
  • Device: IonicRF Generator andcompatible accessories

Study Design

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 :
Jun 29, 2021
Anticipated Primary Completion Date :
Sep 30, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Primary effectiveness endpoint: Relative change in Numeric Rating Scale (NRS) from baseline to 3 months follow-up visit [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. 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

  1. 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

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

  1. 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:
  1. 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.

  1. Candidate subjects with trigeminal neuralgia
  1. Subject has sensory problems

Contacts and Locations

Locations

Site City State Country Postal Code
1 Nura Edina Minnesota United States 55435
2 Nevada Advanced Pain Specialists Reno Nevada United States 89511
3 Ainsworth Institute of Pain Management New York New York United States 10022
4 The Spine & Nerve Center of St Francis Hospital Charleston West Virginia United States 25301
5 AZ Delta vzw Roeselare West Flanders Belgium 8800
6 Hôpital Privé du Confluent Nantes Pays De La Loire France 44200
7 Krankenhaus Neuwerk Maria von den Aposteln Monchengladbach N. Rhin Germany 41066
8 Universitätsmedizin Berlin - Charité Campus Mitte Berlin Germany 10117
9 Stichting Rijnstate Ziekenhuis - Arnhem Arnhem Gelderland Netherlands 6815 AD
10 Hospital Puerta del Mar Cadiz Spain 11009
11 Hospital Clínico Universitario de Valencia Valencia Spain 46010

Sponsors and Collaborators

  • Abbott Medical Devices

Investigators

  • Study Director: Brad Maruca, Abbott

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Abbott Medical Devices
ClinicalTrials.gov Identifier:
NCT04873817
Other Study ID Numbers:
  • ABT-CIP-10347
First Posted:
May 5, 2021
Last Update Posted:
Jun 30, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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

Study Results

No Results Posted as of Jun 30, 2022